Pharma Intelligence Podcasts: Recent Episodes
Informa
Pharma Intelligence from Informa places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Informa is a leader in the field of healthcare industry information.
Cereno Scientific CEO Sten Sörensen discusses how his company is repurposing a 60-year-old epilepsy drug as a potential game-changer for pulmonary arterial hypertension and idiopathic pulmonary fibrosis. Learn about their promising Phase IIa results that showed improved heart function and reduced mortality risk, the FDA fast track designation they recently received, and their strategy for advancing two rare disease programs toward pivotal trials. A fascinating look at drug repurposing, epigenetic modulation, and the challenges of developing therapies for high unmet need patient populations.
Listen now as Citeline speaks with top executives from Perceptive to understand eClinical’s major reset and what it means for the future of clinical trials. Learn more about IRT’s evolving role, lessons learned, and how tech will rule the data-driven trials of the future.
本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月3日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: 辉瑞暗箱操作美国定价协议；日本药品关税政策引发争议；美国直供患者计划持续扩张；诺华瑞美布替尼获首次批准；葛兰素史克首席执行官即将卸任。https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-NYTAMV4KPFCB3PSCCQMKIF2CEA/Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX
Celebrating Europe’s Consumer Health Best Practice, With AESGP’s Luis Rhodes BaiaoThe Association of the European Self-Care Industry, or AESGP, has launched a digital platform that brings together inspiring self-care initiatives from across Europe. Launched to coincide with International Self-Care Day 2025, AESGP’s Self-Care Insight and Inspire platform showcases national-level initiatives led or supported by the consumer health industry in collaboration with healthcare professionals, sectoral associations, and public authorities. In this episode of the Over the Counter podcast, AESGP governmental and public affairs manager, Luis Rhodes Baiao, tells HBW Insight about the background behind the platform and pulls out some of his favourite examples.Timestamps2:00 – Introductions5:15 – AESGP’s Self-Care Insight and Inspire platform14:30 – Luis’s favourite examples17:30 – Public reaction to the campaign18:50 – Next steps20:30 – How to get involvedGuest BioLuis Rhodes Baiao is governmental and public affairs Manager at AESGP. Before, he was policy advisor to a Portuguese Member of the European Parliament on the Committee for Environment, Public Health and Food Safety (ENVI), during the mandate 2014 to 2019. He is currently also vice-president of the General Assembly of the Association Public Affairs Portugal (PAPT).
Audio roundup of selected biopharma industry content from Scrip over the business week ended October 3, 2025. In this episode: Pfizer’s backroom US pricing deal; confusion over Japan’s pharma tariffs; more direct-to-patient schemes in the US; first approval for Novartis’s remibrutinib; and GSK’s CEO to step down. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-NYTAMV4KPFCB3PSCCQMKIF2CEA/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and senior editors Sue Sutter and Cathy Kelly consider the impact of the government shutdown on the US Food and Drug Administration, as well as industry (:21), and discuss the future of drug pricing after Pfizer completes its deal with the White House to embrace its Most Favored Nation plan (10:29). More On These Topics From The Pink SheetShutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-approaches-us-fda-would-retain-most-of-recently-trimmed-staff-DTVAHLBI5VGZBPHD76TLNDIBGU/ Shutdown Day One: US FDA Hiring, MFN Demos Delayed?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-day-one-us-fda-hiring-mfn-demos-delayed-7LGCITF2WVCJNEVUTWZV5MOZSE/ Closing The Gap? Pfizer Will Set Same US, Foreign Launch Prices In MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/closing-the-gap-pfizer-will-set-same-us-foreign-launch-prices-in-mfn-deal-ZRSNU56KTFGRBBX4Y5OJKLFV6Y/ Questions Persist About How Pfizer’s US Agreement Lowers Prices: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/questions-persist-about-how-pfizers-us-agreement-lowers-prices-T2TEWMKVMVHGJHPXDKIFDF2GWA/
本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月26日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻：辉瑞通过收购Metsera重返肥胖治疗领域；罗氏勾勒肥胖治疗战略蓝图；UniQure公司亨廷顿病基因疗法取得积极进展；百时美施贵宝计划在英国采用美国定价策略推广Cobenfy；疫苗质疑情绪影响商业化前景。https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HCVAK32IGREDHMH5D4I3RFY6AA/Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX
Audio roundup of selected biopharma industry content from Scrip over the business week ended September 26, 2025. In this episode: Pfizer jumps back into obesity with Metsera bid; Roche maps out its obesity ambitions; UniQure’s encouraging gene therapy results for Huntington’s; BMS plans US pricing for Cobenfy in the UK; and vaccine skepticism affects vaccine commercial prospects. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HCVAK32IGREDHMH5D4I3RFY6AA/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Generics Bulletin editor Dave Wallace talks to John Murphy III, president and CEO of the US Association for Accessible Medicines, about the association's latest annual savings report and key topics affecting the US off-patent market.
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「EFPIA Rallies EU To Shield Innovative Drugs After US Tariff Cap Is Confirmed（邦訳：欧州製薬団体、医薬品への米国関税適用に反発 EUへ対策を要請）」URL: https://insights.citeline.com/pink-sheet/compliance/manufacturing/efpia-rallies-eu-to-shield-innovative-drugs-after-us-tariff-cap-is-confirmed-HYZJDK4S7NGT3FUEBA5AFSYYT4/Playlist: soundcloud.com/citelinesounds/sets/japanese-language-mini
本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月19日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期内容——GSK在特朗普访英期间宣布美国投资计划； 礼来公司对英国实验室投资三思而后行；解析中国研发与并购热潮；再生元CEO谈被忽视的重磅产品；阿斯利康COPD试验受挫。https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4VJFG2XNJGAJEFGSXNEQUA3BU/China Webinar sign up: https://www.citeline.com/en/events/china-transforming-pharma Playlist: https://on.soundcloud.com/gnr7PaOwflNKiAO7QX
Audio roundup of selected biopharma industry content from Scrip over the business week ended September 19, 2025. In this episode: GSK announces US investments during Trump’s UK visit; Lilly thinks twice about UK lab investment; analyzing the rise in China R&D and deals; Regeneron CEO on his company’s ignored blockbusters; and AstraZeneca’s COPD trial failure. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4VJFG2XNJGAJEFGSXNEQUA3BU/Sign up for China R&D webinar: https://www.citeline.com/en/events/china-transforming-pharmaThis episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Hear from ICROM CEO Pierfrancesco Morosini and HOLODIAG GM Pierric Marchand as they discuss how the company is advancing HPAPI development, solid-state science, and flexible CDMO services. Topics include OEB5/6 capabilities, a new kilo-scale unit, and the impact of electron diffraction on drug development.
本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月12日当周的生物制药行业的商业动态。本期要闻——诺和诺德裁员9000人；诺华心脏病业务板块交易焕新； 强生Inlexto获批；Summit公司ivonescimab面临挑战；FDA严打直接面向消费者广告。https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XQF6667ICBDMTFBCUCNYBZUJZY/本期节目采用人工智能文本转语音及语音仿真技术制作。
Audio roundup of selected biopharma industry content from Scrip over the business week ended September 12, 2025. In this episode: Novo Nordisk cuts 9,000 jobs; deals freshen up Novartis’s cardio franchise; J&J’s Inlexto approval; Summit’s ivonescimab challenges; and FDA’s DTC ad crackdown. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XQF6667ICBDMTFBCUCNYBZUJZY/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs look at the potential consequences of the US Food and Drug Administration’s upcoming crack down on direct-to-consumer advertising (:30), including the first publicly released letter, which went to AstraZeneca for a Flumist TV commercial (2:50), as well as vaccine policy and other major issues that were listed in the Make America Healthy Again Commission’s Strategy Report (21:45).More On These Topics From The Pink SheetDirect-To-Consumer Ads: Manufacturers Face ‘Cease And Desist’ Orders Now, Uncertain Future: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/direct-to-consumer-ads-manufacturers-face-cease-and-desist-orders-now-uncertain-future-6XLXAWS7WJBYNPHSBRAQVTBARU/ Limited Detail In MAHA Strategy Report Could Catch Pharma Off Guard: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/limited-detail-in-maha-strategy-report-could-catch-pharma-off-guard-TVL7CCBQONA7PHCLUDJ7WTEJC4/
What makes a biotech-CRO partnership truly work? Claire Riches, VP, Clinical Solutions, Citeline, and Matt Simmons, Senior Director, Oncology Strategy, IQVIA Biotech, share the secrets behind winning biotech-CRO partnerships, covering collaboration, transparent budgeting, regulatory navigation, and recruitment strategies, with essential insights to help biotechs succeed from their first RFP to global trials.View the video series and find out more information here: https://www.citeline.com/biotech
Community based trials are reshaping clinical research, broadening patient access and accelerating timelines. Discover the drivers, challenges and future outlook.
In Vivo spoke with Annette Bakker, CEO of the Children’s Tumor Foundation, a medical research foundation developing an innovative approach to reviving shelved pharmaceutical assets, resulting in the recent US FDA approval of mirdametinib, a treatment for rare tumors.
Audio roundup of selected biopharma industry content from Scrip over the business week ended September 5, 2025. In this episode: the US MASH market after Wegovy’s approval; AstraZeneca and Mineralys in close hypertension race; United Therapeutics’ Phase III win in IPF; Corsera aims to predict and prevent cardiovascular disease; and Ionis’s RNA-targeted win in severe hypertriglyceridemia. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RKP4E4CFGFGGXBRVXTI73V27U4/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
For today’s consumers, sustainability is an expectation rather than a luxury, according to PA Consulting’s latest Brand Impact Index. In other words, companies that haven’t invested in minimizing their brands’ impact on the environment are at risk of being left behind. “But it’s ok to get it wrong sometimes too,” notes PA’s personalization and consumer expert, Rhea Patten, in this episode of HBW Insight’s Over the Counter podcast. And maybe for smaller brands, being a staller rather than a shaper may also make strategic, short-term sense, as long as consumers can understand that sustainability is their long-term goal. Don’t mis the first part of this interview with Patten, in which we discussed, among other things, what “vibes” are and how understanding this aspect of “consumer centricity” better can help consumer health companies grow their brands.Timestamps2:00 – Do consumers still want sustainable brands?8:00 – Will consumers forgive sustainability missteps?10:00 – Will consumers pay more for sustainable brands?13:00 – Is better to be a sustainability shaper or staller?15:30 – Final thoughtsGuest BioRhea Patten is a consumer product expert at PA Consulting, with expertise in health, beauty, and wellness. She has over 20 years’ experience in leading innovation and transformation projects in the consumer products and retail sector. Passionate about bridging physical products with digital experiences, Patten helps leaders deliver solutions that drive business growth. She specializes in accelerating product innovation, with a focus on strategy, customer-centricity, and sustainability.
Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47).More On These Topics From The Pink SheetOffit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/
In this episode of the China Biopharma English-language Podcast, Shanghai-based senior reporter Xu Hu talks about the release for the first time by China’s National Healthcare Security Administration in August of a preliminary list of innovative drugs reimbursed by commercial insurance and the key reasons that have driven this reform. Related story links:https://insights.citeline.com/pink-sheet/geography/asia/china/china-signals-commercial-insurance-biotech-and-foreign-owned-hospitals-as-policy-priorities-6WABWKHO3VCRHNSCOXGABSHTZE/ https://insights.citeline.com/pink-sheet/market-access/government-payers/china-unveils-multiple-policies-to-support-innovative-drugs-throughout-life-cycle-JFEHXBAS2ND3PGJYKOF7NB6ZCM/https://insights.citeline.com/pink-sheet/geography/asia/china/china-nhsa-releases-preliminary-innovative-drug-list-for-first-time-JOSACB66CZA6BOZNDEGFTLLWSU/
Audio roundup of selected biopharma industry content from Scrip over the business week ended August 29, 2025. In this episode: Lilly’s orforglipron strong in diabetic obesity; Ascletis confident in oral GLP-1 challenger; myostatin drugs progress for obesity; an interview with OneSource’s CEO; and an analysis of Dupixent’s pipeline-in-a-product success. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KKZ7ZW3B2VGUBFTSLNCLIHU7QU/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration’s COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20). More On These Topics From The Pink SheetCOVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/ US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/ A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/ Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/
As global regulatory expectations evolve, biotech sponsors face growing pressure to make smarter, earlier decisions about where and how to run their trials. In this episode, Novotech experts Renita Hite (Director of Regulatory Affairs, Drug Development Consulting) and Scott Schliebner (Global Head of Drug Development Consulting) join moderator Meredith Landry to discuss how early-stage sponsors can adapt to shifting FDA initiatives, accelerated global pathways, and increasing demands for regulatory flexibility. They explore:How new FDA initiatives—like AI-driven reviews, user fee changes, and the National Priority Voucher—are reshaping IND strategyWhy sponsors should design trials with global data packages in mind from day oneAccelerated and early access pathways that can speed startup and market entryHow CROs are evolving to help sponsors prioritize markets and build regulatory flexibility If you’re planning trials for 2025 and beyond, this conversation will help you prepare for what’s next—and position your program for long-term success. About This EpisodeThis episode is the final installment (4 of 4) in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Catch up on earlier episodes:[Part 1: Navigating Regulatory Changes & Market Dynamics][Part 2: Navigating Regulatory & Market Shifts][Part 3: Navigating Regulatory Changes & Market Dynamics]
전통적 벤처캐피털이 점점 더 신중하고 선별적인 투자 성향으로 변하면서 바이오 기업들이 새로운 자본 조달 경로를 모색하고 있다는 Citeline의 In Vivo 기사를 요약한 내용입니다.https://insights.citeline.com/in-vivo/growth/when-vc-steps-back-finding-alternative-biotech-funding-4UN5IYJEUZD2XPLYIZ7RR7YVQY/ Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「China NHSA Releases Preliminary Innovative Drug List For First Time（邦訳：中国国家医療保障局、初の画期的医薬品向け償還“候補”リストを発表）」URL: https://insights.citeline.com/pink-sheet/geography/asia/china/china-nhsa-releases-preliminary-innovative-drug-list-for-first-time-JOSACB66CZA6BOZNDEGFTLLWSU/ ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip Playlist: https://soundcloud.com/citelinesounds/sets/japanese-language-mini
Despite the recent pressure on their finances, consumers are rejecting the idea of choosing brands based on cost alone, according to PA Consulting’s latest Brand Impact Index. People are prepared to pay more for brands they “vibe” with, PA suggests. But what are vibes? And how can consumer health companies tap into them? As PA personalisation and consumer expert Rhea Patten explains in this episode of HBW Insight’s Over the Counter podcast, vibing with consumers means making them feel special, seen and heard, and creating communities around their needs. Timestamps:2:00 – Introductions3:00 – The Brand Impact Index4:30 – This year’s headline findings6:30 – What OTC firms can learn from leading beauty and wellness brands17:00 – What are “vibes”?25:00 – How to build a brand communityGuest Bio:Rhea Patten is a consumer product expert at PA Consulting, with expertise in health, beauty, and wellness. She has over 20 years’ experience in leading innovation and transformation projects in the consumer products and retail sector. Passionate about bridging physical products with digital experiences, Patten helps leaders deliver solutions that drive business growth. She specialises in accelerating product innovation, with a focus on strategy, customer-centricity, and sustainability.
Audio roundup of selected biopharma industry content from Scrip over the business week ended August 22, 2025. In this episode: Madrigal regains MASH lead with EU Rezdiffra approval; Viking’s obesity data scare investors; China assets lead GLP-1 deals; CSL and others restructure; and Indegene exec on DTP and MFN policies. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T77LV22VANAL5GNPCC2YUVLZBE/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Merck KGaA's Emre Ozcan outlines the company's systematic approach to integrating digital solutions across the care continuum in specialty pharmaceuticals, moving from technology-first to patient-need-first strategies.
Tevard Biosciences CEO Daniel Fischer discusses how engineered suppressor tRNAs enable read-through of premature stop codons to restore full-length protein production in genetic diseases. Fischer, whose daughter has Dravet syndrome, covers the company's lead programs in dilated cardiomyopathy and DMD, advantages over traditional gene therapy approaches, and the path to human proof-of-concept.
Audio roundup of selected biopharma industry content from Scrip over the business week ended August 15, 2025. In this episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-365OXHOS2RFXHPEDQIURY6LFDI/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Audio roundup of selected biopharma industry content from Scrip over the business week ended August 8, 2025. In this episode: Trump ups pressure on MFN pricing; Pfizer says pharma working with Trump on direct sales; Sanofi says direct sales worth considering: Aurigene Oncology CEO on biotech valuations and more; and Novartis progresses pipeline-in-a-product assets.https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RCXSH2B5EVCC3IIK35GXUSNZVA/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
It’s been about three years since Haleon became a standalone self-care company. Since then, the firm has announced an ambitious plan to reach one billion more consumers by 2030. In this episode of HBW Insight’s Over the Counter podcast, we catch up with Haleon’s new UK & Ireland general manager Jo Cooper to find out what that means in practice when translated to the firm’s home market. Empowering pharmacists is key to Cooper’s local plans, as is exploring the opportunities suggested by the UK government’s recently published list of Rx-to-OTC switches it would like to see applications for. Timestamps2:00 – Introductions4:00 – Becoming consumer focused10:00 – Attracting talent into consumer health 13:00 – Translating Haleon’s ambitious global growth strategy to a local context25:00 – The importance of pharmacy30:00 – Rx-to-OTC switch and Haleon’s R&D strategy38:00 – Unpacking Haleon’s “strategic category realignment
Dr Murali Ramachandra, CEO of Aurigene Oncology, talks to Anju Ghangurde about the tough biotech funding environment, promising pipeline assets including a CAR-T cell therapy in Phase II and ‘hybrid’ manufacturing options, besides outcome-based reimbursement models. The promise of bispecifics and multispecifics in oncology, including Chinese biotech Akeso’s PD-1/VEGF bispecific antibody, are some of the other topics he discussed.
In the latest episode of the In Vivo Podcast, Jeremy Skillington, CEO of Poolbeg Pharma, discussed the company’s ambitious pipeline and strategic direction.
Audio roundup of selected biopharma industry content from Scrip over the business week ended August 1, 2025. In this episode: EU tariff deal leaves questions for pharma; Prasad’s CBER exit could bode well for genetic medicines; Winrevair grows but Merck & Co. plans cost cuts; Novo Nordisk selects new CEO; and a look at obesity past the GLP-1s. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-AOJAANRHLNCPNNLNGVVKA3HEAE/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Amid growing uncertainty in the U.S. regulatory landscape, sponsors are increasingly looking to ex-U.S. markets as a strategic way to reduce clinical trial risk and maintain momentum. In this episode, Novotech experts Renita Hite and Scott Schliebner discuss how biotech and small to mid-sized pharma companies are adapting their global trial strategies—leveraging regions like APAC and Eastern Europe for faster startups, strong data quality, and significant cost savings. They explore: -Why sponsors are increasingly looking outside the U.S. amid regulatory and political uncertainty-Key benefits of ex-U.S. regions like APAC and Eastern Europe, including speed, quality, and cost savings-Strategic considerations for integrating global sites into clinical development plans-Common pitfalls and risk mitigation strategies when operating in international markets-How ex-U.S. trials support greater flexibility and resilience heading into 2025–2026 This episode is part 3 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials. Listen to part 1 here: Podcast Series: Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials Listen to part 2 here: Podcast Series: Navigating Regulatory & Market Shifts — CRO Perspectives on Clinical Trials
Listen to learn more about the evolving landscape of rheumatoid arthritis treatment through the lens of the patient experience. One RA patient shares her insights as Advanced Clinical discusses the results from a recent RA patient experience survey.
Healthy aging has been identified as an important trend that consumer healthcare companies need to respond to. According to founder and managing director of UK firm Prime Fifty, Max Gowland, innovating in this area requires understanding the science behind healthy aging and offering consumers specific and efficacious products, rather than catch-all solutions. In this episode of HBW Insight’s Over the Counter podcast, Gowland dives into some of the science behind targeted nutrition for over fifties and explains why appearing on TV shopping channels like QVC has offered a useful way to communicate these benefits to older consumers. Timestamps:2:00 – Introductions5:45 – Leveraging consumer health industry experience8:15 – Prevention is key10:30 – Competing for shelf space13:30 – Be a specialist not a generalist14:30 – Selling via shopping TV17:30 – Why science and quality is important in healthy aging supplementation24:00 – Addressing musculoskeletal health 32:00 – Getting your claims right36:00 – What’s next for Prime FiftyGuest Bio:Max Gowland is a PhD-qualified biochemist with over 40 years’ experience in health and nutrition. He is a leading expert on shaping the nation on providing supplements for 50+ and his focus includes helping support longevity through supplementation to support bone health, skin, hair, nails and more. Having worked with many large companies, Gowland founded Prime Fifty focusing on healthy ageing and currently serves as Chief Scientific Officer at FutureYou Cambridge. Gowland regularly appears on QVC and at industry events to promote evidence-based nutritional support for midlife and beyond.
Audio roundup of selected biopharma industry content from Scrip over the business week ended July 25, 2025. In this episode: Sanofi’s Vicebio buy; Sarepta halts US Elevidys shipments; Novartis warning over Europe; US CRL for Genentech’s Columvi; and an interview with Novavax. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-U4IN5X7DRVFLVIBJ4Q72VTAJUY/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the issues awaiting George Tidmarsh, the new director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (:24), as well as the next steps for the agency and Sarepta amid the ongoing problems with its gene therapy Elevidys (delandistrogene moxeparvovec) (23:49).More On These Topics From The Pink SheetWill Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-news-pharma-ceo-george-tidmarsh-named-director-of-us-fdas-drug-center-2HXJJCPAIVB2RFNGDDU5NZVNQQ/Business Background Of New CDER Director George Tidmarsh: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/business-background-of-new-cder-director-george-tidmarsh-BROCYQDUYFE3LIQDJ2JNBDWD6Y/ US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-cancer-reviewers-heading-for-the-exits-potentially-impacting-review-timelines-YMOFTXDFDZBGVGBIKFXHJY5XTY/ US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-biologics-center-departures-grew-before-more-than-100-rifs-exited-2LR3ZFYOBND3DLIWXSFFWWLFYE/ After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/after-sarepta-reversed-course-on-elevidys-could-an-adcomm-be-next-ZA5ODQB3DJF4LBDFODMB52DM3M/ Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-asks-sarepta-to-stop-elevidys-shipments-after-third-death-linked-to-gene-therapy-vector-GLJ2YJDJGNBPLD3SSKKE6UVM34/
MoonLake Immunotherapeutics is racing ahead in the biotech space with its innovative nanobody SLK and a transformative $500m non-dilutive financing deal. Its CEO and CFO discuss with In Vivo the company’s rapid clinical progress, financial strategy and ambitions to reshape inflammatory disease.
Audio roundup of selected biopharma industry content from Scrip over the business week ended July 18, 2025. In this episode: – J&J delivers in Q2 despite Stelara drop; Sarepta cuts jobs as Elevidys slumps; AI is inevitable but needs to be applied appropriately; China’s mid-cap companies thrive; and a look behind Glenmark’s landmark trispecific deal. Article links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HYQOHZ42CNCQRPF6HCKGLTHUKM/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Scrip discusses the latest M&A activity and trends with CEO Shawn Titcomb of Allele Capital and Cheryl Reicin, a partner focused on international life sciences activity at Mintz.
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why Center for Biologics Evaluation and Research Director Vinay Prasad cited an unproven theory alleging politics influenced the 2020 COVID-19 vaccine emergency use authorizations to justify his decision to overrule reviewers on more recent indication updates (:35). They also consider the impact of hundreds of staff departures after the US Food and Drug Administration’s reduction-in-force was allowed to proceed, including 600 in the Center for Drug Evaluation and Research (20:14). More On These Topics From The Pink SheetPrasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/prasad-cites-unproven-theory-defending-his-covid-19-vaccine-decisions-QFAGD35QOFA5VCZS4WXDPCNWV4/ US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-center-lost-hundreds-of-staff-through-june-with-600-rifs-coming-GYSWOX6RIZEXTK5LZ4KWF3PPDY/
Join Meredith Landry, Managing Editor of Citeline’s Custom Content, in conversation with Tom Hickey, Director of Therapeutic Strategy at Novotech, a global full-service clinical CRO dedicated to accelerating the development of advanced and novel therapeutics. In this episode, recorded at the annual BIO conference in Boston, Tom offers a sharp and timely look at the state of RNA therapeutics and shares how innovation in delivery technologies, regulatory strategy, and partnership models is shaping the next generation of RNA-based medicines. With Novotech’s deep experience in the space, Tom provides actionable insights for biotech leaders looking to position their RNA programs for long-term success.
In this week's Digital Health Roundup, MedTech Insight's Marion Webb discusses her interview with Johns Hopkins researcher Axel Krieger who published study findings on autonomous surgery. Brian Bossetta highlights new FDA cybersecurity guidance and Medtronic's partnership with IRCAD to train surgeons on robots. Shubham Singh highlights his interviews with OpenWater on stroke and EnsoData on sleep. Natasha Barrow discusses FDA approval challenges with Flow Neuroscience's CEO. Tags: robotics, robotic surgery, FDA, cybersecurity, cardiology, neurology, leadership interviews, neurostimulation, commercial, medtech.
The latest episode of the In Vivo podcast features an interview Edward Ahn, CEO of Medipost, a Korean company that has developed stem cell therapies from cord blood, on how they are working across regulatory markets to provide a novel treatment for degenerative diseases.
Astellas is doubling down on gene therapy while others retreat. Richard Wilson, SVP Primary Focus Lead, Genetic Regulation at Astellas, joins In Vivo to discuss why the company believes AAV technology will transform medicine despite current industry headwinds.🎯 Key Topics:- Why Astellas opened a massive new gene therapy manufacturing facility- Building an end-to-end AAV platform from research to commercial- Strategic partnerships driving CNS and rare disease programs- Maintaining team morale in a challenging investment climate- Regulatory outlook and the path to commercial successRichard also plays a role in Astellas' West Coast Innovation Center and serves on the Alliance for Regenerative Medicine board. He shares insights on manufacturing at scale, patient-centric culture, and the long-term potential of gene therapy.Perfect for biotech investors, pharma executives, and anyone tracking the evolution of genetic medicines.🔗 More insights: insights.citeline.com/in-vivo
Audio roundup of selected biopharma industry content from Scrip over the business week ended July 11, 2025. In this episode: Merck & Co’s Verona acquisition; venture funding plummets in Q2; how Teva is expanding innovation; Apogee’s Phase II eczema win; and a look at India’s wave of licensing. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-TJX4YBGD5JDSHGRUTLYHWO2JMU/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Originally developed to treat diabetes, GLP-1 agonists have been found to suppress appetite and reduce calorie intake, fueling their growing popularity as obesity drugs. According to JP Morgan, the total number of GLP-1 users in the US may reach 30m by 2030, or around 9% of the population. But what is the opportunity for the consumer health industry? According to Kerry Group’s scientific director Mathieu Millette, there are two main areas that companies could target. Firstly, there are the pre-and post-GLP phases, when consumers may want natural GLP-1 alternatives to help them lose weight or maintain the weight loss achieved on the drug. And secondly, during use, consumer health products can help address some of the unwanted side-effects of GLP-1s, for example gastrointestinal issues. Of course, as Millette tells HBW insight in this episode of the Over the Counter podcast, marketers also need to be mindful of the regulatory environment around health claims, especially in the EU. Timestamps2:20 – Introductions3:30 – What are GLP-1 agonists?8:50 – What’s the opportunity for consumer health companies?16:00 – Is this a European trend as well?17:40 – Health claims: the regulatory environment25:00 – Natural GLP-1 alternativesGuest BioMathieu Millette is scientific director for Bio-K Plus International and RDA director for digestive health within Kerry Group’s proactive health division. Millette leads a team of talented scientists dedicated to elucidating the mechanisms of action of probiotics and to understanding the interactions between beneficial microorganisms, the gut microbiome, and the gastrointestinal tract. Millette is also associate professor at INRS-IAF, a member of the Association of Microbiologists of Quebec and is highly involved with the International Probiotic Association.
올해 제약바이오 M&A 가 다소 주춤할 것으로 전망되고 있지만, 재정난을 겪고 있는 의약품 개발업체들이 자금조달의 대안을 찾으면서 잠재적 매물이 넘쳐나고 있다는 Scrip의 BIO USA 기사를 요약한 내용입니다.https://insights.citeline.com/scrip/conferences/bio/bio-deal-trends-financial-market-stress-creates-transactional-opportunities-IL5W6U4BSZD6RPQ53EHG7HNTJ4/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
The latest episode of the In Vivo podcast features an interview with Phil L'Huillier, who discusses the inclusion of Scancell's melanoma cancer vaccine on the NHS Cancer Vaccine Launch Pad, and how 2025 could be a pivotal year for the cancer vaccine field as a whole.
Ying Tam, Chief Scientific Officer at Acuitas Therapeutics, discusses the company's role in delivering the first personalized CRISPR gene editing treatment to an infant with CPS-1, achieving treatment in just six months from diagnosis. Tam shares insights on evolving lipid nanoparticle technology beyond COVID vaccines, including LNPs that allow for next-generation immune-targeting delivery that is 10x more potent, and progress in delivering genetic medicines to stem cells and solid tumors. He also addresses the challenges of repeat dosing, a new biodegradable LNP formulation, and expanding genetic medicine beyond the liver to treat blood disorders and cancer.
The latest episode of the In Vivo podcast features an conversation with Agnès Arbat, CEO and co-founder of Barcelona-based biotech company OxoLife, which is pioneering a novel approach to addressing female infertility.
According to a recently published study by Bayer Consumer Health, being poor makes it more likely that you will suffer from self-treatable health conditions. But it also means you will find it harder to take advantage of self-care solutions. In this episode of the Over the Counter podcast, HBW Insight speaks to Bayer Consumer Health’s global medical access lead Emese Csoke about the issues that the study raises for the self-care industry, not least how widening access to self-care solutions can be balanced with equity with regards to affordability. For Csoke, ways forward include partnerships between public and private sector stakeholders and investments in digital self-care. Timestamps2:00 – Introductions2:50 – Bayer Consumer Health’s RISE initiative 4:00 – Self-care is hardest for those who need it most5:45 – Implications for the consumer health industry8:20 – Self-care’s “double burden”10:15 – Profit vs people?16:30 – Public-private partnerships19:00 – Digital self-care22:40 – Impact of RISE so farGuest BioEmese Csoke is currently serving as global strategy director for regulatory, medical, safety, quality, and compliance at Bayer Consumer Health. In this role, she plays a pivotal part in advancing health equity by designing and implementing strategic initiatives that expand access to self-care. Emese led the creation of the strategic pillar RISE – the Research Initiative for Self-care Equity – and authored a peer-reviewed publication on the impact of socioeconomic determinants on health outcomes for self-care conditions. As a lead on Bayer’s “dynamic shared ownership” model, Csoke is also driving force behind organizational transformation and innovation. Csoke holds a PharmD and a degree in Clinical Development Science from Semmelweis University and is certified as a medical science translator.
Audio roundup of selected biopharma industry content from Scrip over the business week ended July 4, 2025. In this episode: AbbVie’s big autoimmune CAR-T play; In Vivo CAR-T interest grows; China deal perspectives from BIO; global pharma interest in Korea undeterred; and a look at the biggest drug sales disappointments. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-Y77FXMFAIFEVFK75G5QUSNSBOY/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちらSnapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’（邦訳：インド、医薬品製造ネットワークの現在地 「トランプ経済政策」の最中で）https://insights.citeline.com/scrip/focus-on-asia/india/snapshot-of-indias-pharma-manufacturing-network-amid-trumponomics-4NDNAVYZW5CPZIKDIZHDRXCJ6A/※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip
How is venture philanthropy revolutionizing Alzheimer's drug discovery? We sit down with Karen Harris, CFO at the Alzheimer's Drug Discovery Foundation, to explore their game-changing approach to funding early-stage research.With $370M+ awarded to 765+ programs globally, the ADDF operates like a VC firm—using convertible debt and preferred equity to accelerate breakthrough treatments. Topics:Venture philanthropy vs traditional grantsShift from amyloid to combination therapiesBlood-based biomarkers & precision medicineNIH funding cuts impact on research ecosystemKaren brings 20+ years investment banking experience to discuss how strategic capital is changing Alzheimer's research.
In the first episode of this new China Biopharma English-language mini podcast, Shanghai-based senior reporter Xu Hu looks at the main directions in which obesity drug developers are moving, Chinese pharma firms’ position in the global race for muscle-preserving weight loss drugs and China's challenge in matching accessible drugs with well-guided weight loss.Related story links:https://insights.citeline.com/scrip/r-and-d/chinese-developers-showcase-potentially-differentiated-weight-loss-assets-at-ada-TGCGQMCVBFHS7LNTWM6YDPEC3I/;https://insights.citeline.com/in-vivo/global-vision/chinese-firms-build-obesity-clinical-pipeline-but-face-wider-hurdles-KX5GZJDC2NGKRDO6VUU7HROF4Y/
Summer Colling and Emma Wille speak with oncology experts Nkiru Ibeanu, Neha Anand, Anna Simmons and David Dahan about the 2025 American Society of Clinical Oncology (ASCO) conference. Deeper coverage is available through Datamonitor Healthcare
With growing FDA bottlenecks and regulatory changes, this episode explores how biotechs are looking beyond borders by rethinking trials, embracing real-world data, and finding new global pathways to bring therapies to life.Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights.View the video series and find out more information here: https://www.citeline.com/biotech
Audio roundup of selected biopharma industry content from Scrip over the business week ended June 27, 2025. In this episode: top drugs in the first quarter; deal trends at bio; Novo and Lilly’s obesity segmentation plans; Chinese firms at ADA; and five drugs that surpassed sales expectations. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-H57S2YTFQRBOLACVOV5SLXWK3Y/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Join Scrip editors Mandy Jackson and Mary Jo Laffler and Pink Sheet editor Sarah Karlin-Smith as they discuss the general mood at the recent BIO International Convention in Boston and around the current US economic and biopharma policy environment in general, along with other key topics at BIO including vaccines, deal and financing and the rise of China's innovation. https://insights.citeline.com/scrip/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-ID7TBPASUFG4HKFSH56TK44DUM/https://insights.citeline.com/pink-sheet/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-VGDKPJ2QQRBV5B6TY36ROPKE4Q/Time stamps(0:45) Economic and policy environment in the US(2:50) BIO leadership surprisingly open about the industry’s challenges, and willingness to call out Trump government(4:20) Most-favored nation policy proposal: storm in a teacup or existential threat(7:57) DTC sales: new opportunities to sidestep middlemen? GLP-1s leading the way(10:52) Impact of FDA staff cuts and changes on regulatory practices and policy, and on biopharma companies(16:47) Reaction of vaccine companies, health providers, insurers and other stakeholders to ACIP panel dismissal and policy uncertainty(22:27) Climate for biopharma dealmaking and financing; demand for assets(27:28) Advice for startups in challenging times(29:49) China’s biopharma industry in the ascendant(33:27) Rare diseases policy, regulation and industry focus(38:15) Priorities for BIO
The FDA’s Diversity Action Plan guidance underwent several changes in recent months—with the draft guidance taken down, restored, and then pulled again—creating uncertainty for sponsors planning Phase III and pivotal trials across all therapeutic areas. With the final guidance expected by June 26, CRO regulatory leaders reflected on how companies can manage this evolving environment. They explored:The impact of the FDA’s changing Diversity Action Plan guidance on sponsors’ trial planningHow companies adapted strategies to maintain inclusivity goals amid shifting regulatory prioritiesBroader implications for trial design, pipeline strategies, and sponsor approaches in the global drug development landscape This episode is part 2 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials.Listen to part 1 here: https://insights.citeline.com/scrip/partnered-content/podcast-series-navigating-regulatory-changes-market-dynamics-cro-perspectives-on-the-future-of-clinical-trials-26Q4Q35N6BHTZGLHIKHK6V2NXY/
The race for new therapies is more intense than ever. This episode uncovers how biotech and pharma use competitive intelligence, AI, and data to outsmart rivals and change the game.Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights.View the video series and find out more information here: https://www.citeline.com/biotech
Audio roundup of selected biopharma industry content from Scrip over the business week ended June 20, 2025. In this episode: US policies in spotlight at BIO; Lilly’s Verve acquisition; UroGen’s bladder cancer approval; Ireland’s biopharma talent; and Korea proposes new AI R&D project. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-VYWYRS37HJH6HNRZJHNGCWVSNM/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
관세와 무역 장벽의 출현, 정책 변화 등으로 올해 유럽 바이오기업들의 자금조달이 쉽지 않은 상황이라는 In Vivo 기사를 요약한 내용입니다.https://insights.citeline.com/in-vivo/market-intelligence/the-360-degrees-of-european-biotech-financing-in-2025-KZUNCOS3GZAYLBPGFTLJUBY7SY/Join Seoul-based Scrip and Pink Sheet editor Jung Won Shin in this Korean-language mini podcast on recent biopharma industry topics. Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.
The European Commission has put forward a series of proposals designed to simplify European Union sustainability rules and boost the region’s competitiveness. As a result, application dates for EU due diligence and sustainability reporting requirements have been delayed by two years. Other proposals such as reducing the frequency of reporting and narrowing the scope of supply chains are still subject to trilogue negotiation. In the first of two Over the Counter episodes, CEN Group director Jasper Crone returns to the podcast to explain what might change, where he thinks this is all coming from and why companies should consider getting ready for new sustainability reporting rules even if they are no longer directly affected. Timestamps:2:00 – Introductions4:30 – EU sustainability reporting regulation recap7:20 – Omnibus simplification package12:00 – Simplification, or confusion?19:00 – Where’s this all coming from?23:30 – Why sustainability reporting is still good for business25:40 – What’s all this got to do with competitiveness?Guest Bio:Jasper Crone is a Director at CEN-ESG, a corporate sustainability consultancy which helps businesses maximise their corporate sustainability potential, improving performance and ESG disclosure.Crone leads on several client teams, covering the implementation of internal controls and sustainability data, setting sustainability and net zero targets and developing programmes for implementation and operationalisation of objectives.He is experienced in sustainability reporting and the CEN-ESG assists clients with all aspects of sustainability reporting, whether regulatory, investor or customer driven. He brings a range of skills from 20 years of experience in the financial markets, in both the investment banking and investment management industries. He has a BSc in Biology from University of Bristol and is a CFA charter holder.You can contact Jasper via email: jasper@cen-esg.com
Audio roundup of selected biopharma industry content from Scrip over the business week ended 13 June 2025. In this episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-BC44NPMNMNGMXP5X4STR4ZAFU4/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Francesca Bruce, Senior Editor Cathy Kelly and Editor-in-Chief Nielsen Hobbs consider European officials’ opinions of President Trump’s Most Favored Nation drug pricing proposal (:29), the uncertainty the plan has created and could create for the pharmaceutical industry (22:48), as well as its potential impact on the both sides of the Atlantic Ocean (27:42).More On These Topics From The Pink Sheet‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/brainless-us-mfn-policy-could-drive-pharma-investment-to-europe-Z3FC7WBPKNF2LLG4YVZK3RBDUA/ US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany: https://insights.citeline.com/pink-sheet/geography/europe/us-most-favored-nation-pricing-could-be-game-changer-for-drug-access-in-germany-XFXD72XUSBE7VNLRMRSRQQGU5Q/ US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’: https://insights.citeline.com/pink-sheet/geography/europe/us-most-favored-nations-policy-higher-drug-spending-in-germany-is-difficult-to-imagine-QYQGDAMNH5A3HK4YWHUYFJCWME/ Could EU Collective Procurement Counter US Most Favored Nation Policy?: https://insights.citeline.com/pink-sheet/could-eu-collective-procurement-counter-us-most-favored-nation-policy-WPQOHPWQ3NF55NYDKT5KMU7AEY/ US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe: https://insights.citeline.com/pink-sheet/us-most-favored-nations-drug-pricing-policy-will-jeopardize-innovation-in-europe-TR52C5V6GVDSJBOTCEJ7T74FB4/ New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France: https://insights.citeline.com/pink-sheet/risk-sharing-agreements-greater-transparency-in-pricing-what-us-most-favored-nations-policy-could-OYEHJIF6LJCQZDL6VJHATV77JA/ Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/crisis-or-opportunity-us-mfn-policy-could-test-japans-appetite-for-reforms-3OTVRHXSOFFIJARSNHPWZ7SBJ4/
The 14 July entry deadline for the Citeline Japan Awards 2025 in Tokyo on 21 October is fast approaching! Join Ian Haydock and Lisa Takagi in this bilingual mini podcast as they outline the event and the various Award categories. (Japanese starts at 2:20.) More information on categories, entry criteria, table bookings and sponsorship opportunities here: English: https://www.citeline.com/en/awards/citelinejapanawards)Japanese: https://www.citeline.com/ja-jp/awards/citelinejapanawards)
In a tough market, biotech is racing to change the rules. This episode reveals how AI, real-world data, and strategic partnerships are reshaping drug development. Is reinvention biotech’s last hope?
In this first episode of the series, small biotech companies are facing tough times, shrinking funding and uncertain futures. But beneath the surface, quiet forces of innovation and resilience are rising. We explore how these sparks of hope might just light the way to a new breakthrough.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 June 2025. In this episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T5ID4HF465BXFGAH7C6OOSEGTA/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why seemingly routine comments from Vinay Prasad, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, that he would stay away from daily review decisions were notable (:26), as well as the impact of proposed FDA budget cuts by the White House and the House of Representatives (17:16).More On These Topics From The Pink SheetPrasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors: https://insights.citeline.com/pink-sheet/rare-diseases/prasad-says-involvement-in-us-fda-product-approvals-will-mirror-prior-cber-directors-KF4LJWX5U5DLBMSM6D4YFL7ZOA/ To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/to-compete-with-china-us-fda-must-deregulate-early-gene-therapy-studies-car-t-inventor-says-VDVXZGZIJZFHHNGGQXYILBI7RM/ FDA’s FY 2026 Budget Request Lacks New Policy Proposals: https://insights.citeline.com/pink-sheet/legislation/fdas-fy-2026-budget-request-lacks-new-policy-proposals-WV3LE2AYBRAC7LIYJEU4WZDNGU/ User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-funded-staff-would-drop-in-fy-2026-us-fda-budget-TQZMEB57V5GELNPMYGTY5BEGOY/ House Gives US FDA More Non-User Fee Funds Than Requested: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/house-gives-us-fda-more-non-user-fee-funds-than-requested-PCQZCBHOB5ARPICMJJQ6VYIJ5M/
Summer Colling speaks with Emma Wille about the symptoms, diagnosis, and treatment landscape of Sjögren’s disease, highlighting the latest research and developments.
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Flagship Pioneering senior partner Raj Panjabi discusses shifting healthcare from reactive treatment to AI-powered prediction and prevention of disease before symptoms emerge. Note: Raj Panjabi was mistakenly introduced as CEO-partner in the interview. His correct title is senior partner.
Generics Bulletin editors Dave Wallace and Dean Rudge discuss the Global Generics & Biosimilars Awards 2025, providing all the key details of the event coming up in Frankfurt this October, along with tips on how to make the most of your entries and opportunities to get more involved with the event.
Join Andrew Warmington, Manufacturing Editor at Citeline, in conversation with Tom Hickey, Director of Therapeutic Strategy at Novotech, a global full-service clinical CRO dedicated to accelerating the development of advanced and novel therapeutics.In this episode, recorded live at the European Association for the Study of the Liver Congress (EASL) in Amsterdam, Tom shares invaluable insights into the evolving landscape of hepatology clinical trials and the unique challenges and opportunities shaping the field today. Listen now to stay ahead in the dynamic world of clinical trials.
An expert from ISACA shares her insights into medtech’s Voluntary Improvement Program (VIP), a collaboration among participants, ISACA, MDIC, and US FDA formed to enhance patient safety and product quality in medical device manufacturing. Listen to learn more about attaining measurable improvements with the VIP.
Largely driven by community pharmacy footfall, France’s self-care market is dynamic and characterized by high levels of innovation, according to French self-care industry association, NèreS. As NèreS’ executive director Luc Besançon explains in this episode of HBW Insight’s Over the Counter podcast, much of this is down to the tireless work of the association. Renaming self-care products as first-line or “premier recours” (first-line) products, identifying medicines that are available OTC in other countries that could be switched in France and quantifying the impact that the revised Urban Wastewater Treatment Directive would have on access to medicines are all strands of NèreS’ pathbreaking recent work. Timestamps2:20 – Introductions3:00 – France’s self-care market7:50 – Innovation in supplements and devices11:00 – “Premiere recourse” products13:00 – Driving reclassification18:00 – Harmonising Rx-to-OTC switch across Europe20:00 – Switch environment in France26:00 – Impact of Urban Wastewater Treatment Directive in France33:00 – Who should pay?37:00 – NèreS priorities for 2025
Audio roundup of selected biopharma industry content from Scrip over the business week ended 30 May 2025. In this episode: a preview of major ASCO readouts; Roivant stays patient in deals; Lilly diversifies pain pipeline with SiteOne acquisition; Nucala gets US COPD nod; and women in Indian pharma. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-L4LQVHCXLRFEDBOU657R5SEMJY/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential comments that US Food and Drug Administration Commissioner Martin Makary and other senior agency leaders could receive during their pharma CEO listening tour (:30), as well as the impact of Health and Human Services Secretary Robert F. Kennedy Jr.’s decision to change US Centers for Disease Control and Prevention policy and no longer recommend healthy children and pregnant women receive COVID-19 vaccines (15:47).More On These Topics From The Pink SheetUS FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-makarys-pharma-ceo-tour-goes-against-transparency-rhetoric-3E5RP5IATVD73DRPQHZPSTHKRA/ HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role: https://insights.citeline.com/pink-sheet/vaccines/hhs-rescinds-covid-19-vaccine-advice-usurping-us-cdc-role-YNFI7TU5CFGERIGFG7ISOJ4X5Q/
The uncertainty surrounding changes at the FDA and other market dynamics is reshaping the global drug development landscape. In this webinar, CRO regulatory leaders will summarize the collective experience of the biotech companies we’ve spoken to recently. We will explore: •The impact of the FDA leadership changes, staffing cuts, and return to office mandates in reshaping regulatory priorities. •Trends we’re observing from biotech sponsors on the decision of whether or not to keep trials in the US. •The broader implications for industry investment, pipeline prioritization strategies, and international responses. This episode is part 1 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 23 May 2025. In this episode: Novo Nordisk’s CEO forced out; quantifying biopharma’s contribution to the US economy; a history of MASH deals; lift for AstraZeneca’s asthma ambitions; and major Japanese firms see US revenue growth. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XJZXECGBDRDJLCM6FBOJSZNPK4/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the limited label that Novavax received for its new COVID-19 vaccine Nuvaxovid, the impact of the new COVID-19 vaccine development policy announced by the US Food and Drug Administration and additional upcoming indicators of the evolving policy.More On These Topics From The Pink SheetNovavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened: https://insights.citeline.com/pink-sheet/vaccines/novavaxs-covid-19-vaccine-label-narrowed-after-political-officials-intervened-56OPC7DJ6NCXFLQYGE27SVTEH4/ Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy: https://insights.citeline.com/pink-sheet/vaccines/legal-process-problems-may-plague-new-us-fda-covid-19-vaccine-policy-HAUDHEREXZCA5DAZ47HZ6L544U/ Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says: https://insights.citeline.com/pink-sheet/vaccines/observational-retrospective-trials-could-retest-vaccines-hhs-kennedy-says-BOFKDMMHGVDNXKXMFEILOXAH4E/ US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems: https://insights.citeline.com/pink-sheet/vaccines/us-fda-covid-19-booster-strategy-may-not-be-as-controversial-as-it-seems-ZEAHMHE5LJB6HLBT2WRZW4L3AY/ US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-punts-on-new-covid-19-frameworks-impact-on-fall-shots-QSB6OPEB4ZCEFLS36JG3Y7XSPE/
Mikkel Wandahl Pederson, CEO and chief scientific officer at Commit Biologics, discussed the company’s mission to harness the powerful complement system for the treatment of serious diseases.
바이오기업 가치상승으로 일부 딜 (deal)의 경우 빅파마의 투자수익률 (ROI)이 거의 없는 상황이지만, 특정 전략으로 성공 가능성을 높일 수 있다는 Scrip 기사를 요약한 내용입니다.https://insights.citeline.com/scrip/business/deals/biopharma-deals-roi-has-fallen-and-market-instability-could-make-it-worse-MV7Z55MUW5EB7CWVF6JYKHZWUA/Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
While few doubt the opportunity represented by real-world evidence, some concerns remain about its validity compared to traditional forms of clinical evidence, particularly among regulators. To address these concerns, IQVIA Consumer Health’s vice president of global research and development and real-world evidence services, Volker Spitzer, suggests that incorporating some elements of traditional trials, such as randomization, is a good way to persuade regulators that RWE can be used for consumer health innovation, for example in generating new claims or supporting Rx-to-OTC switch. Looking forward, Spitzer is excited about the ways in which digital health tools and artificial intelligence can be used to expand the scope of RWE as well as drive personalization for consumers. Timestamps:3:00 - Addressing concerns about RWE’s scientific rigour and validity12:00 – Regulators’ views of RWE, particularly for consumer health16:00 – Use of RWE for Rx-to-OTC switch22:00 – The future of RWEGuest Bio:Volker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer.Since October 2017, Spitzer has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 16 May 2025. In this episode: Trump’s executive order more rhetoric than action; industry grapples with Trump pricing plan; Hengrui set for this year’s biggest IPO; Sanofi’s exec’s advice to biotechs; and biotech deal return on investment falls. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4WWGRDN7VB3BB2KULQYTQFKJM/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
在本期中国生物技术播客中，Dexter Yan回顾了他在4月的美国癌症研究协会年会（AACR）举办前和再鼎医药总裁及全球肿瘤研发负责人Rafael Amado的采访。Amado在采访中详细阐述再鼎在AACR展示的两个临床前项目，分别是PD-1/IL-12 双抗和靶向LRRC15的抗体偶联药物（ADC）。Dexter还采访到Arbele的创始人和CEO John Luk，请他介绍Arbele在钙粘蛋白17（CDH17）靶点研发上的最新进展和心得体会。最后Dexter回顾了4月维升药业和映恩生物在香港交易所首次上市的情况。此外，Xu Hu分享了她最近撰写的有关中国企业研发肠促胰岛素类体重管理药物的综述。除此之外，Xu点评了中国药监局最近公布的有关药品试验数据保护的征求意见稿。
Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 May 2025. In this episode: industry makes its case to Trump; Sarepta slammed by double blow; Chinese firms build obesity pipeline; Swiss biopharma staying strong; and Merck & Co looks to immunology and ophthalmology. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HVFSXCWENFCU7FLRVPHK3P4WFU/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider early excitement and concern about Vinay Prasad’s potential impact on product development as director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (:20). They also consider the consequences of the FDA missing product-specific guidance publication deadlines (14:59) and its potential impact on the upcoming user fee reauthorization negotiations (20:00).More On These Topics From The Pink SheetTougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tougher-approval-standards-may-follow-vinay-prasads-appointment-to-lead-us-fdas-cber-WEULXI5EJRE43BWU752PGDGE44/ US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-guidance-roadblock-writing-continues-but-publication-has-slowed-or-stopped-TZF4DMPEMVHT3JJPRUX7LJJIHU/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 May 2025. In this episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data.https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LV7ZA2GKQVHEZDZYYNZFKYQZ74/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
The potential for real world evidence (RWE) is huge, according to enthusiasts, but to the uninitiated it can seem like a complicated and forbidding subject. In this Over the Counter double episode, IQVIA Consumer Health’s vice president of global research and development and real-world evidence services, Volker Spitzer, makes understanding real world evidence easy. We start with the basics, with what it is and what companies need to know about it, and what the key difference is with randomised control trials. Many companies are already using real world evidence, Volker notes, and he extracts some key lessons for companies interested in trying it out based on his extensive experience working with industry on such projects.Timestamps2:00 – Introductions4:00 – What is real world evidence?5:00 – Can RWE and clinical trials complement each other?10:00 – Why RWE is particularly attractive today14:00 – Don’t reinvent the wheel18:00 – Why is this important for consumer health companies?25:00 – Why RWE is often a good value option, especially for SMEs33:00 – Applications of RWE in consumer healthGuest BioVolker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer. Since October 2017, Volker has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.
Anil Matai, director general, Organization of Pharmaceutical Producers of India, discusses the evolving intellectual property landscape in India post the 2024 amendments and long-standing sticking points including Section 3(d) of India’s patent regulations and regulatory data protection. Big pharma’s experience when it comes to the Bolar provision and the impact of geopolitical shifts on innovation were some of the other topics he touched on.
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider the impact of FDA Commissioner Martin Makary directing one of his assistants to take over the review of Novavax’s COVID-19 vaccine (:40), as well as how states or courts could respond (19:19). They also discuss several announcements of missed user fee deadlines and whether FDA layoffs could have contributed (28:33).More On These Topics From The Pink SheetUpdated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review: https://insights.citeline.com/pink-sheet/vaccines/political-official-pushing-novavax-to-conduct-covid-19-vaccine-postmarket-rct-BZTIWKSTK5G77BUQGGD3G2IOFY/ How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch: https://insights.citeline.com/pink-sheet/vaccines/how-states-and-courts-could-insulate-america-from-an-anti-vaccine-executive-branch-DARDVWDMLVFCHM6DE75AJQHSBQ/ US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioners-office-plans-involvement-in-many-approvals-in-potential-major-change-JFPWOQ2VF5D2JAFKXKGK54REZU/ US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts: https://insights.citeline.com/pink-sheet/product-reviews/us-fda-miss-on-stealths-elamipretide-boosts-signal-of-broader-delays-due-to-staff-cuts-5ITZREGXX5H75ID6IL4Q2MHKBE/
Scrip senior writer Joseph Haas discusses the potential impact of the recent FDA staff cuts with attorneys Andrew Goodman of Paul Hastings LLP and Alan Minsk of Arnall Golden Gregory, as well as Naya Therapeutics CEO Daniel Teper
In this episode, we recap the key takeaways from BIO-Europe 2025, held in Milan, Italy, in March 2025, with Trajko Spasenovski, Vice President of Strategic Account Management at Evaluate, and Carolyn Hall, Senior Director of Content and Thought Leadership Marketing at Evaluate. After the conference, Citeline’s Managing Editor, Meredith Landry, spoke with them about their experience there and what they learned about trends in early-stage deal-making, emerging areas like cardiovascular and rare disease therapies, and the expanding role of AI in R&D. Trajko and Carolyn also shared how conferences like BIO-Europe help Norstella and its clients forge meaningful partnerships, uncover market needs, and accelerate the path to life-saving therapies through data-driven insights and strategic collaboration.
Emma Wille and Summer Colling discuss the 2025 American Academy of Neurology (AAN) conference with CNS and I&I analysts Wen-Yu Huang, Joseph Jacob and Istafa Armughan.
Aragen Life Sciences’s CEO Manni Kantipudi - also former CIO of Intel Asia - speaks with Citeline’s senior editor Vibha Ravi about the changing global supply chain dynamics as the industry watches a ticking time bomb of US tariffs on pharmaceuticals. Impacts on Indian CRDMOs of the US-China trade war, budget cuts at US NIH and lower funding for biotechs are discussed.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 25 April 2025. In this episode: 2024’s top-selling drugs; two CEOs call for higher Europe drug prices; diabetes trial win for Lilly’s orforglipron; BMS trial failure in schizophrenia; and an analysis of alliance deal-making last year.https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-6L5MDUXZ5BGHJHLZFILGLH6ZT4/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of the departures of several senior leaders in the US Food and Drug Administration’s facility inspection group, Office of Generic Drugs and Office of Prescription Drug Promotion (:26). They also consider Commissioner Martin Makary’s intent to combine the agency’s many adverse event databases (14:52), his idea for a new approval pathway based on a “plausible mechanism” (26:25) and the seemingly increasing influence of politics at the agency despite his declarations that the FDA is apolitical (36:16).More On These Topics From The Pink SheetUS FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-retirements-continue-unabated-with-drug-inspectorate-leaders-former-chief-counsel-JRKHCHZHMBC4RLRJRBDTSIP7E4/ FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-leadership-shuffle-continues-lowell-zeta-returns-as-opdp-ogd-leaders-depart-FONMRWR37VGAFL2JJ5S27QIU2E/ US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/us-fdas-makary-floats-vague-plausible-mechanism-approval-pathway-for-rare-diseases-RJJJCPDUDFHINMPDE5VK4OFDVQ/ US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-makary-wants-to-combine-adverse-event-reporting-systems-UJ4QUEM72ZC25J7JHAC3LAKKKA/ Political Influence And The US FDA: A New Era?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/political-influence-and-the-us-fda-a-new-era-SL6ZBNKHNVFEXCLQLCYTDJIETQ/
Ochre Bio co-founder and CSO Quin Wills spoke with In Vivo about the UK-based company's novel approach to finding and validating RNA therapies for chronic liver diseases.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 18 April 2025. In this episode: Trump’s drug pricing executive order; J&J says taxes, not tariffs, influence US manufacturing; Pfizer discontinuation sparks M&A speculation; US tariffs and manufacturing concentration; and tariffs’ pressures on pharma’s complex supply chain. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ROAXNELATJBXDMNSHISARWARPY/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Summary:At the heart of any successful self-care business is a portfolio of recognizable and trusted consumer health brands. These brands could play a key role in unlocking the potential of digital self-care in the UK, suggests Michelle Riddalls, in this second part of her Over the Counter interview. As PAGB CEO, Michelle has seen first had how the UK consumer health industry has been transformed, for example also by Brexit. Has the UK’s exit from the EU realised the promises of innovation unleashed from bureaucracy? Not so far, Michelle reflects, but it might be too soon to tell. What she can predict is that with its new five-year strategy, PAGB will remain dedicated to supporting UK firms in navigating a continuously evolving industry landscape. Timestamps2:00 – Digital consumer health in the UK7:00 – The power of brands12:00 – Brexit, promise realised? 20:00 – What’s next for the UK OTC industry?Guest BioMichelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK.Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 11 April 2025. In this episode: Trump’s tariff rollercoaster; regulatory, economic uncertainties hang over Q1 earnings; IPOs rise in Q1 but may slow; Chinese deal-making matures; and AstraZeneca talks about Chinese innovation. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-X3YNW3ZLVZABLNFILQHNH6FPAE/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
미국이 수입 의약품에 관세를 부과할 가능성은 여전하지만, 트럼프의 최근 발표로 인해 이를 시행하는 데 시간이 더 걸릴 수 있다는 Pink Sheet (Citeline Regulatory) 기사를 요약한 내용입니다.https://insights.citeline.com/pink-sheet/compliance/distribution-supply-chain/pharma-still-nervous-while-riding-trumps-tariff-rollercoaster-DFQMWLGXSZBS3K34UY2OE6TUVA/Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
Exerting maximum influence on stakeholders, helping companies navigate regulatory complexity and promoting industry best practice are three big jobs that the UK consumer healthcare industry association, PAGB, has set itself for the next five years. In the last five years, PAGB has made significant headway with UK government, reports PAGB CEO Michelle Riddalls, establishing the economic and social value of self-care and ensuring that self-care is part of the UK’s national healthcare strategy. Rx-to-OTC switch has been a major area of success, Michelle notes in this episode of the Over the Counter podcast. The Department of Health and Social Care recently published a list of switches it would like to see applications for, and PAGB is now facilitating members to take advantage of this opportunity. But there’s always more work to be done. Switch involves significant risk, which PAGB is trying to reduce through further work with policy makers, and with a new government, the association must ensure that self-care remains high up on the agenda for politicians. Given the breadth of PAGB’s work discussed by Michelle, we have split this episode into two, so watch out for the second part in two weeks’ time on your favourite podcast provider and on Citeline’s HBW Insight. Timestamps2:10 – Introductions2:40 – PAGB’s new five-year strategy5:40 – Evolution not revolution8:00 – Self-care and UK government policy10:30 – Quantifying the value of self-care12:30 – Lobbying around AMR and OTCs16:00 – Rx-to-OTC switch in the UK24:00 – The power of brandsGuest BioMichelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK.Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 4 April 2025. In this episode: pharma dodges tariffs for now; Marks’s departure from FDA rattles industry; Phase 2b win for AstraZeneca’s oral PCSK9; Hengrui renews global Phase 3 push; and Novo’s new cardio results for semaglutide. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MPJF4YP4NFAQ5JEDFBEIW62LBE/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the impact of the 1 April reduction-in-force on the US Food and Drug Administration, which targeted about 3,500 employees (:30). They also consider how and whether service levels will change (13:28), and new Commissioner Martin Makary’s first address to the drastically smaller staff the day after the RIF was announced (29:22).More On These Topics From The Pink SheetUpdated: US Likely To Lose Its First Approver Advantage After FDA Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-layoffs-us-likely-to-lose-its-first-approver-advantage-5C37YQ73DNBEFF7SHRYV4MJUIA/ Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/are-bigger-ad-policy-changes-coming-after-us-fdas-drug-promotion-office-hit-hard-by-layoffs-FQLHKJ4GWRCXLEIZCEMX37SUYU/ Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dramatic-hhs-layoffs-a-response-to-existential-crisis-kennedy-advisor-argues-XZKO5PJF6RHGHLABD2TZY7K2N4/ CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cdrh-staff-cuts-focus-on-administrative-workers-spare-reviewers-DL3L63CAGFGYTDAICFSXG5JP34/ Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-pledges-to-uphold-gold-standard-science-but-first-address-confuses-some-us-fda-staff-WE7A5TQARBHX3MS6LGDIQT5CRY/US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-restructuring-may-be-next-after-drugs-center-loses-more-than-1000-people-HOZ7IYGEC5BYBMNNUPAT2TBNI4/
OSE Immunotherapeutics' CEO Nicolas Poirier talks about the company's IL-7 receptor agonist, lusvertikimab, recent data presented at The European Crohn's and Colitis Organization congress, commercialization and development strategy and the future of IBD therapy.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Gary Guthart, CEO of Intuitive Surgical about the new da Vinci 5 surgical robot and the future of robotics in surgery. Brian Bossetta talks about the recently FDA-cleared patient monitoring system that sends vital signs directly to clinician staff. Elizabeth Orr discusses an FDA warning letter to Exer Labs and Shubham Singh discusses Roche’s new NGS Prototype, expected to challenge Illumina.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 March 2025. In this episode: Merck & Co. licenses Hengrui’s lipid lowerer; Novo gets United’s triple G obesity drug; J&J plans major US manufacturing investments; approval for GSK’s novel antibiotic; and a call for more aggressive Korean M&A activity. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-7API33OTGJELXGC7RGOH2KK2G4/This episode was produced with the help of AI text-to-voice and voice emulation tools.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Senior Editor Sue Sutter discuss the impact of the 3,500 layoffs on the US Food and Drug Administration, including the areas where the agency could lose some autonomy (:28). They also consider worries that the agency’s preparations for user fee reauthorization negotiations may be slowing because of the upcoming staffing cuts (24:09).More On These Topics From The Pink SheetPower Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/power-play-us-fda-likely-losing-more-than-just-staff-with-restructured-health-department-BT5YZ4U7WNANBEZN7OBF42LCEE/ US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-staffing-uncertainty-could-impact-upcoming-user-fee-negotiations-EAUTZOANHVB3PK6NKCLJCYTOLA/ Can New US FDA Commissioner Makary Calm Agency During Turbulent Times?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/can-new-us-fda-commissioner-makary-calm-agency-during-turbulent-times-STBAXTWCIFEGJPDYZ6LZKMRPE4/
In Vivo spoke with UK biotech CEO Catherine Pickering about developing innovative therapies for challenging cancer types, the progress of iOntura's lead asset, roginolisib, for uveal melanoma, and the strategies that have helped secure over €100m in private financing.
Farideh Bischoff, chief medical officer of Heranova Lifesciences, discusses the urgent need for better diagnostic options and the latest innovations transforming care for endometriosis patients.
Europe’s self-care industry leaders, policymakers and stakeholders are heading to Warsaw, Poland between the 4th and 6th June this year for the Association of the European Self-Care Industry’s 61st Annual Meeting. With Poland heading up the EU Council and the country being one of the largest and most self-care friendly markets in Europe, the location made sense, explains AESGP director general Jurate Švarcaite, in this episode of Over the Counter. As always, there’s a jam-packed line up for the event, which every year sets the agenda for industry in the months to come. Highlights for Jurate include sessions on the role of prevention in self-care and the competitiveness of European industry on the world stage.I’m personally also looking forward to discussions about how industry will square the circle of sustainability, with medicines posing unique challenges for both regulators and manufacturers. Sign up for AESGP’s 61st Annual Meeting: https://aesgp.eu/events/61st-aesgp-annual-meeting
Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 March 2025. In this episode: Pfizer tops pharma leaderboard; AstraZeneca buys into in vivo cell therapy; Almirall looks to dominate derma spectrum; Incyte’s HS contender looks approvable; and MSD’s Williams says pharma should shorten tech adoption cycles. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EGD3MLOIVJDKRCE32KV376CJ5Q/This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss industry stakeholders’ complaints about US Food and Drug Administration productivity declines in the weeks since President Trump took office and began making changes and the potential recourse for industry (:24). They also review the expected and emerging problems with the agency requiring nearly all of its Washington, D.C.-area staff to return to in-office work at its White Oak headquarters and consider its impact on workflow going forward (15:35).More On These Topics From The Pink SheetUS FDA’s Speed Of Work Under Trump Quietly Raising Industry Concerns: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-speed-of-work-under-trump-quietly-raising-industry-concerns-ZWM522FIDJAO7DVAJYZRLLDFAI/ US FDA Survives First Day Of Return To In-Office Work, But True Test Upcoming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-survives-first-day-of-return-to-in-office-work-but-true-test-upcoming-AZOWC5ITNNGGVG3TIGGWR5VMBA/ Cramped Quarters, Limited Parking And Water Concerns Await US FDA’s Return To Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cramped-quarters-limited-parking-and-water-concerns-await-us-fdas-return-to-office-YWHJRM6RTZF4NJP2MZX4Y6LLQA/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 March 2025. In this episode: Roche’s big new obesity deal; J&J opts out of next-gen Darzalex; Arvinas and Pfizer’s protein degrader misses Phase III endpoint; Kelun wins first TROP2 ADC approval in lung cancer; and big name brands poised to lose US exclusivity. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-QOIAKBVZ2FDQ7NL2SFMWK66HP4/This episode was produced using AI text-to-voice and voice emulation software. Let me know your views: ian.haydock@citeline.com.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration’s early retirement and buyout programs to further cut its workforce (:25), leadership departures in the Center for Biologics Evaluation and Research (9:13), the quick arrival and resignation of a new FDA chief counsel (12:35), and Commissioner nominee Martin Makary closing in on confirmation, as well as the impact of the staffing changes on the agency he likely will be running (22:45).More On These Topics From The Pink SheetUS FDA Reviewers, Inspectors Not Eligible For HHS Buyouts: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-reviewers-inspectors-not-eligible-for-hhs-buyouts-PHAPCCR7NZBCRKRL6NPQANGGW4/ User Fee Deadline Concerns Emerge As US FDA Buyout Offer Sweetened With Paid Leave: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-deadline-concerns-emerge-as-us-fda-buyout-offer-sweetened-with-paid-leave-WRCP4JYKTJHZPP3QTLGJQPTS54/ CBER Losing Cell, Gene Therapy Leadership As Workforce Culling Continues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cber-losing-cell-gene-therapy-leadership-as-workforce-culling-continues-CAWLALTKUVFADETC7HZEXMJQKA/ US FDA May Lose Some Autonomy Under Health Department’s General Counsel Reorg: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-may-lose-some-autonomy-under-health-departments-general-counsel-reorg-VUS3GIMCLBE2TC2BUL7UHMIEP4/ Makary US FDA Nomination Advances, Last Minute Hiccup May Offer Clues On Mifepristone: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-us-fda-nomination-advances-last-minute-hiccup-may-offer-clues-on-mifepristone-XQXLBN7HRNGUPCNV3XEUHR3ASA/ Don’t Ask, Don’t Tell: Senate Democrats Ready To Embrace Makary Heading US FDA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dont-ask-dont-tell-senate-democrats-ready-to-embrace-makary-heading-us-fda-AOZR6OAM5RHF5ECCOYGQPV77HQ/
Scrip senior writer Joseph Haas discusses the latest biopharmaceutical merger-and-acquisition activity and trends with attorneys Jessica Bisignano and Gabrielle Witt of Hogan Lovells.
Summer Colling and Emma Wille speak with Datamonitor Healthcare's infectious disease analysts Charlotte Holmes and Natasha Boliter to discuss the latest trends in COVID-19 and influenza, including their global impact, vaccine developments, and the challenges in prevention. The experts break down the science behind these viruses, the future of combination vaccines, and what’s next for respiratory disease prevention.
Generics Bulletin editors Dave Wallace and Dean Rudge discuss the latest updates on Stelara (ustekinumab) biosimilars in the US, including recent launches, pricing strategies, and parallels with the biosimilar Humira (adalimumab) experience.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 7 March 2025. In this episode: low-cost Wegovy an alternative for US self-payers; Bayer rolls up sleeves for turnaround; taking the pulse of NewCo creation; the outlook for Alzheimer’s; and India’s rare disease landscape. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HRMLFN6ZKBHU5KRWSZLLCL3VYY/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-thingsRelease date:3 March 2025
Summary: The UK’s Maxwellia has been on quite a journey, from “switch-in-a-box” start-up to a consumer healthcare company in its own right, launching some of the most innovative products on the way. Specialising so far in women’s health, with OTC brands ranging from the first-in-class daily contraceptive pill to much needed menstrual health solutions, Maxwellia CEO Anna Maxwell now has her eye on a recently published list of Rx-to-OTC switched the UK government would like to see applications for. To realise these switches, Maxwell calls for the government to make it easier for smaller companies like Maxwellia to access all important funding. Timeline2:00 – Introductions3:00 – Maxwellia’s growth journey11:00 – Innovating in women’s health20:00 – Room for growth in the women’s health category21:00 – UK government’s Rx-to-OTC switch wishlist25:00 – The advantages of being a small company27:00 – Beyond women’s health30:00 – The disadvantages of being a large company31:20 – Maxwellia’s immediate futureGuest BioAnna Maxwell is a pioneering pharmacist and healthcare entrepreneur reshaping public health by making essential medicines more accessible. As founder and CEO of Maxwellia, she’s driving growth with strong retail partnerships, a robust innovation pipeline, and plans for international expansion.With a clear vision and relentless drive for innovation, Maxwell is leading a movement to give people more control over their health – “because the future of self-care is here, and Maxwellia is making it happen.”
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the issues that dominated the Senate confirmation hearing for US Food and Drug Administration Commissioner nominee Martin Makary, including vaccines (1:03) and mifepristone (14:45), as well as several questions that were not asked (23:31). They also consider the potential impact of his answers on the agency.More On These Topics From The Pink SheetMakary Plans To Review Mifepristone Data, Raising Concerns Of Abortion Pill Access Rollbacks: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-plans-to-review-mifepristone-data-raising-concerns-of-abortion-pill-access-rollbacks-24NTRIXLKJD23OKNBB5Z7UAFL4/ Senators Scrutinize US FDA Commissioner Nominee Makary Over VRBPAC Cancellation: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/senators-scrutinize-us-fda-commissioner-nominee-makary-over-vrbpac-cancellation-HVW5VNH55ZFUPBL64BK2VNOYJA/ Science Vs. Politics: Hearing Could Reveal Makary’s Approach To Unusual Administration Involvement: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/science-vs-politics-hearing-could-reveal-makarys-approach-to-unusual-administration-involvement-LGWBJEWWNRCIXPVEJ4AEAJRLN4/
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「As Trumps Ups The Ante On Tariffs, Reactions Are Mixed（邦訳：止まらぬトランプ関税措置 業界の反応は複雑化）」URL: https://insights.citeline.com/scrip/business/manufacturing/as-trumps-ups-the-ante-on-tariffs-reactions-are-mixed-7WMIGZ3O5JHF7AJSICVLRUE3GY/※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip
In Vivo spoke with Tran Le and Sohit Gatiganti, co-founders of Grove AI and developers of Grace, a voice-based agentic AI that streamlines clinical trial processes.
트럼프의 관세 조치에 따른 미국시장 영향과 글로벌 빅파마들의 반응에 대한 Scrip 기사를 요약한 내용입니다.https://insights.citeline.com/scrip/business/manufacturing/as-trumps-ups-the-ante-on-tariffs-reactions-are-mixed-7WMIGZ3O5JHF7AJSICVLRUE3GY/Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
The consumer healthcare industry is changing. Companies are separating from their pharmaceutical parents and brands are shifting from therapeutic solutions to preventative health and wellness options. These shifts bring a number of challenges for OTC firms, notes AdverCheck managing director James Walmsley in the second part of his chat with HBW. For example, it is much more difficult to get science-backed claims for food supplements approved, he points out. With firms now also becoming standalone consumer health entities, there is no longer a direct pipeline of off-patent prescription medicines available for Rx-to-OTC switch, he observes. We may, therefore, see a new generation of switch-focused self-care companies and partnerships emerging.Keywords: Innovation, AdverCheck, OTC medicines, Consumer Health, Rx-to-OTC switchTimeline
Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 February 2025. In this episode: which big companies face the least LOE hit?; IPOs rise in 2024; Pfizer cuts last AAV gene therapy program; balance and focus suggested for globalizing Chinese firms; and Scrip Asks on therapeutic area advances. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-4RXPQH4B5NBJ3AM7SFMPROUJ2U/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr, discuss the US Food and Drug Administration’s decision to call back many workers that were laid off and the next steps for the Trump Administration’s effort to reduce the size of the federal government (:29), the FDA decision to cancel an upcoming Vaccines and Related Biological Products Advisory Committee meeting on strain selection for the 2025-2026 flu vaccine (12:42), and the motives for Eli Lilly’s plan to increase domestic manufacturing (23:18).More On These Topics From The Pink SheetDrug Reviewers And Legal Staff Among Those Called Back to US FDA, But Why?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/drug-reviewers-and-legal-staff-among-those-called-back-to-us-fda-but-why-YWONQYDHARESFLLY26YEP6RIHI/ DOGE-ing US FDA: Three Scenarios For What Comes Next: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/doge-ing-us-fda-three-scenarios-for-what-comes-next-XUDLPX3WNNH55JCHOMTOS2NXBA/ Breaking: US FDA Cancels Upcoming Adcomm Discussing 2025-2026 Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/breaking-us-fda-cancels-upcoming-adcomm-discussing-2025-2026-flu-vaccine-AGBZQHYGZFHZLOK2PU5CCKBNK4/ Lilly $27Bn US Manufacturing Investment Linked To Trump’s Tariff, Tax Agenda: https://insights.citeline.com/pink-sheet/compliance/manufacturing/lilly-27bn-us-manufacturing-investment-linked-to-trumps-tariff-tax-agenda-FN55MQ3V75EU5J42TIYTFLTH4Q/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 February 2025. In this episode: 2025’S biggest launches; 2024 deal metrics declined; GSK’s meningococcal vaccine; Arcus’s kidney cancer results; and Novartis on its India hub. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-2Y543BULOJEOTHMZLB5ATXRVPU/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
UK law prohibits the advertising of prescription-only medicines. Nevertheless, some online pharmacies are marketing Rx drugs from “skinny jabs” to high strength eczema treatments, essentially selling prescription medicines directly to consumers, explains AdverCheck managing director James Walmsley. While regulators are cracking down on illegal practices, the growing market for prescription medicines is increasingly impinging on traditional consumer healthcare categories, Walmsley warns. In this episode of Over the Counter, we get to the bottom of this fascinating issue and outline what firms need to know.
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr and HBW Insight Managing Editor Malcolm Spicer, discuss the most up-to-date information on the layoffs at the US Food and Drug Administration that were instituted by the Trump Administration (:42). They also consider the layoffs’ impact on the drug, device and consumer health divisions, including application review and facility inspections, as well as industry’s response to them (17:58). More On These Topics From The Pink SheetUS FDA Staff Cuts: Biopharma Industry Braces For Impact, But First Wants Clarity On Losses: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-staff-cuts-biopharma-industry-braces-for-impact-but-first-wants-clarity-on-losses-C45JIJX7IRD5FON2BNNKHTTBZU/ CMS Layoffs Broader Than Reports Indicate, Former Administrator Brooks-LaSure Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/cms-layoffs-broader-than-reports-indicate-former-administrator-brooks-lasure-says-A6XEKATFPRFXZCHSD7VDKO53HA/ Weekend US FDA Layoffs Cost Device Center Many AI And Digital Health Staffers: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/weekend-us-fda-purge-costs-device-center-many-ai-and-digital-health-staffers-VSCWD67JAJARTP7S3EZYB6KSIQ/ US FDA Food Safety Leader Resigns In Protest Of White House-Ordered Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-food-safety-leader-resigns-in-protest-of-white-house-ordered-layoffs-ZJSIV3VWTNBB7MPGPOV7TUWWJU/ FDA Cosmetics Office Braces For Agency-Wide Staff Cuts; MoCRA Implementation Likely Delayed: https://insights.citeline.com/hbw-insight/beauty/policy-and-regulation/fda-cosmetics-office-braces-for-agency-wide-staff-cuts-mocra-implementation-likely-delayed-5CNPONAL2JBGRIOVLTPSISLCFY/ PhRMA Still All In For Trump Despite Chaos Hitting US Health Sector: https://insights.citeline.com/pink-sheet/market-access/phrma-still-all-in-for-trump-despite-chaos-hitting-us-health-sector-MSNPGI66H5AABGVJVGG2MLNZIA/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 February 2025. In this episode: delayed take-off for M&A?; Bain to acquire Mitsubishi Tanabe; clinical trials to look out for; how to work with Trump; and mid-cap biopharma winners and losers. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-PYWFIZWE2FH2LIZUT4BDHGBZHQ/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs, and special guest Michael McCaughan of Prevision Policy look at new Health and Human Services Secretary Robert F. Kennedy Jr.’s first assignment, a presidential commission on reducing chronic disease (:29), as well as former US Food and Drug Administration Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee program rather than negotiate a new agreement in the current political environment (13:30). They also discuss the impact of President Trump’s executive order mandating a reduction in force across the federal government on the US Food and Drug Administration and communications questions affecting the agency’s advisory committee schedule (25:16).More On These Topics From The Pink SheetCommission Led By HHS Secretary Kennedy Will Probe ‘Threats’ To Children, Including Medicines: https://insights.citeline.com/pink-sheet/agency-leadership/commission-led-by-hhs-secretary-kennedy-will-probe-threats-to-children-including-medicines-Q5YF65T23JEOXDWQ7I72X556KQ/ Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step: https://insights.citeline.com/pink-sheet/agency-leadership/bracing-for-rfk-at-hhs-vaccine-safety-commission-likely-first-step-O5XKOSVYYVE7RMQUAIHZ4I2OLY/ User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/user-fees-industry-should-push-for-extension-of-current-agreement-in-reconciliation-bill-gottlieb-says-YOWZW2CMSZA4BDP23MR2FLQJB4/ Could PDUFA VIII Align With Trump’s Efficiency Emphasis?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/could-pdufa-viii-align-with-trumps-efficiency-emphasis-5WGLRU6N2FG4XABILEMHBYDXYI/ US FDA Advisory Committee Freeze Raises Concerns Of Delayed, More Controversial Approvals: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-freeze-raises-concerns-of-delayed-more-controversial-approvals-CWT2HOAQ3JBHNCMKSSOOXVAYYU/ ‘This Is Not Good For Business’: Trump’s Workforce Shakeups Could Harm Industry: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/this-is-not-good-for-business-trumps-workforce-shakeups-could-harm-industry-JJTMQ5RXOFDC7DQDVIZ3S2NJG4/
Citeline’s expert panel of reporters and analysts unpack the biggest deals, trends, and innovations from the JP Morgan Healthcare Conference. Discover what these developments mean for you and the future of the industry in 2025 and beyond.
트럼프 미 대통령의 재당선과 지정학적 불안요소가 제약바이오 시장과 기업에 어떤 영향을 미칠까? Scrip의 전문가 설문조사 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/scrip-asks/scrip-asks-what-does-2025-hold-for-biopharma-part-3-impacts-of-political-change-in-us-and-beyond-CKTDR3BC2JBU5O6MUHDAKXGXHU/Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
Audio roundup of selected biopharma industry content from Scrip over the business week ended 7 February 2025. In this episode: Novo outlines CagriSema strategy; Pfizer is back in the deal game; Vertex’s pain drug faces opportunities and headwinds; uncertain times for Korean pharma; and a view on women’s health at JPM.https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-Y37SM5W2TZDXNE26O3W6E33TZE/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Creativity can sometimes be about discovering what in retrospect seems obvious, like shoes that are shaped to fit our feet, marketing expert Beverley Law tells HBW Insight in the first episode of this season’s Over the Counter podcast. But this often requires stepping out of established approaches and patterns of thinking, she points out, which tend to characterise innovation in the consumer health industry. Law offers some tips to help firms think outside the box, including being brave, benchmarking against the fast-moving consumer goods industry, and including regulatory experts much earlier on in the process.
Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the many commitments Robert F. Kennedy Jr. gave Sen. Bill Cassidy, R-LA, to secure his vote to move his Health and Human Services Secretary nomination to the Senate floor (:25). They also consider the slow restoration of some US Food and Drug Administration public communications and the impact of HHS postponing activities not deemed “mission-critical” (10:36).More On These Topics From The Pink SheetHHS Nominee Kennedy’s Behind-The-Scenes Vaccine Reassurances Win Senate Swing Vote: https://insights.citeline.com/pink-sheet/vaccines/hhs-nominee-kennedys-behind-the-scenes-vaccine-reassurances-win-senate-swing-vote-F45HDCJQJJDIDKJOFXYODP6DJQ/ Kennedy Would Issue Trial Diversity Guidance, But Not Necessarily Roll Back All Anti-DEI Actions: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/kennedy-would-issue-trial-diversity-guidance-but-not-necessarily-roll-back-all-anti-dei-actions-4SDSMJ5V7NFPHKVUX5XYBMRMEE/ FDA Communications In Flux As HHS Assesses Mission-Critical Activities: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-communications-in-flux-as-hhs-assesses-mission-critical-activities-H5UQ7BRSSZBVJDJBAXSVTDLIR4/ As US FDA Communications Freeze Thaws, Approvals Accumulate: https://insights.citeline.com/pink-sheet/product-reviews/approvals/as-us-fda-communications-freeze-thaws-approvals-accumulate-JA4WVLHMGJEZDHYB7LRNZAOYT4/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 31 January 2025. In this episode: biopharma VC fundraising recovers; Daiichi Sankyo’s big year ahead; Akero’s promising MASH results; ADCs attract new investments in China; and Scrip Asks on AI and data science. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D3ODXZGPURHZFJKT7MTVZ3AUWI/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-thingsRelease date:27 January 2025
Harness Therapeutics' CEO talked to In Vivo about the company's scientific strategy, and its plans for expansion and partnering in the neurodegeneration space.
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the effect of Acting US Food and Drug Administration Commissioner Sara Brenner’s use of MAHA in her introductory memo (:35), the issues that emerged during MAHA founder and Health and Human Services Secretary nominee Robert F. Kennedy Jr.’s Senate confirmation hearings (7:22), return to office plans for senior FDA staff (14:27), and postponed meetings and other impacts of the Trump Administration’s freeze on agency communications (19:30).More On These Topics From The Pink SheetUS FDA Acting Commissioner Tells Staff She’s Ready To MAHA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-acting-commissioner-tells-staff-shes-ready-to-maha-D3VJ2JORKVEC5MKJNBRNY2XAOE/ Beyond Vaccines: Kennedy’s Anti-Pharma Side On Display At Senate Hearings: https://insights.citeline.com/pink-sheet/agency-leadership/beyond-vaccines-kennedys-anti-pharma-side-on-display-at-senate-hearings-EATXNW5MNBATFDTUWSIDDO6RDA/ Will Republican Senator’s Concerns About Kennedy’s Vaccine Views Endanger Nomination?: https://insights.citeline.com/pink-sheet/vaccines/will-republican-senators-concerns-about-kennedys-vaccine-views-endanger-nomination-ZQMM3G6NIFAQ7NPS2WF6F22PFE/ Medicare Price Negotiation Will Continue Under Trump With Possible ‘Improvements’: https://insights.citeline.com/pink-sheet/geography/north-america/united-states/medicare-price-negotiation-will-continue-under-trump-with-possible-improvements-BD6JAB25KZDLXO7MCVDCTLEESE/ US FDA Senior Staff Return To Office In February, Next Steps for Schedule F Reclassification: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-senior-staff-return-to-office-in-february-next-steps-for-schedule-f-reclassification-ETI5TGY5XRACLA76GCYY2PEZ74/ US FDA Opioids Adcomm Postponed; Are Communications Freeze, Travel Ban To Blame?: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-opioids-adcomm-postponed-are-communications-freeze-travel-ban-to-blame-H4WQ4DLAJBD5HOZAWBCSRDBTIA/ Approvals The US FDA Is Not Talking About: A Communication Freeze Calendar: https://insights.citeline.com/pink-sheet/product-reviews/approvals-the-us-fda-is-not-talking-about-a-communication-freeze-calendar-DHS4X56LNNFELPXQ6JAZSGJMGA/
Summer Colling and Emma Wille speak with epidemiologists Ridwaan Ibrahim and Lucia Rodriguez-Garcia about the recent ISPOR conference. Ridwaan and Lucia discuss where they see new technologies like AI fitting into the epidemiology space as well as the advantages and disadvantages of using AI to analyze large volumes of real world data.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 24 January 2025. In this episode: semaglutide in 2027 Medicare price negotiations; J&J expects revenue growth despite challenges; Roche’s China Accelerator makes progress; Scrip Asks about the impact of political change; and Datroway’s US approval in breast cancer. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-3VZEWOJZWZHEPJGE6T2L4HOKPA/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet reporter and editors try to answer some emerging questions about the US Food and Drug Administration now that President Donald Trump has taken office. They discuss the FDA’s acting leadership (:43), an ongoing communications freeze (7:45), along with the hiring freeze and travel ban (20:49). They also discuss the impact of several executive orders on the US Centers for Medicare and Medicaid Services (26:23) and try to put the entire week’s events into perspective (33:40).Editor’s Note: This episode was recorded prior to Sara Brenner being officially named acting FDA commissioner, but the discussion about other aspects of the presidential transition still is relevant.More On These Topics From The Pink SheetWho’s Running The US FDA? Interim Team May Not Have Assumed Control: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/whos-running-the-us-fda-interim-team-may-not-have-assumed-control-S5HIPYKBZNFY3J2VHNJRY4JDYQ/ Deciphering Trump’s Executive Order On Medicare, Medicaid Payment Models: https://insights.citeline.com/pink-sheet/market-access/government-payers/medicare/deciphering-trumps-executive-order-on-medicare-medicaid-payment-models-MEWAWGHDNVES3IHTJJUJNAZJVI/ US FDA’s Trump Transition Relatively Smooth, Except For Diversity, Equity Work: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/us-fdas-trump-transition-relatively-smooth-except-for-diversity-equity-work-V367EFJBVRGLBIVJ7VGWIYUSJ4/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 17 January 2025. In this episode: a look at JPM; J&J’s Intra-Cellular buy; how JPM Day 1 deals fit into BD strategy; Scrip asks about the global state of biopharma; and what will fuel M&A activity in India this year. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JVFXFPYT4VFX5GEKYAVA55FOMU/Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In Vivo speaks with Ashley Zender, CEO of Fauna Bio, a company using AI to identify drug targets based on natural disease resistance in animals. The company's $494m partnership with Eli Lilly is a testament to the value of their approach.
Juho Jalkanen, CEO of Faron Pharma, discusses the importance of addressing unmet medical needs in cancer through breaking treatment resistance and developing long-term solutions. In Vivo questions the current progress of their lead asset BEXMAB and its potential moving forward.
Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms (:24), comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters (12:35), and diverging trends between CDER and CBER novel application approvals (21:53).More On These Topics From The Pink SheetTrump’s US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trumps-us-fda-reforms-need-center-director-staff-support-to-succeed-former-leaders-say-VCCGXSBJGZGXPHEYJFAHIHEI7A/ Exit Interview: US FDA’s Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible’: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/exit-interview-us-fdas-patrizia-cavazzoni-says-cder-staff-in-best-place-possible-IN6GTBFEJZDSNOI4T23CRYK7OY/ Innovation Drives Divergence: US FDA Drugs and Biologics Centers Follow Own Trajectories: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/innovation-drives-divergence-us-fda-drugs-and-biologics-centers-follow-own-trajectories-MDZ5DSCKKNEYPF6PVTXAMFHGF4/ US FDA’s Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/us-fdas-median-review-time-remains-less-than-one-year-despite-swell-of-missed-goal-dates-VIEE6AVOQRGMZNKB53B52GPQG4/ Clocking The Speed Of US FDA 2024 Novel Approvals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/clocking-the-speed-of-us-fda-2024-novel-approvals-3HT7CAIO4VBJDIJZVGBHLAUCSY/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 10 January 2025. In this episode: key themes for JPM; 2024 launches a breakout for liver disease; obesity drug readouts this year; IgA nephropathy snapshot; and only half of 2024 launches were from big pharma.https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-SV3WFD7NQJEW3FDTUDZICD2IKE/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni’s surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA’s decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48).More On These Topics From The Pink SheetDigging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/ Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/ Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway’: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/accelerated-approval-us-fda-explains-when-a-confirmatory-trial-is-underway-YP2DRCCKFBHJHOJ7K7LKH2AX4U/ Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/off-label-communications-us-fda-clarifies-safe-harbor-for-firm-generated-presentations-DEDRJWWNWBAUJPTEVI2GLHGI4M/ US FDA Still Reviewing Rare Pediatric Disease Designation Requests Despite Program Lapse: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-still-reviewing-rare-pediatric-disease-designation-requests-despite-program-lapse-EJSANI3SL5GATG66ZMVYVCME4E/
트럼프 대통령의 취임 직전 열리는 2025년 JP모건 헬스케어 컨퍼런스에서 라이센스딜 및 M&A 뿐 아니라 미국 정치와 정책도 주목 받을 것이라는 Scrip 기사의 요약입니다.https://insights.citeline.com/scrip/conferences/jp-morgan/jpm-2025-deals-politics-and-parties-to-welcome-a-new-year-for-pharma-5XBXOFPQMNB3ZBWVSWIIY5Y7IM/Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
As we enter 2025, In Vivo convened a group of biotech executives for a wide-ranging conversation about dealmaking this year and the challenges and opportunities for companies in the cardiometabolic, longevity, radiopharmaceuticals and cancer spaces. Essential listening before JPM.
In this episode of the In Vivo podcast, Harvard immunologist and co-founder of early-stage biotech Corner Therapeutics, Jonathan Kagan, talks about harnessing the power of the innate immune system by weaponizing dendritic cells and creating immunotherapies that are safer and more durable.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.Related Links:https://insights.citeline.com/medtech-insight/pickleball-smart-homes-brain-games-caregiving-agetech-take-centerstage-at-aarps-ces-2025-presence-CIGK5RS7EVG2XH3XBQSUYDQXI4/
Emma and Summer meet with Datamonitor Healthcare analyst Ken Hoang, to discuss the non-alcoholic steatohepatitis (NASH) treatment market
Scrip이 선정한 2024년의 Top 5 글로벌 제약바이오 뉴스입니다.https://insights.citeline.com/scrip/business/deals/the-top-five-pharma-stories-of-2024-GSROXP3WAZBWXGV4YP6VJML3YY/Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
Audio roundup of selected biopharma industry content from Scrip over the business week ended 20 December 2024. In this episode: Pfizer’s 2025 policy outlook; made in China blockbuster elusive; Vertex’s pain plans; Q3’s top 10 drugs; and sickle cell disease at ASH. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JGJEXCVFMVCMFKUYS6K32YZJ34/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Audio roundup of selected biopharma industry content from Scrip over the business week ended 13 December 2024. In this episode: a snapshot of the atopic dermatitis market; Bill Burns profile; GSK’s Blenrep makes a comeback; CML results at ASH; and what’s driving optimism on India. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Generics Bulletin's editorial team discusses key topics from the year, including the latest rankings of the GB Top 50, Amgen's surprise launch of a US Eylea biosimilar, the EU's Urban Waste Water Treatment Directive and supply-chain issues for the off-patent sector.
Learn how utilizing a site network can improve clinical trial efficiency and scalability, data quality, patient access and recruitment, resource optimization, and regulatory compliance. Discover more about speeding clinical trials with the use of site networks.
Summer Colling speaks with Emma Wille about the Psychedelic Symposium at the University of Wisconsin-Madison and what the future of psychedelic therapeutics could look like.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 December 2024. In this episode: Zepbound bests Wegovy; Novartis and PTC’s Huntingdon’s deal; Vabysmo hopes to ride new listing, data in Asia; Leo Pharma gains momentum; and Immunic’s hopes for MS drug. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-FU2EL35AAJBGLIK4EL7KVQRAGU/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this episode of the In Vivo podcast, Peter Flynn, CEO of Arialys Therapeutics, discusses the exciting field of autoimmune neuropsychiatry and the company’s monoclonal antibody, which it is investigating for the treatment of a rare condition called anti-NMDA receptor encephalitis and potentially other indications.
Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccine pediatric indications under the Trump Administration (:24), the DOGE commission’s search for spending cuts and its impact on the FDA (12:52), as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program’s costs (22:52).More On These Topics From The Pink SheetPediatric COVID Shots, Still Under EUA, Would Be Vulnerable In Anti-Vax HHS: https://insights.citeline.com/pink-sheet/vaccines/pediatric-covid-shots-still-under-eua-would-be-vulnerable-in-anti-vax-hhs-UWJRLYQUCJEWTLC42IFR7X2XFY/ Can US FDA Dodge DOGE? Return To Office Mandate May Be Biggest Hit: https://insights.citeline.com/pink-sheet/legislation/elections/can-us-fda-dodge-doge-return-to-office-mandate-may-be-biggest-hit-5G5SYM3ACNAKLHSSHQL32KJN5Y/ 340B Plan B: Pharma Pivots To Rebate Pricing Model After Pharmacy Restrictions Fall Short: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/340b-plan-b-pharma-pivots-to-rebate-pricing-model-after-pharmacy-restrictions-fall-short-M5DTVTFXVZA37IQ6CXMTDW4QMI/
Emma and Summer meet with oncology analysts Neha Anand and David Dahan, to discuss an emerging class of drugs: bispecific antibodies.
In this episode of the In Vivo podcast, Michelle Werner, CEO of Alltrna, discusses using tRNA as a therapeutic modality for rare diseases, including those stemming from nonsense mutations.
Biopharma is evolving through collaboration, early-phase deal-making and innovation in precision medicine and AI. At BIO-Europe, Norstella's subject matter experts explored key trends shaping the industry, from market access strategies to sustaining growth through partnerships.In this episode, Izabela Chmielewska, Kevin Grogan, and Natasha Choukkar discuss takeaways – from advancing personalized treatments to tackling the patent cliff – highlighting how Norstella empowers organizations to navigate complexity and drive innovation.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 29 November 2024. In this episode: Marks on Trump’s threat to FDA; Amgen’s Phase II MariTide data lack clarity; Roche’s Poseida buyout; Roche’s CMO on his biotech lessons; and what Trump 2.0 might mean for India. https://insights.citeline.com/scrip/podcasts/quick-listen-scrips-five-must-know-things-GIXQTTFOANHRLAWTJEMLY6Z2LI/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
A preview of the 2024 Scrip Awards and an interview with last year’s Executive of the Year, David Zaccardelli, CEO of Verona Pharma.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 22 November 2024. In this episode: Novo’s semaglutide looks good in NASH; J&J’s psoriasis drug hits multiple Phase III goals; NASH competition gets serious; China dominates APAC and increasingly global trials; and why has M&A decreased in 2024.https://insights.citeline.com/scrip/podcasts/quick-listen-scrips-five-must-know-things-YDQU2ROM3JAXDD72TMXMOYZGGE/Link to APAC Clinical Trials White Paper: https://www.citeline.com/en/resources/exploring-the-asia-pacific-clinical-trials-landscapePlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization (:30), as well as the changes Dr. Mehmet Oz, President-elect Donald Trump’s controversial selection of to run the US Centers for Medicare and Medicaid Services, could impose if confirmed (22:35).#pharma #businessMore On These Topics From The Pink SheetTrump’s US FDA User Fee Cycle: ‘An Underappreciated Threat’: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/trumps-us-fda-user-fee-cycle-an-underappreciated-threat-GVVSHUIRXBDOHDLWQXHSLC2U4A/ Medicare Price Negotiation Under CMS Chief Oz May See Early 2025 Test: https://insights.citeline.com/pink-sheet/agency-leadership/medicare-price-negotiation-under-cms-chief-oz-may-see-early-2025-test-UOROAUBSE5CWJC65XK6Q5I37SE/ CMS Administrator Nominee Oz Is ‘Communicator’ In Sync With RFK’s Healthy Living Focus: https://insights.citeline.com/pink-sheet/agency-leadership/cms-administrator-nominee-oz-is-communicator-in-sync-with-rfks-healthy-living-focus-CHOJUI4DWVCWRFQMBZXCQYAGB4/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 15 November 2024. In this episode: muscling into the obesity market; AbbVie’s schizophrenia failure; Bayer will not take risky bets; generally strong Q2 for Japanese majors; and AstraZeneca juggles China and growth questions. https://insights.citeline.com/scrip/podcasts/quick-listen-scrips-five-must-know-things-6XHHXGKMXRBV7MMKZE2NJRDG6A/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump’s potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS (:37), whether lasting changes are coming to the FDA (13:00), and Commissioner Robert Califf’s request that industry help preserve the agency status quo (18:18).More On These Topics From The Pink SheetSpeed Of Novel Approvals In Jeopardy As RFK Jr. Lands US HHS Secretary Nod: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/speed-of-novel-approvals-in-jeopardy-as-rfk-jr-lands-us-hhs-secretary-nod-PBKQI3K2XBHK5F53ZBHRD6VX2Q/ Three Ways Trump Could Disrupt The US FDA: https://insights.citeline.com/pink-sheet/legislation/elections/three-ways-trump-could-disrupt-the-us-fda-5KPABNKMKVBWNMFBQGU6H6ZWKU/ Industry Support Key To US FDA’s Prospects Under Trump, Califf Says: https://insights.citeline.com/pink-sheet/legislation/elections/industry-support-key-to-us-fdas-prospects-under-trump-califf-says-73IBZRFLQVEERACL64N74IK5GM/ Republican Sweep Creates Smoother Path For Biopharma Policy Priorities: https://insights.citeline.com/pink-sheet/legislation/elections/republican-sweep-creates-smoother-path-for-biopharma-policy-priorities-R2UH6ULEN5DKHOOV3KGYSMSETE/ Anticipation And Trepidation About Trump’s Election Rise: https://insights.citeline.com/pink-sheet/legislation/elections/anticipation-and-trepidation-about-trumps-election-rise-YTCHNKQW4VA3PPY3GBF3BQLAOQ/
Scrip senior writer Joseph Haas discusses recent merger-and-acquisition activity in the biopharma sector with Gerardo Ubaghs, CFO of Frontier Medicines, and Jason Silvers, CFO of Generate Biomedicines. The panel looks at why M&A activity metrics declined during both the second and third quarters despite a strong start to the year and apparent positive conditions for dealmaking, as well as what impact the US election results could have on M&A going forward.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 8 November 2024. In this episode: what Trump might mean for pharma; Novo’s semaglutide hits mark in NASH; AstraZeneca leads the way in clinical trials; Viking’s weight loss data excite; and how to speed up MLR reviews. https://insights.citeline.com/scrip/quick-listen-scrips-five-must-know-things-D4FI3E5BCNF2HNIP6TPK5KQ2A4/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In the latest episode of the In Vivo podcast, Noam Solomon, co-founder and CEO of Israeli-American biotech Immunai explains how his company is mapping the immune system and using AI to predict individual immune responses to drugs. Noam also discusses the company's own acquisitions, partnerships, the differences between innovation and invention, artificial biomedical intelligence (ABI) and barriers to personalized medicine.
Contract development and manufacturing organizations (CDMOs) are reshaping pharmaceutical production, playing a pivotal role in supply chain stability and driving innovation. In today’s fast-evolving environment, CDMOs help life sciences companies enhance speed, flexibility, and efficiency, which ultimately advances access to life-saving therapies. Norstella provides tailored insights, tools, and intelligence solutions to support this progress, empowering companies to make informed decisions and optimize their manufacturing partnerships.This year at CPHI Milan, our team observed key industry trends, including innovations to strengthen supply chains and enhance sustainable practices. At Citeline’s (a Norstella company) 11th Annual Global Generics & Biosimilars Awards, we also celebrated excellence in the generics sector. Following the conference, Andrea Charles, VP of custom content at Norstella, and Andrew Warmington, Citeline’s manufacturing editor, joined Izabela Chmielewska, managing editor of custom content, to discuss major takeaways – from the BIOSECURE Act’s influence on global operations to advancements in biomanufacturing. Together, they explored how Norstella and Citeline drive solutions to streamline the journey from pipeline to patient.
Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make on the FDA, as well as worries about political interference in decision-making, and policy and staffing changes.More On These Topics From The Pink SheetUS FDA’s Drug Approval Norms Could Be Upended In Second Trump Term: https://insights.citeline.com/pink-sheet/legislation/elections/us-fdas-drug-approval-norms-could-be-upended-in-second-trump-term-ICH6FUN4OBHRJPN4QFJ4OPLHNU/Warp Speed For All And A Boost For Small Biotechs In Trump’s Second Term, Ex-Official Says: https://insights.citeline.com/pink-sheet/legislation/elections/warp-speed-for-all-and-a-boost-for-small-biotechs-in-trumps-second-term-ex-official-says-DA3BUPKEWVGVNDEPG6JMVLV7UI/With Trump’s Return, Pharma Trades Disagreeable Knowns For Uncertainty: https://insights.citeline.com/pink-sheet/legislation/elections/with-trumps-return-pharma-trades-disagreeable-knowns-for-uncertainty-N7ZMT6QOEZEUDEXOROKXAZBP6E/FTC Under Trump Likely to Maintain PBM Focus But M&A Oversight May Moderate: https://insights.citeline.com/pink-sheet/legislation/elections/ftc-under-trump-likely-to-maintain-pbm-focus-but-ma-oversight-may-moderate-H3XQ4S3YJBDSBK2NIDZFM4ZQ34/
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia at HTLH on his vision for AI in health care. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 1 November 2024. In this episode: Lilly plans DTC tirzepatide ads; Pfizer’s Bourla defends strategy; expert views from BioFuture; China retains attractions for some; and AbbVie’s Aliada acquisition.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「Déjà Vu In England: Lilly’s Alzheimer’s Drug Kisunla Gets MHRA Yes, But NICE Says No（邦訳：アルツハイマー治療薬ケサンラ承認で議論再び、薬価負担に悩む英国）」URL: https://insights.citeline.com/pink-sheet/geography/europe/united-kingdom/deja-vu-in-england-lillys-alzheimers-drug-kisunla-gets-mhra-yes-but-nice-says-no-OX4YRPW4AFAYXAQVANZSSHURP4/※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip
Audio roundup of selected biopharma industry content from Scrip over the business week ended 25 October 2024. In this episode: Merck & Co’s Modifi acquisition; scenarios for new obesity drugs; Astellas gets US approval for claudin drug Vyloy; iTeos builds TIGIT lead; and execs discuss AI in clinical trials.https://insights.citeline.com/scrip/quick-listen-scrips-five-must-know-things-YMAHSAK2FBBKPIPNLZGPGHWPSQ/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Health technologies are revolutionizing the ways in which life sciences organizations develop and deliver life-saving treatments to patients. In particular, digital therapeutics have become a prominent area of focus due to their potential to improve outcomes while reducing patient burden. Norstella continues to be proponent for these innovative technologies, partnering with organizations to launch their digital therapeutics products to market both seamlessly and with the patient in mind. That being said, we always stay up to date with the evolving landscape by attending meetings that bring together decision-makers with diverse expertise and fresh perspectives.LSX World Congress USA, which took place between September 11-12, 2024 in Boston, MA, addressed the complex investment, partnership, and innovation aspects of digital therapeutics. After attending the conference, Janelle Hart, managing editor, custom content at Citeline, sat down with principal and head of Digital Health & Access Innovation Strategy Tony Shi and consultant Eric Boyda from The Dedham Group, a Norstella company, to explore key takeaways from the meeting, what the future holds for digital therapeutics, and how Norstella and the Dedham Group are making strides in this sector to smooth the path from pipeline to patient.To listen to part 1 of this podcast, go to this link: https://soundcloud.com/citelinesounds/lsx-world-congress-usa-key-takeaways?si=6fa75aae9d7f45febcfe0bb6762a62aa&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharingFor more information on Norstella’s capabilities as a healthcare technology partner, visit: https://www.norstella.com/To learn more about the Dedham Group, contact Tony or Eric at: tony.shi@norstella.com or eric.boyda@norstella.com
Emma and Summer meet with oncology analysts Neha Anand, Anna Simmons, and Nkiru Ibeanu, to share insights from the European Society of Medical Oncology (ESMO) conference.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 18 October 2024. In this episode: J&J looks to Tremfya as Stelara declines; Pfizer’s Hympavzi may find hemophilia B niche; big pharma’s cell and gene therapy realities; M&A took a holiday in Q3; and last rites for Sanofi’s RIPK1 drug.https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-CMKHTUFVBBDQ3DSTX3KJALGCQI/Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations (:25), legal wrangling related to compounding GLP-1 drugs for obesity and diabetes (14:20), and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable (29:08)#pharma #businessMore On These Topics From The Pink SheetKeytruda, Opdivo SubQ Conversions Cloud Near-Term Medicare Negotiation Savings Forecasts: https://insights.citeline.com/pink-sheet/keytruda-opdivo-subq-conversions-cloud-near-term-medicare-negotiation-savings-forecasts-BJNQCECWVNESHGCKNPJSKVIH4I/ GLP-1s: Compounders Get Temporary Reprieve But US FDA May Be Building Stronger Case: https://insights.citeline.com/pink-sheet/legalandip/litigation/glp-1s-compounders-get-temporary-reprieve-but-us-fda-may-be-building-stronger-case-2SJVLIMS5FDERNWA7UQV3IM7JM/ US FDA Opinions Vary On AI’s Black Box Issues. Will Uncertainty Follow?: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/us-fda-opinions-vary-on-ais-black-box-issues-will-uncertainty-follow-PPMN3R3FJ5BTZOXWDFHPHZVLNQ/
빅파마들은 세포유전자 치료제를 출시하면서 이러한 치료의 비용과 복잡성이라는 현실적인 문제에 직면해 있습니다. 최근 개최된 메사 세포유전자 회의를 취재한 Scrip 기사를 요약한 내용입니다. https://scrip.citeline.com/SC151041/Big-Pharma-Faces-Cell-And-Gene-Therapy-Market-RealitiesPlaylist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
Dexter Yan回顾了他在国庆长假前和阿斯利康全球执行副总裁-生物制药研发负责人Sharon Barr的采访。此外，本期播客迎来了Citeline Insights团队在上海的新成员、资深记者Xu Hu。她分享了先为达生物伊诺格鲁肽的最新III期临床数据，以及中国律师对美国生物安全法案影响的分析。
Audio roundup of selected biopharma industry content from Scrip over the business week ended 11 October 2024. In this episode: making cell and gene therapies more accessible; Roche’s obesity plans; Biosecure and Indian firms; IPOs begin to recover; and Nxera looks to the future.https://scrip.citeline.com/SC151048/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Introduction: Pink Sheet reporter and editors discuss experts’ experience helping drug sponsors negotiate prices with CMS (:33) and the FDA’s proposal for a new pathway to update vaccines before a pandemic is declared (12:02).More On These Topics From The Pink Sheet:Perspectives From The Front Lines: Navigating The First Round Of Medicare Price Negotiation: https://pink.citeline.com/PS155353/Perspectives-From-The-Front-Lines-Navigating-The-First-Round-Of-Medicare-Price-Negotiation US FDA Proposes New ‘Inter-Pandemic’ Pathway For Updating Flu Vaccines: https://pink.citeline.com/PS155345/US-FDA-Proposes-New-Inter-Pandemic-Pathway-For-Updating-Flu-Vaccines US FDA Advisors Urge Faster Movement, mRNA Consideration, In Updating Pandemic Flu Vaccines: https://pink.citeline.com/PS155358/US-FDA-Advisors-Urge-Faster-Movement-mRNA-Consideration-In-Updating-Pandemic-Flu-Vaccines
Join us for a discussion on pediatric psoriasis and the importance of collaboration across specialties to improve treatment outcomes.
Richard Lowenthal, co-founder, and CEO of ARS Pharma, highlights the crucial unmet need for needle-free injections. Challenging issues posed by current epinephrine injectors, In Vivo questions the current and future progression of Neffy.
In the latest episode of the In Vivo podcast, Russ Lebovitz, the co-founder and scientist behind Amprion, a diagnostics company, discusses the role of alpha-synuclein misfolding in neurodegenerative diseases and how early alpha-synuclein detection has the potential to mitigate the impacts of diseases ranging from Parkinson's disease to Lewy body dementia.
Join us for an informative discussion about PIK3CA testing and treatment with Dr. Neil Iyengar
Discover the game-changing insights from the LSX World Congress USA!Join Janelle Hart, Managing Editor at Citeline, a Norstella Company, as she explores the key takeaways from the LSX World Congress USA meeting. In this episode, Janelle sits down with Tony Shi, Principal and Head of Digital Health and Access Innovation Strategy, and Eric Boyda, Consultant at The Dedham Group, to unpack the insights from this two-day event that brought together the brightest minds in biotech, medtech, and healthtech in Boston.Discover the challenges and opportunities shaping the future of healthcare technology, from groundbreaking innovations to strategic investments and transformative partnerships.Tune in now for exclusive insights and expert analysis that you won’t want to miss!
In the latest episode of the In Vivo podcast, Alan Aspuru-Guzik, a pioneer in chemical engineering who holds many positions, talks about how he is folding in robotic automation, generative AI and quantum computing in his self-driving lab.
More On These Topics From The Pink SheetPfizer Withdraws Oxbryta, But Overall Market Impact May Be Limited: https://pink.citeline.com/PS155302/Pfizer-Withdraws-Oxbryta-But-Overall-Market-Impact-May-Be-LimitedEMA Discusses Fatal Events That Prompted Pfizer To Pull Oxbryta From Global Markets: https://pink.citeline.com/PS155296/EMA-Discusses-Fatal-Events-That-Prompted-Pfizer-To-Pull-Oxbryta-From-Global-Markets New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming: https://pink.citeline.com/PS155285/New-US-FDA-Adcomm-Trend--Approved-Cancer-Meds-Get-Another-Look-When-Competitors-Coming All Comers No More? US FDA AdComm Supports PD-L1 Threshold In Esophageal, Gastric Cancer: https://pink.citeline.com/PS155300/All-Comers-No-More-US-FDA-AdComm-Supports-PDL1-Threshold-In-Esophageal-Gastric-Cancer Pazdur Calls For 'Kumbaya’ To Standardize ImmunoOncology Biomarkers: https://pink.citeline.com/PS155298/Pazdur-Calls-For-Kumbaya-To-Standardize-ImmunoOncology-Biomarkers New AAM CEO Looking To ‘Force Multiply’ For US Generics Industry: https://pink.citeline.com/PS155294/New-AAM-CEO-Looking-To-Force-Multiply-For-US-Generics-Industry
Executive Summary: In this podcast, Andrew Warmington, Manufacturing Editor, Citeline, joins together with industry experts, Simone Secchi, R&D Process Chemist, Olon Group, and Matthieu CULIE, Head of MAB, Pierre Fabre, to discuss the challenges in the development and manufacturing of ADCs.
Emma Wille chats with oncology team director Dana Gheorghe, PhD, about the resurgence of radiopharmaceutical therapies in oncology.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/
In this podcast, Janelle Hart, Managing Editor at Citeline, teams up with industry experts Mai Yee Mishir, Senior Director of Global Regulatory Affairs, and Sally-Ann McDowell, Senior Director of Clinical Development Strategy at Advanced Clinical, to discuss the vital role of HRQoL in clinical trials. Listen now.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 30 August 2024. In this episode: summer ADC dealmaking continues apace; a look at cell therapies in Japan; Pfizer’s new US digital consumer platform; Galapagos’s US point of care CAR-T study; and Novartis partners with Lindy on biologics delivery.https://scrip.citeline.com/SC150827/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet reporter and editors discuss new developments in the FDA’s plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development.More On These Topics From The Pink Sheet Artificial Intelligence: CDER’s New Council Takes Charge Of Oversight, Coordination: https://pink.citeline.com/PS155173/Artificial-Intelligence-CDERs-New-Council-Takes-Charge-Of-Oversight-Coordination AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role: https://pink.citeline.com/PS155156/AI-In-Drug-Development-Regulatory-Clarity-Needed-On-Inspections-Human-Role
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app. Stories discussed in this episode:MindMaze, ‘A Ratio Of Luke Skywalker And R2-D2’, Navigates The DTx GalaxyClick Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical StageSinaptica On Precision Neuromodulation To Combat Alzheimer’s: ‘No Drug Dares Go After Moderate Patients’DHCoE-AI-Lifecycle-Management-Plan-To-Serve-As-Playbook-For-StandardsHello Heart Says Update To Cardiovascular Health Tracker Could Benefit Women Especially
Interest in the human gut microbiome and the influence it exerts on a person’s wellbeing, from cognitive health to immunity, has been rapidly increasing in recent years. In this episode of HBW Insight's Over the Counter podcast we speak to Dublin-based food company Kerry Group about a particularly exciting, emerging area of microbiome-based wellness, postbiotics, which are defined by the International Scientific Association of Probiotics and Prebiotics (ISAPP) as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.” Given that postbiotics rely on inanimate ingredients, rather than live cultures as in yoghurts, they, may provide more suitable vehicles for consumer health innovation, suggests Kerry Group’s RDA senior manager of immune and joint health, Sonja Nodland. Nodland also explains what kinds of postbiotics are currently on the European market, for example for digestive and skin health and immunity, and the regulatory challenges that postbiotics share with other microbiome products in the region, such as pre- and pro-biotics.Timestamps:2:20 Introductions4:00 What are postbiotics?8:30 Advantages of postbiotics for consumer health innovation10:20 Health benefits of postbiotics12:00 Types of postbiotics15:20 Kerry’s postbiotic portfolio19:00 Postbiotic regulation in the European Union28:00 Where to start with postbiotic innovation
Audio roundup of selected biopharma industry content from Scrip over the business week ended 23 August 2024. In this episode: CMS’s price reveal better than expected?; new diabetes risk data for Zepbound; can J&J’s lung cancer combo stand up to Tagrisso?; new recruits for BioMarin leadership; and Glenmark’s shifting revenues.https://scrip.citeline.com/SC150795/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Following the recent FDA rejection of MDMA therapy for PTSD, Emma and Flora discuss the future role of psychedelics in the treatment of mental health disorders. Content warning: This episode does contain mentions of sexual assault and abuse.Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Keith Murphy, co-founder of Organovo, discusses the growing potential of bioprinting and how the company is using its technologies to study and develop treatments for inflammatory bowel disease (IBD).
Audio roundup of selected biopharma industry content from Scrip over the business week ended 16 August 2024. In this episode: Merck & Co. steps into CD19 bispecific space; gene therapy patients rise, but slowly; Madrigal’s Rezzdifra plans; Korean biopharma financing recovering?; and approvals to watch out for in Q3.https://scrip.citeline.com/SC150765/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding.More On These Topics From The Pink SheetMedicare Negotiation Announcement: Discounts From List Price Up To 79%, But Net Savings Unclear: https://pink.citeline.com/PS155128/Medicare-Negotiation-Announcement-Discounts-From-List-Price-Up-To-79-But-Net-Savings-Unclear Medicare Unveils Negotiated Prices, But Near-Term Opportunity To Learn From Process Is Limited: https://pink.citeline.com/PS155129/Medicare-Unveils-Negotiated-Prices-But-NearTerm-Opportunity-To-Learn-From-Process-Is-Limited Round 1 Of US Drug Price Negotiations Suggests Medicare Can Beat Original Part D System: https://pink.citeline.com/PS155130/Round-1-Of-US-Drug-Price-Negotiations-Suggests-Medicare-Can-Beat-Original-Part-D-System The Next 340B Battle: Discount Duplication With Medicare Negotiated Prices: https://pink.citeline.com/PS155043/The-Next-340B-Battle-Discount-Duplication-With-Medicare-Negotiated-Prices
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちらWhat To Look Out For At ESC 2024https://scrip.citeline.com/SC150740/What-To-Look-Out-For-At-ESC-2024
Compliance with environmental sustainability goals is no longer optional for medtech companies serving global healthcare markets. Thermo Fisher has made it a mission to be a leader in thought and actions in meeting Scope 1, 2 and 3 needs. Corporate VP and head of sustainability Meron Mathias explains the company's sustainability aims and methods, for itself and its customers, and stresses the importance of continuing to enhance patient care with innovative products at the same time.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 August 2024. In this episode: Amgen positions for obesity and diabetes; BMS returns TIGIT asset in pipeline reshuffle; is Kerendia the next jewel in Bayer’s crown?; Japan pharma firms cut jobs; and Sun Pharma seeks GLP-1 partner.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Since becoming a standalone consumer health company, Haleon has been driving awareness of public health issues such as chronic pain and children’s oral health. In this episode of Over the Counter, HBW Insight catches up with Haleon vice president and general manager Great Britain and Ireland Bas Vorsteveld, to find out more about why having a purpose is so important to establishing and growing a consumer health brand, looking in particular at the firm’s recent Aquafresh campaign, which saw it team up with British photographer, Rankin, to capture powerful portraits of children’s growing teeth to encourage them to be more confident. We also talk about Haleon’s ambitious climate commitments, and why ambition is important, alongside transparency about the challenges that such ambition brings.2:00 – Introductions2:50 – Aquafresh x Rankin8:00 – The Importance of Having a Purpose12:15 – Advantages of Being a Standalone15:30 – Sustainability as Purpose19:20 – Leading by Example23:20 – Aiming High25:20 – Being Transparent’26:50 – Haleon’s Two-Year Anniversary30:00 – VMS Growth and Preventative Health32:20 – Pain Against the Grain37:00 – The Year Ahead
In this audio, Dr. Anthony Fritz discusses Type 2 diabetes and the benefits of SGLT2 inhibitors. Learn how this treatment option can improve diabetes care.
올해 상반기 일라이 릴리와 노보 노디스크의 주가가 가장 높은 상승세를 보인 반면, BMS와 길리어드의 주가는 가장 큰 폭으로 하락했습니다. Scrip의 글로벌 제약주 동향 기사를 요약한 내용입니다.https://scrip.citeline.com/SC150593/Obesity-Rules-Large-Cap-Stocks-In-First-Half-Of-2024
Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 August 2024. In this episode: Pfizer bullish on its oral GLP-1; BMS’s rising confidence about Medicare pricing of Eliquis; more long term data for Leqembi; NewAmsterdam’s CETP inhibitor shows promise; and a look at Mankind’s Bharat Serums buy.https://scrip.citeline.com/SC150698/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14).More On These Topics From The Pink SheetDozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-ApprovalBMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-PushEU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation: https://pink.citeline.com/PS155059/EU-Pilot-On-Raw-Data-Analysis-Shows-Benefits-For-Streamlining-Medicines-Evaluation
RNK Pharma founder and CEO Yaning Wang joins Brian Yang to discuss Shanghai's latest biopharma stimulus policies and the globalization of China biotech. Dexter Yan also discusses China biotech initial public offerings in the first half of this year.
COPD expert Wen-Yu discusses what the entrance of biologics might mean for the COPD treatment landscape and shares a sneak peek from her upcoming patient-based forecast.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 July 2024. In this episode: Narasimhan plays the long game; Merck & Co’s RSV contender; Mounjaro’s China approval; the mid-cap rising stars; and AI could add billions in drug revenues.https://scrip.citeline.com/SC150656/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Join Victoria Bradley and Dr. Andrew Freeman as they discuss the latest advancements in heart failure treatment, from innovative therapies to the role of AI and personalized medicine. Discover how technology is revolutionizing patient care, ensuring patient safety, and improving outcomes.
This Q&A session emphasizes early diagnosis of COPD for better lung function preservation and disease control. It explores COPD symptoms, diagnosis tools, treatment options, and the importance of lifestyle changes, especially smoking cessation.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room.Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in this episode: Zeto Wins FDA Clearance For Novel Seizure Detection DeviceOutdated Technology Keeping Surgeons From Operating At Their Best: Medtronic Report :: Medtech InsightDeepWell DTx Brings Mental Health To Meta StoreHealthtech Leaders Discuss Impact (And Risks) Of Generative AI And AI In Health Care Is This Doomsday Concern, Or Is It Reality? Verily CMO On AI’s Future, Lightpath Metabolic, More News We’re Watching: UK Plans Digital Health Guidance, FDA Warns Against Getinge/Marquet Cardiac Devices
Audio roundup of selected biopharma industry content from Scrip over the business week ended 19 July 2024. In this episode: J&J’s Spravato on track for blockbuster status; US uptake of Rezzdifra held up by payers; CNS drugs are surprisingly valuable; obesity rules large cap stocks; and Legend buyout rumors validate China biotech.https://scrip.citeline.com/SC150621/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.
Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.More On This Topics From The Pink SheetPharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals: https://pink.citeline.com/PS154948/Pharma-Looks-To-America-First-US-FDA-Holds-Overwhelming-Lead-Over-EMA-In-Novel-Approvals Getting To Global Is A Hurdle For Cell And Gene Therapies: https://pink.citeline.com/PS154953/Getting-To-Global-Is-A-Hurdle-For-Cell-And-Gene-Therapies New Oncologics Overwhelmingly Approved In US Before EU: https://pink.citeline.com/PS154952/New-Oncologics-Overwhelmingly-Approved-In-US-Before-EU Approval Geography: Novel Agent Landscape Across US And EU: https://pink.citeline.com/PS154950/Approval-Geography-Novel-Agent-Landscape-Across-US-And-EU US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals: https://pink.citeline.com/PS154951/US-FDA-Offers-Faster-Route-To-Market-Than-EMA-Details-On-All-108-Approvals
신테카바이오 조해경 사장은 Scrip과의 인터뷰에서 국내 AI 신약 개발 현황을 글로벌 흐름와 비교하고, 국내외 경쟁에서 살아남기 위해 국내업계가 해야 할 일에 대해 이야기했습니다.https://scrip.citeline.com/SC150336/Korea-Looks-To-Close-Gap-In-AI-Drug-Development-Capabilities
Discover the key considerations critical to the genetic analysis for advanced therapies, including qPCR and dPCR. Don’t miss expert insights from Chandler Walker, Product Manager of Digital PCR Instruments at Thermo Fisher Scientific and Janelle Hart, managing editor at Citeline.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 12 July 2024. In this episode: Q1’s top 10 drugs; Pfizer’s R&D leadership succession; Lilly bolsters IBD pipeline; first half deal volume up but value down; and EU firms’ China sentiment plummets.https://scrip.citeline.com/SC150587/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials.
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「US FDA’s Cell-Gene Therapy Office Head Wants Sponsors To Seek Out Meetings（ 邦題意訳：米国FDAの細胞遺伝子治療室長「もっと面談を」企業に求める理由は）」 （日本語版）[Japanese version’s URL to be published]※全文の閲覧には情報の登録（無料）が必要です。（英語版）https://pink.citeline.com/PS154749/US-FDAs-Cell-Gene-Therapy-Office-Head-Wants-Sponsors-To-Seek-Out-Meetings※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip
Audio roundup of selected biopharma industry content from Scrip over the business week ended 5 July 2024. In this episode: US approval for Lilly’s Alzheimer's contender; the challenges and rewards of late-stage ADCs; Eisai regains control of ADC from BMS; RSV vaccine developers hit by declining expectations; and an interview with Amgen’s Ian Thompson.https://scrip.citeline.com/SC150550/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this episode of the In Vivo podcast, Billy Boyle, CEO of Owlstone Medical, discusses how his company is developing several breath biopsy products for use by clinicians, biopharma companies and researchers.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 June 2024. In this episode: global CEO remuneration; another late-stage loss for Merck KgaA; deals shift to smaller M&A, partnering; Bayer’s Parkinson’s bets bear fruit; and India looks to innovate CAR-T models.Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials.
Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out (:35), as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making (27:30).More On These Topics From The Pink SheetDiversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says: https://pink.citeline.com/PS154894/Diversity-Action-Plans-Should-Be-Brief-And-Waiver-Requests-Filed-Early-US-FDA-Says Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups: https://pink.citeline.com/PS154895/Diversity-Enrichment-US-FDA-Guidance-Suggests-Sponsors-May-Need-To-Overenroll-Key-Groups US FDA Guidance On Artificial Intelligence For Regulatory Decision-Making Expected This Year: https://pink.citeline.com/PS154868/US-FDA-Guidance-On-Artificial-Intelligence-For-Regulatory-Decision-Making-Expected-This-Year
Guest speaker “Angus” Shipo Xie of Hankun Law joins Brian Yang to discuss new overseas data transfer rules, while Dexter Yan explains China biotechs' Hutchmed, Jiangsu Hengrui and Innovbent Bio’s clinical data readouts at the recent EHA and ADA annual meetings.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 June 2024. In this episode: the outlook for 2025 launches; Merck confident in new pneumococcal vaccine; multiple US setbacks for Japanese firms; Stock Watch on Moderna missteps; and Sun’s North America head talks plans and strategy.https://scrip.citeline.com/SC150476/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI’s journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement and compliance with the US FDA Lab Developed Test ruling.
In this episode, HBW Insight chats with women’s health start-up The SABI about the power of herbal medicine for hormonal wellness. “Inspired by a series of painfully honest conversations they had about their hormonal and emotional challenges,” The SABI markets a range of herbal infusions aimed at alleviating some of the impacts of painful periods and hormonal imbalances, such as digestive discomfort, sleep disruption and anxiety. The SABI founders Hilary Metcalfe and Anna Cave-Bigley also reveal the difficulties of being a woman-led, women’s health startup in a male dominated world, especially when it comes to funding and research. We also discuss the importance of getting the message right, both in terms of connecting women to their hormonal health but also distinguishing The SABI from less credible women’s wellness brands.Timestamps:2:00 Introductions5:00 The power of herbs11:45 The challenges of being a women’s health startup17:30 The demand for natural women’s health products24:50 Controversies surrounding natural women’s health alternatives32:45 What’s next for The SABIBiographiesAnna Cave-Bigley is CEO at The SABI, leading sales and strategy “with her signature drive and keen insight on everything from motherhood, hormone balance and mental health to strategy, sales and global operations.” From being a founding member of the international practice for a leading London communication consultancy to spearheading international investment initiatives for the British Government, Anna has honed her operational business expertise over 13 years. She is mother to Lorenzo and Alfie, who “inspired her to co-found The SABI after her devastating experience with clinical postpartum depression.”Co-founder Hilary Metcalfe is a Harvard graduate and accomplished business strategist, who dedicated 12 years to impact investment, sustainability, and management consulting before her health intervened. “Conventional medicine offered only a lifetime of medication for chronic migraines and my then-undiagnosed endometriosis. Determined to find a more natural approach, I became a certified holistic nutritionist, product developer and chef, building and selling a successful plant-based food startup in Amsterdam.” During this time Hilary began formulating the remedies and products that would become The SABI’s core collection.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 June 2024. In this episode: Boehringer best in MASH?; biopharma funding on an upswing?; Moderna’s combo jab; clinical trial recover from pandemic; and Astellas’s US commercial head speaks. https://scrip.citeline.com/SC150442/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this podcast, Janelle Hart, Managing Editor, Citeline, joins industry experts Jessica Wall, Director of Talent Acquisition, and Morgan Seaman, Associate Director of FSS Operations, both from Advanced Clinical, to discuss the latest trends and challenges in building, scaling and differentiating workforces in the life sciences sector.Talent acquisition is central to fostering creativity and innovation within any organization. In today’s highly competitive and fast-moving life sciences sector, it’s more important than ever. Tune into this free podcast to gain valuable insights on maintaining a competitive edge through innovative recruitment and retention strategies. Listen now to explore more!
The oncology team from Datamonitor Healthcare and healthcare journalist, Alaric, provide broad analytical coverage of key highlights from the ASCO 2024 conference.Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Guest speaker, US-based Pink Sheet senior writer Sarah Karlin-Smith, joins Brian Yang and Dexter Yan in China to discuss the recent BIO Conference, updates to the planned US BIOSECURE Act and industry preparations for its impact. Dexter also discusses China biotech's data highlights from ASCO 2024.https://scrip.citeline.com/SC150438/China-Biotech-Podcast-BIOSECURE-Act-Updates--ASCO-HighlightsPlaylist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma
글로벌 제약업계는 암 연구의 미래를 어떻게 보고 있을까? Scrip의 ASCO 현장 취재 기사를 요약한 내용입니다.https://scrip.citeline.com/SC150378/ASCO-Roundup-Looking-For-The-Future-Of-Cancer-ResearchPlaylist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
Audio roundup of selected biopharma industry content from Scrip over the business week ended 7 June 2024. In this episode: BIO Notebook; ASCO roundup; data on Carvykti in community at ASCO; strong new results for tirzepatide in MASH; and orphan slowdown signals new path ahead.https://scrip.citeline.com/SC150401/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Generics Bulletin's editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA's Orange Book.
Guest speaker Guangzuo Luo, chief scientific officer of Bioncetech, joins China-based editors Brian Yang and Dexter Yan in this episode, which looks at Chinese biotechs going global, and the opportunities and challenges in the latest industry latest trends.https://scrip.citeline.com/SC150370/China-Biotech-Podcast-Going-Global-Trends-Rare-Disease-Drug-DevelopmentPlaylist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma?si=80b1209c44874afa9c44bf7d30538320&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing
In an interview with Scrip, JB CEO Nikhil Chopra addresses rumours of a sale of a stake in the Indian pharma/CDMO company by private equity fund KKR, recent acquisitions, including from Novartis, as well as JB's ambitions to ramp up the cardiology segment and its CDMO business, which already has major clients including J&J and P&G.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 31 May 2024. In this episode: ASCO preview; Asahi’s US acquisition; Novartis aims for renal disease dominance; paying for gene therapies; and US BIOSECURE Act diluted.https://scrip.citeline.com/SC150361/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Advancing Investigational New Drugs (INDs) can be a complex process, especially for smaller companies. Listen to your free podcast now as Marcus Delatte, PhD, Vice President at Allucent and Harshini Neelakantan, Executive Director at Ridgeline Therapeutics discuss best practices and considerations for leveraging your pre-IND meeting and submitting a successful IND application.Listen now for insights into:• Current trends and challenges related to IND submissions• The purpose and benefits of pre-IND meetings with regulatory bodies• Indicators that should prompt companies to request a pre-IND meeting• The role of consultants in supporting sponsors in pre-IND meetings• Getting the most from your pre-IND meeting and tips for IND application success• How IND submissions will evolve in the future
Astellas Pharma’s chief commercial officer discusses the biopharma industry’s responsibility to drive change in health care.
NeuShen CEO Joan Shen discusses with Brian Yang about developing CNS drugs in China, the venture's business rationale, challenges and fundraising. She also discusses two leading assets for schizophrenia and epilepsy in first-in-human studies, as well as a gene therapy collaboration for ALS with UMass's Gao Lab.https://scrip.citeline.com/SC150328/China-Biotech-CEO-Interview-Starting-A-CNS-Venture-In-An-Economic-DownturnPlaylist: https://on.soundcloud.com/AaFyPUxfD2RiDEis5
As the 15 July entry deadline for the 3rd edition of the annual Citeline Japan Awards approaches, join us in this bilingual English/Japanese podcast to learn more about the categories and event itself. (Japanese starts at 2' 25".)English event site: https://www.citeline.com/en/awards/citelinejapanawardsJapanese event site: https://www.citeline.com/ja-jp/awards/citelinejapanawards
Audio roundup of selected biopharma industry content from Scrip over the business week ended 24 May 2024. In this episode: Biogen’s immunology acquisition; AstraZeneca looks to cement respiratory lead; why US FTC is tough on pharma; the US election’s impact on pharma; and how new AI tools are impacting medical affairs.https://scrip.citeline.com/SC150324/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet editors discuss the US FDA’s consideration of regulatory changes to promote innovative clinical trial designs (:32), an NIH proposal to require patent licensees create plans to ensure access to the commercialized product (7:29), and lawmakers longing for the days when Janet Woodcock ran the FDA’s Center for Drug Evaluation and Research (15:35).More On These Topics From The Pink Sheet‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research: https://pink.citeline.com/PS154721/US-FDA-Looking-To-Modernize-Clinical-Trial-Regulations-To-Spur-Evolution-In-Research NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional: https://pink.citeline.com/PS154744/NIH-Drug-Patent-Licensees-Would-Develop-Access-Plan-Under-Proposal-Pricing-Commitments-Optional Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach: https://pink.citeline.com/PS154745/Woodcock-Nostalgia-GOP-Rep-Bilirakis-Wants-CDER-To-Recapture-Her-Flexible-Approach
In this episode of the In Vivo podcast, Hakim Yadi, CEO and co-founder of UK techbio company Closed Loop Medicine, discusses how his company is pairing software and predictive analytics with medications old and new to tailor drug dosing to each patient.
빅파마 기업들의 블록버스터 신약 확보 전략에 대한 Scrip 기사를 요약한 내용입니다.https://scrip.citeline.com/SC150256/Development-Versus-Dealmaking-How-To-Obtain-A-BlockbusterPlaylist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
Audio roundup of selected biopharma industry content from Scrip over the business week ended 17 May 2024. In this episode: the life of a blockbuster; blockbusters by indication; gene therapy struggles; sun shines on AstraZeneca and GSK; and Korean ventures look to Japan.https://scrip.citeline.com/SC150281/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee (:30), whether industry would improve clinical trial diversity with tougher enforcement of the regulation (22:26), as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program (33:07).More On These Topics From The Pink SheetAs Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs: https://pink.citeline.com/PS154707/As-Biosecure-Bill-Mores-Forward-Clock-Ticking-For-Industry-To-Move-Away-From-Chinese-CDMOsBIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern’: https://pink.citeline.com/PS154692/BIOSECURE-Act-Update-Offers-Biotech-Companies-Eight-Years-to-Divest-Contracts-With-Firms-Of-ConcernSenate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity: https://pink.citeline.com/PS154688/Senate-Work-On-Biosecurity-Issues-Continues-Even-As-House-Is-Current-Focus-Of-Legislative-ActivityUS FDA Asked To Tighten China Risk Control By Legislators As Markup Looms: https://pink.citeline.com/PS154675/US-FDA-Asked-To-Tighten-China-Risk-Control-By-Legislators-As-Markup-Looms‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks: https://pink.citeline.com/PS154696/Do-It-Or-Were-Not-Going-To-Approve-Your-Drug-Industry-Reps-Ask-FDA-For-Trial-Diversity-SticksUS FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals: https://pink.citeline.com/PS154702/US-FDA-Using-Platform-Ideas-Outside-Of-Formal-Designations-To-Speed-Cell-and-Gene-Approvals
Flora gives an overview of the budding landscape of neoadjuvant therapy in melanoma and provides insight on the nuances of this market.Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
In this bilingual Chinese- and English-language edition, China-based editors Brian Yang and Dexter Yan, along with guest speaker Derrick Gingery from the Pink Sheet in the US, discuss the planned US BIOSECURE Act and markup vote. Brian and Dexter also look at recent R&D updates from Chinese biopharma firms on their antibody-drug conjugate pipelines.https://scrip.citeline.com/SC150255/China-Biotech-Podcast-BIOSECURE-Markup-Biotech-Pipeline-UpdatesOther podcasts in the series: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma
Audio roundup of selected biopharma industry content from Scrip over the business week ended 10 May 2024. In this episode: AstraZeneca’s Vaxzevria farewell; the next wave of cardiometabolics; Pfizer recruits prominent analyst: foundation pleas for China rare disease therapies; and Gossamer partners up for respiratory therapy.https://scrip.citeline.com/SC150240/Quick-Listen-Scrips-Five-MustKnow-ThingsPlaylist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.
In this episode, HBW Insight chats with sustainable packaging expert Tony Perrotta about why it’s so difficult to replace plastic pill packs in medicines packaging. Perrotta works for PA Consulting, which set up the Blister Pack Collective alongside consumer healthcare partners Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the collective hopes will be ready to commercialize in the next 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which also hopes to use the same dry molded fiber technology to replace plastic bottles in food, personal care and consumer health industries, will soon be launching its first market trial.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 3 May 2024. In this episode: Japan’s Ono buys US oncology firm; strong growth but supply issues for Lilly; Novo and Lilly make their money work; BMS cuts jobs, costs; and Big Pharma’s support for bioventures.https://scrip.citeline.com/SC150211/Quick-Listen-Scrips-Five-MustKnow-ThingsMore podcasts in this series: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things?si=17107bcf40ad4c54b5148e7f58f28b69&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing
Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort (:32), the agency’s efforts to help the clinical trial modeling and simulation industry (16:22), and the UK’s MHRA plan to use artificial intelligence to assist in drug application reviews (21:05).More On These Topics From The Pink Sheet US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes?: https://pink.citeline.com/PS150167/US-FDA-Adcomm-Reform-Does-Listening-Session-Suggest-No-Major-Near-Term-Changes US FDA Wants Advice About Advisory Committees: Try Having Some?: https://pink.citeline.com/PS154644/US-FDA-Wants-Advice-About-Advisory-Committees-Try-Having-Some US FDA Developing Model Master File System To Grow Modeling, Simulation Field: https://pink.citeline.com/PS154647/US-FDA-Developing-Model-Master-File-System-To-Grow-Modeling-Simulation-Field UK’s MHRA To Use AI In Regulatory Review Process & RWD Analysis: https://pink.citeline.com/PS154643/UKs-MHRA-To-Use-AI-In-Regulatory-Review-Process--RWD-Analysis
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s draft framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and Apple Watch’s new feature to help people with Parkinson’s disease.Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in this episode:BD’s CTO Beth McCombs Discusses Key Initiatives – AI/Gen AI; DE&I Strategy; Succession PlanningHSS Spine Surgeon Sees Potential For AI Chatbots, But Not To ‘Practice Medicine’ Philips Portfolio Includes ‘No Single Product That Does Not Use A Type of AI,’ Says CEO and AI Thought Leader Roy JakobsDiscreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple WatchCDHR’s AR/VR Home Space Will Serve As An ‘Idea Lab’ For Device Stakeholders
Flora and Emma are joined by Datamonitor’s CNS analysts Summer, Joseph, and Wen-Yu to discuss coverage from AAN.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 April 2024. In this episode: 2023’s top selling drugs and the COVID cliff; falling sales force Roche to reassess priorities; Phase III immunology win for Sanofi; BMS’s strong pipeline: and which companies could be acquired next.https://scrip.citeline.com/SC150182/Quick-Listen-Scrips-Five-MustKnow-Things
Learn how molecular technology is enhancing patient safety for CAR-T clinical trials. US FDA recently initiated class safety labeling changes after evaluating the safety of CAR-T cancer treatment therapies. What does this mean for developers in the CAR-T landscape? Listen to your free podcast to find out.Listen in on the conversation as experts from Cerba discuss facilitating patient safety measures in CAR-T therapies by accurately identifying the integration of viral vectors, utilizing flow cytometry, and more.Listen now as experts discuss answers to: · What patient monitoring is required by the FDA? · What molecular technology does Cerba use and how does it meet FDA requirements? · What is the importance of cytometry assays in monitoring CAR-T cells? · What are the opportunities for combining flow cytometry with genomic solutions? · What key innovations are poised to improve patient monitoring in clinical trials?
Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation (:34), upcoming guidance on accelerated approval for gene therapies (14:15), and partisan attacks on the agency from Capitol Hill (27:13).More On These Topics From The Pink SheetRx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says: https://pink.citeline.com/PS150143/Rx-Advertising-Interchangeability-Doesnt-Mean-Clinical-Superiority-To-Other-Biosimilars-FDA-Says US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios: https://pink.citeline.com/PS150140/US-FDA-Gene-Therapy-Accelerated-Approval-Guidance-Will-Describe-Buckets-Of-Use-Scenarios Partisan Politics Returns To US FDA Congressional Oversight: https://pink.citeline.com/PS150114/Partisan-Politics-Returns-To-US-FDA-Congressional-Oversight
Pulmonologist Bing Xue, MD, reviews the latest GOLD guidelines and discusses relevant topics regarding COPD treatment.
Join Scrip's China-based editors Brian Yang and Dexter Yan in this Chinese/English podcast as they look at data presented to AACR by Chinese pharma firms and recent acquisitions of China-based companies. UK-based writer Andrew McConaghie also joins to provide his perspectives, including on the proposed US BIOSECURE Act.https://scrip.citeline.com/SC150164/China-Biotech-Podcast-AACR-BIOSECURE-European-Perspectives
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.
Scrip's Joseph Haas, Kevin Grogan and Edwin Elmhirst talk about the biopharma M&A environment and which companies might look particularly appealing to potential acquirers.
In this episode of the In Vivo podcast, Eric Finzi, CEO of Healis Therapeutics, discusses how his company is targeting major depression, post-traumatic stress disorder and other mental illnesses using facial botox injections.
Helping Consumers ‘Tune In’ To Reliable Health Information, With Kaizo’s Anita Nahal“Consumers are rewriting the rules when it comes to where they are going for information and the type of information they are looking for,” reports Kaizo’s Anita Nahal, speaking to HBW Insight’s Over the Counter podcast about the agency’s latest Communicating Health Messages report. Trust in social media has increased, and personal beliefs and lived experiences are playing a larger role in shaping attitudes to health information, explains Nahal, who is director at the London-based PR agency. However, consumers are also continuing to “tune-out” from health messages and be less critical of sources. To help consumers navigate this new reality, consumer health companies need to adapt, rethink and reset their communication strategies, Nahal advises.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 19 April 2024. In this episode: Teva’s immunology biosimilar launches; Intra-Cellular’s promising depression data; Phase III sleep apnea win for Lilly’s tirzepatide; an interview with Viking’s CEO; and China looks to define innovative drugs.https://scrip.citeline.com/SC150134/Quick-Listen-Scrips-Five-MustKnow-ThingsOther podcasts in this series: https://on.soundcloud.com/xSKGyTJnAYS66apP9
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi (:28), Janet Woodcock’s new post-FDA role (12:28), and ongoing preparations for new pneumococcal vaccines that will reach the market soon (17:28).#business #pharmaMore On These Topics From The Pink SheetMedicare Spending Forecast For Leqembi Reflects CMS Angst About Alzheimer’s Drug Costs: https://pink.citeline.com/PS150095/Medicare-Spending-Forecast-For-Leqembi-Reflects-CMS-Angst-About-Alzheimers-Drug-CostsWoodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length: https://pink.citeline.com/PS150111/Woodcock-Takes-On-Rare-Disease-Challenges-In-Retirement-Keeps-FDA-Industry-At-Arms-Length Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116: https://pink.citeline.com/PS150029/Change-Is-Constant-For-Pneumococcal-Vaccines-US-CDC-Prepares-For-Mercks-V116
Scrip’s senior editor Vibha Ravi speaks with Jack Hoppin, CEO and chairman, and John Babich, chief scientific officer, at Ratio Therapeutics, about the company’s radiopharmaceuticals pipeline, investment by BMS, use of AI, trends and developments in radiopharma research like combining ADCs or PARP inhibitors and more.https://scrip.citeline.com/SC150098/Ratio-Therapeutics-On-BMS-Investment-Radiopharma-RD-Trends-AI-Use
In this Chinese- and English-language episode, guest speaker Treehill Partners co-founder Ali Parshadezah joins Brian Yang and Dexter Yan to discuss updates on the proposed US BIOSECURE Act and US-China biotech movements, including recent M&A activity.https://scrip.citeline.com/SC150090/China-Biotech-Podcast-BIOSECURE-Updates-GenmabProfound-Deal
Audio roundup of selected biopharma industry content from Scrip over the business week ended 12 April 2024. In this episode: the shifting sands of pharma R&D; big pharma oncology strategies; semaglutide’s promise in heart failure; AstraZeneca looks to multiple cancer modalities; and an interview with Astellas’s chief strategy officer.https://scrip.citeline.com/SC150097/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings (:36), agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans (20:52), and Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide getting reviewed (32:23).More On These Topics From The Pink SheetAdcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur: https://pink.citeline.com/PS150077/Adcomm-Open-Public-Hearings-Have-Become-Too-SponsorDriven--US-FDAs-Pazdur Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations: https://pink.citeline.com/PS150081/Clinical-Trial-Diversity-Requires-Sponsors-Work-With-An-Assortment-Of-Patient-Advocates-Community-Organizations Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger: https://pink.citeline.com/PS150070/Stealths-Elamipretide-Gets-US-FDA-Review-But-Same-Questions-Linger
In this episode, In Vivo speaks to 2024 Rising Leader Hanadie Yousef, CEO of Juvena Therapeutics, about her journey, the secretome as a source of therapeutics, longevity medicine and alternatives to GLP-1 inhibitors for obesity.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 5 April 2024. In this episode: Genmab buys into ADCs; Roivant set to take on AbbVie in uveitis; Ipsen signs firs ADC pact; South Korea looks to build biotech momentum; and the end of the road for Acorda.https://scrip.citeline.com/SC150062/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed (:32), an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees (9:08), and Japan’s PMDA opening an office in Washington D.C. (16:19).More On These Topics From The Pink SheetAmylyx’s Relyvrio Withdrawal May Trigger More Public Pledges Based On Confirmatory Trial Data: https://pink.citeline.com/PS150060/Amylyxs-Relyvrio-Withdrawal-May-Trigger-More-Public-Pledges-Based-On-Confirmatory-Trial-Data US FDA Envisions Advisory Committees For Allergy, Asthma Biomarkers With ‘Real Impact’: https://pink.citeline.com/PS149915/US-FDA-Envisions-Advisory-Committees-For-Allergy-Asthma-Biomarkers-With-Real-Impact Breaking Barriers: Japan's PMDA To Open First Global Office, In D.C.: https://pink.citeline.com/PS150044/Breaking-Barriers-Japans-PMDA-To-Open-First-Global-Office-In-DC
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.
기술 수요와 공급의 '불균형' 속에서 국내 ADC 업체들은 생태계를 발전시키려 노력하고 있습니다. Scrip의 정두영 피노바이오 대표 인터뷰기사를 요약한 내용입니다.https://scrip.citeline.com/SC149716/How-Pinotbio-Is-Helping-Build-Koreas-ADC-Ecosystem
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Merck & Co progresses cardiovascular strategy; Novo purchase builds heart failure presence; CRL setbacks for Regeneron; ITF faces challenging Duchenne field; and AbbVie needs to freshen up.https://scrip.citeline.com/SC150030/Quick-Listen-Scrips-Five-MustKnow-Things
In this episode, HBW Insight’s Europe and US editors Tom Gallen and Malcolm Spicer bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago, Kenvue, soon to celebrate its first anniversary as a new company; Sanofi, which has announced it will be exiting the OTC market by divesting its OTC business and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the possible advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.
Flora and Ian are joined by Datamonitor’s financial analyst Abby, who discusses the Inflation Reduction Act and drug pricing trends in the US.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: another big deal in radiopharmaceuticals; BioNTech’s ADC pipeline; China CDMOs embrace uncertain future; at look at the rivals in MASH; and industry views on how AI might be transformative.https://scrip.citeline.com/SC150008/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access (:34), the SCOTUS reaction to the fight against misinformation (18:28), and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews (31:23).More On These Topics From The Pink SheetMifepristone Supporters Highlight Voter Trust In FDA Decisions Ahead Of Supreme Court Arguments: https://pink.citeline.com/PS149998/Mifepristone-Supporters-Highlight-Voter-Trust-In-FDA-Decisions-Ahead-Of-Supreme-Court-Arguments US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments: https://pink.citeline.com/PS149985/US-FDAs-Anti-Misinformation-Campaigns-Look-Safer-After-Supreme-Court-Oral-Arguments The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews: https://pink.citeline.com/PS149961/The-Dog-That-Didnt-Bark-ODAC-Gives-Nod-To-Three-Products-Despite-Negative-FDA-Reviews Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts: https://pink.citeline.com/PS149995/Eye-On-ODAC-Former-Members-FDAs-Pazdur-Talk-PreMeeting-Mindsets-Impact-Of-Sponsors-Experts
Guest speaker Kevin Duan joins Brian Yang and Dexter Yan to discuss the proposed US BIOSECURE Act, the US FDA's approval of a China-origin anti-PD-1 drug and the latest developments in the antibody-drug conjugate area.
Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in this episode:In Five Years, People Will Navigate Their Health Care With An AI-Advisor – Verily’s Andrew TristerVerily’s Andrew Trister On Uniting The Pieces To Create Personalized Health, EquityEuropean Parliament Adopts AI Act, But Success Hangs On The AI OfficeAI Clinical Summarization Tools Sit In 'Regulatory Grey Area', Experts Warn
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Galderma prepares to take on Dupixent; Pfizer’s plans for Adcetris in DLBCL; Lilly’s donanemab approval delayed again; the psychedelic R&D pipeline; and an interview with BMS’s CDTO Greg Meyers.https://scrip.citeline.com/SC149962/Quick-Listen-Scrips-Five-MustKnow-Things
Summary: 今回取り上げた記事はこちら「MindMed Ready To Take LSD Therapy Into Phase III For Anxiety（MindMed、LSD療法を不安症治療の第III相治験へ）」https://www.citeline.com/ja-jp/resources/mindmed-ready-to-take-lsd-therapy-into-phase-iii-for-anxiety※全文の閲覧には情報の登録（無料）が必要です。世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。(英語版)https://scrip.citeline.com/SC149912/MindMed-Ready-To-Take-LSD-Therapy-Into-Phase-III-For-Anxiety※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip
Vibhor Gupta, director and founder of Pangaea Data, talks to In Vivo about the value of identifying the 80% of patients with undiagnosed or misdiagnosed conditions, and how his company is addressing this need.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer won’t split, for now; Pfizer’s next-gen ADC pipeline; oncology dominates investment but other areas grow; goodbye NASH, hello MASH; and BMS’s CEO gives his views on India.Links to the stories discussed are here: https://scrip.citeline.com/SC149924/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss Vanda’s decision to sue the FDA over the rejection of the Hetlioz jet lag indication (:30), Mark Cuban’s comments at a White House event that the federal government and others should stop doing business with the big three PBMs (11:50), and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill (24:49).More On These Topics From The Pink SheetVanda Appeals FDA’s Denial Of Hetlioz Jet Lag Application As It Is Hit With CRL For Insomnia: https://pink.citeline.com/PS149914/Vanda-Appeals-FDAs-Denial-Of-Hetlioz-Jet-Lag-Application-As-It-Is-Hit-With-CRL-For-Insomnia Mark Cuban: Pharma’s Secret Weapon In The Fight Against PBMs: https://pink.citeline.com/PS149899/Mark-Cuban-Pharmas-Secret-Weapon-In-The-Fight-Against-PBMs Congress Gives US FDA Austere Budget But Seeks Boosts On Inspections, IT, And ALS Activities: https://pink.citeline.com/PS149897/Congress-Gives-US-FDA-Austere-Budget-But-Seeks-Boosts-On-Inspections-IT-And-ALS-Activities
2024년 글로벌 전문가들이 예측하는 치료영역의 발전은 무엇인 지에 대한 Scrip 기사를 요약한 내용입니다https://scrip.citeline.com/SC149780/Scrip-AsksWhat-Does-2024-Hold-For-Biopharma-Part-6-Therapeutic-Area-Advances
In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: optimistic outlook for biopharma IPOs; Boehringer’s promising MASH results; Viking emerges as obesity contender; Incyte looks to portfolio diversification; and a look at China’s HPV vaccine market.https://scrip.citeline.com/SC149879/Quick-Listen-Scrips-Five-MustKnow-Things
iRhythm CEO Quentin Blackford returns to Medtech Insight’s Cardio Conversations podcast to talk about the launch of the company’s new Monitor long-term cardiac monitoring patch, the company's plans for the MCT market, and a lot more.
In this episode of Over the Counter, HBW Insight speaks to Paul LaTerra, Director, R&D, Global Hair and Scalp for Kenvue, a New Jersey-based consumer health company that markets skin care brands Neutrogena, Aveeno and Lubriderm. We discuss growth of the beauty-from-within supplements market, how the products complement topical skin care and hair formulas and the growing body of research demonstrating significant skin and hair health benefits.
Emma and Flora outline expected trends and exciting upcoming events across therapy areas for 2024, straight from the subject matter experts at Datamonitor.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Alan Watt, CEO of NodThera, a clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases, talks to In Vivo about the company’s pipeline and recent data publication in the field of obesity. The company is focused on developing drugs that inhibit the NLRP3 inflammasome, a validated drug target that plays a pivotal role in controlling inflammatory diseases. It has two clinical trials ongoing – both Phase Ib/IIa – in Parkinson’s disease and for cardiovascular risk in obese patients.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer takes strategic steps to cut debt; AbbVie confirms internal appointment as CEO; another RIPK1 setback for Denali/Sanofi; new biotech reality in China; and ex-Daiichi Sankyo CEO shares insights into tough decisions.https://scrip.citeline.com/SC149846/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs (:25), whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published (16:32), and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee (27:19).More On These Topics From The Pink SheetLykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance: https://pink.citeline.com/PS149813/Lykos-MDMA-NDA-Leads-Upcoming-Tests-Of-US-FDAs-Psychedelics-Draft-Guidance For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards: https://pink.citeline.com/PS149812/For-Psychedelics-US-FDA-Is-Open-To-Creative-Thinking-But-Firm-On-Approval-Standards A Visual Trip Through The Psychedelic Pipeline: https://pink.citeline.com/PS149831/A-Visual-Trip-Through-The-Psychedelic-Pipeline Aduhelm’s Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH: https://pink.citeline.com/PS149826/Aduhelms-Post-Marketing-Studies-At-Least-One-More-Data-Dump-Likely-Required-By-NIH New US FDA Genetic Metabolic Adcomm Needs More Candidates: https://pink.citeline.com/PS149819/New-US-FDA-Genetic-Metabolic-Adcomm-Needs-More-Candidates
The Association of the European Self-Care Industry celebrates its 60th birthday this year. In this episode, we catch up with AESGP director general, Jurate Švarcaite, to find out how the association will mark the occasion, including at this year’s Annual Meeting in Brussels in June. AESGP Annual Meetings are an excellent way to find out what the key issues and trends are impacting the European consumer health industry, and this one will be no different. We talk through some of the key themes of this year’s conference. Sustainability continues to be a mega-trend, closely followed by digitalization and artificial intelligence. With its wide-ranging footprint across OTC medicines, food supplements and self-care medical devices sectors, the consumer health industry is facing an avalanche of regulations, and the AESGP continues to be an effective advocate for its stakeholders, alongside adjacent industry partners.
Pink Sheet reporters and editors discuss the dismissal of PhRMA’s suit challenging the Medicare price negotiation provisions (:30), the US FTC and HHS investigation of drug shortages (12:01), and the potential for FDA-approved marijuana products (23:47).More On These Topics From The Pink SheetPhRMA’s Lawsuit Against Medicare Trips Over ‘Administrative Remedy’ Standard; Will Others? https://pink.citeline.com/PS149791/PhRMAs-Lawsuit-Against-Medicare-Trips-Over-Administrative-Remedy-Standard-Will-Others FTC, HHS Probe GPO Contracting Practices As Source Of Generic Drug Shortages: https://pink.citeline.com/PS149790/FTC-HHS-Probe-GPO-Contracting-Practices-As-Source-Of-Generic-Drug-Shortages Prescription Marijuana? FDA Rescheduling Memo Sets Stage To Test Whether There’s A Viable Market: https://pink.citeline.com/PS149781/Prescription-Marijuana-FDA-Rescheduling-Memo-Sets-Stage-To-Test-Whether-Theres-A-Viable-Market
Pink Sheet reporter and editors discuss the issues and concerns raised during a major generic industry conference (:42), former FDA Commissioner Scott Gottlieb’s views on what a second Trump term as president would mean for the agency (13:54), and congressional hearings on FDA foreign manufacturing facility inspections and drug shortages (23:51).More On These Topics From The Pink Sheet‘We Did Too Good Of A Job’ On Lowering Prices: Sandoz’s Haruvi Discusses Generic Sustainability: https://pink.citeline.com/PS149745/We-Did-Too-Good-Of-A-Job-On-Lowering-Prices-Sandozs-Haruvi-Discusses-Generic-Sustainability Blue Shield Of California’s Pharmacy Benefit Overhaul Could Still See Boost From Transparency Legislation: https://pink.citeline.com/PS149751/Blue-Shield-Of-Californias-Pharmacy-Benefit-Overhaul-Could-Still-See-Boost-From-Transparency-Legislation Gottlieb: FDA Would Be Subject To More White House Control Under A Second Trump Term: https://pink.citeline.com/PS149737/Gottlieb-FDA-Would-Be-Subject-To-More-White-House-Control-Under-A-Second-Trump-Term Congress Explores Plans For Catching Up On US FDA Foreign Inspections: https://pink.citeline.com/PS149744/Congress-Explores-Plans-For-Catching-Up-On-US-FDA-Foreign-Inspections Environmental Regulations May Create Barriers To Onshoring More Rx Manufacturing: https://pink.citeline.com/PS149749/Environmental-Regulations-May-Create-Barriers-To-Onshoring-More-Rx-Manufacturing
Brian Yang, Dexter Yan and UK-based Kevin Grogan discuss Shanghai's new policy, draft US Biosecure bill, and multinationals AstraZeneca and Sanofi executives' views on China and Chinese innovation, along with other challenges.https://scrip.citeline.com/SC149758/China-Biotech-Podcast-Shanghai-Policy-US-Draft-Biosecure-Bill-MNCs-China-Strategy
박민수 보건복지부 2차관은 Citeline의 Pink Sheet과의 인터뷰에서 정부의 혁신적 R&D 우선순위와 이같은 목표 달성을 위한 과제, 바이오산업 투자심리 악화에 대한 대응책, 신약 개발 지원을 위한 규제 변화 등 다양한 이슈에 대해 이야기했습니다.https://pink.citeline.com/PS149348/Koreas-Powerhouse-Ambitions-Build-On-Innovation-Fostering-Policies
During this episode, Barnaby Pickering is joined by Rollie Carlson, CEO of Immunexpress, developer of Septicyte, a test for sepsis, Mark McDonough, CEO of ChromaCode, a company developing multiple blood-based tests for cancer diagnosis and treatment, with its first being in non-small cell lung cancer, and Lishan Aklog, CEO of Lucid Diagnostics, who have developed a cell-collection method that aims to bring forward the stage at which oesophageal cancer can be diagnosed.The group discuss the companies’ products and why they are transformative, as well as the upcoming regulatory and commercial hurdles awaiting diagnostics companies.
Xiaodong Wang of major Chinese pharma firm BeiGene and China's National Institute of Biological Sciences shares views on China biotech innovation, BeiGene and next big thing with Scrip's Brian Yang.
HBW Insight continues its conversation with The Exponential Club’s Nick Tate. In this episode, we discuss what the future of consumer health might actually look like, covering a lot of ground from nudge-based health insurance platforms to digital products that may supplement or even replace traditional medicines. We also talk about the promise and limitations of at-home testing for furthering personalisation, and how to navigate partnerships with tech-specialists large and small to help accelerate digital transformation plans.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: the biggest drug launches expected in 2024; Roche’s Pharma CEO talks about growth momentum; 10 pivotal studies to look out for this year; the obesity market now and in future; and what does 2024 hold for transformative technology in biopharma.https://scrip.citeline.com/SC149742/Quick-Listen-Scrips-Five-MustKnow-Things
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with industry leaders in medtech and healthtech and demos of some of the most innovative tech seen at CES 2024 in Las Vegas. Hannah Daniel dives into the latest developments in the intellectual property dispute between Apple and Masimo over blood oxygen sensors in the newer Apple Watch models. Medtech Insight articles addressing topics discussed in this episode:Dexcom COO On Stelo CGM Plans, Apple Watch Developments, And Why Non-Invasive Glucose Monitoring Still Leaves Much To Desire Abbott Lingo Leaders On Consumer Biowearable Outlook: ‘A Lot Of Appetite For Glucose As A Biomarker For Your Health’CES Roundup: Holoportation, Empathic Robot, Aging Suit, Bionic Prosthetic Arm, Headband For Better Sleep Roundup: AI-Powered Assistive Hearing Devices Scream With Personalization; Femtech From Baby Makers To Menopause Apple Watches Are Back On The US MarketNews We’re Watching: Apple/Masimo Patent Fight UpdateApple Drops Pulse Oximeter Features To Subvert Import Ban
In the latest episode of the In Vivo podcast, Edwin Stone, CEO of UK-based Cellular Origins, talks about how robotics can increase access to safe cellular therapies. The type of biology-agnostic robotics his company develops can help companies scale up cell manufacturing while lowering the cost of production.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer’s pipeline refresh; J&J’s selective pharma M&A approach; silver lining for Gilead’s Trodelvy miss?; paying for obesity drugs; and the story behind Vertex and CRISPR’s gene therapy breakthrough.https://scrip.citeline.com/SC149699/Quick-Listen-Scrips-Five-MustKnow-Things
Medtech Insight regulatory reporter Hannah Daniel speaks to Sanjay Voleti, AliveCor’s chief business officer, about his company’s patent infringement case against Apple and what it’s like to take on a tech giant over intellectual property.
Pink Sheet reporters and editor discuss FDA Principal Deputy Commissioner Janet Woodcock’s place in the pantheon of FDA leaders (:27), an agency meeting with stakeholders on puberty blockers (23:55), and a new boxed warning for CAR-T therapies (35:42).More On These Topics From The Pink SheetImmortalizing Janet Woodcock: https://pink.citeline.com/PS149666/Immortalizing-Janet-Woodcock On Puberty Blockers, FDA Is In ‘Listen Only’ Mode – For Now: https://pink.citeline.com/PS149679/On-Puberty-Blockers-FDA-Is-In-Listen-Only-Mode--For-Now CAR-Ts Getting Boxed Warning On Secondary Malignancies Despite Sponsor Causation Questions: https://pink.citeline.com/PS149673/CAR-Ts-Getting-Boxed-Warning-On-Secondary-Malignancies-Despite-Sponsor-Causation-Questions Kite’s Tecartus Boxed Warning Will More Closely Resemble Other CAR-Ts After FDA Changes Course: https://pink.citeline.com/PS149680/Kites-Tecartus-Boxed-Warning-Will-More-Closely-Resemble-Other-CAR-Ts-After-FDA-Changes-Course
In this discussion, Dr. Fleming provides expert insight to questions about treating LBCL in elderly patients and those with comorbidities.
Pink Sheet reporters and editors discuss the nearly wide open 2024 FDA advisory committee calendar, CMS’s impact on Florida’s drug importation plan, and the FDA’s many missed user fee goals in 2023.More On These Topics From The Pink SheetThe Sudden Stop In US FDA Advisory Committees: https://pink.citeline.com/PS149641/The-Sudden-Stop-In-US-FDA-Advisory-Committees Drug Importation And Medicaid: Trump Era Guidance Likely Disincentivizes Use: https://pink.citeline.com/PS149635/Drug-Importation-And-Medicaid-Trump-Era-Guidance-Likely-Disincentivizes-Use US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19: https://pink.citeline.com/PS149629/US-FDAs-Missed-User-Fee-Goals-Spiked-In-2023--And-Not-Just-Because-Of-COVID-19
VelaVigo founder and CEO Jing Li in Shanghai joins guest speaker Leon Tang in the US and Brian Yang in Beijing to discuss what stood out in this special JPM-focused episode of Scrip's Chinese-language podcast. https://scrip.citeline.com/SC149656/ChineseLanguage-Podcast-JPM-China-Biotech-Going-Global-2024-Outlook#pharma #biotech #JPM2024 #China #lifesciences
（日本語版）今回取り上げた記事はこちら 「J.P. Morgan 2024: Optimism With An Undercurrent Of Tension（J.P.モルガン2024年：緊張をはらんだ楽観論）」 https://www.citeline.com/ja-jp/resources/jp-morgan-2024-optimism-with-an-undercurrent-of-tension※全文の閲覧には情報の登録（無料）が必要です。世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 （英語版）https://scrip.citeline.com/SC149614/JP-Morgan-2024-Optimism-With-An-Undercurrent-Of-Tension ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: major takeaways and highlights from the J.P. Morgan meeting; J&J bets on ADCs with Ambrx buy; the Indian GLP-1 battleground; and Scrip asks what 2024 holds for business strategy and leadership.https://scrip.citeline.com/SC149628/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporter and editors discuss a new pilot project allowing collaborative reviews of gene therapies by multiple regulators (:42), predictions for the upcoming year by current and former US FDA leaders (11:12), and the FDA commissioner’s take on artificial intelligence (21:23).More On These Topics From The Pink SheetDon’t Call It Project Orbis: CoGenT Global Will Pilot Collaborative Review Of Gene Therapies: https://pink.citeline.com/PS149607/Dont-Call-It-Project-Orbis-CoGenT-Global-Will-Pilot-Collaborative-Review-Of-Gene-Therapies EMA To Become Observer Of FDA’s Project Orbis Early This Year: https://pink.citeline.com/PS149579/EMA-To-Become-Observer-Of-FDAs-Project-Orbis-Early-This-Year New Year’s Predictions From FDA Leadership Past And Present: GLP-1s, Mental Health, Big Data: https://pink.citeline.com/PS149583/New-Years-Predictions-From-FDA-Leadership-Past-And-Present-GLP1s-Mental-Health-Big-Data US FDA’s Role In Artificial Intelligence/Machine Learning Development Is ‘Convener,’ Califf Says: https://pink.citeline.com/PS149608/US-FDAs-Role-In-Artificial-IntelligenceMachine-Learning-Development-Is-Convener-Califf-Says
In the latest episode of the In Vivo podcast, non-executive chair Peter Bains and Owain Millington, vice president of immunology and head of preclinical, discuss ILC Therapeutics’ platform technology, financing plans as well as the pros and cons of running a startup biotech in the UK.
Join Jung Won Shin for this Korean-language mini podcast talking about a report from Citeline's Datamonitor Healthcare. Datamonitor Healthcare의 비만치료제시장 분석리포트를 요약한 내용입니다.https://www.biomedtracker.com/reportdetail.cfm?reportid=863
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: 2023 drug launch highlights; the M&A outlook for the new year; AstraZeneca’s China cell therapy acquisition; the pre-Christmas deal flow; and India at a turning point for ADCs?https://scrip.citeline.com/SC149606/Quick-Listen-Scrips-Five-MustKnow-Things
Listen as Chris Smyth, President, ICON Biotech Solutions discusses current trends in the biotech landscape, and predictions for future innovation, regulation and globalisation in this space. Recorded on Wednesday 15th November.
One week into 2024, there have already been multiple deals between Chinese innovative drug developers and multinational and the significant acquisition of GracellBio by AstraZeneca. Brian Yang and Dexter Yan invite guest speaker Liu Liu to discuss reasons behind the particularly active deal-making scene in the China biotech sector.https://scrip.citeline.com/SC149598/Chinese-Language-Podcast--AZMNC2024
In this edition of Cardio Conversations, Medtech Insight editor Reed Miller talked to Robert Chisena, the co-founder and CTO of AVS. He talked about the company's novel interventional technology for calcified peripheral arterial disease and how the company came together during the pandemic.Further Readinghttps://medtech.citeline.com/MT148128/Shockwave-Begins-First-All-Female-Study-Of-Coronary-Interventionshttps://medtech.citeline.com/MT147704/Reimbursement-For-Shockwaves-IVL-Device-May-Pose-Quandary-For-CMShttps://medtech.citeline.com/MT147623/Abbott-Buys-CSI-To-Add-Peripheral-And-Coronary-Atherectomy-Technologieshttps://medtech.citeline.com/MT147548/Shockwave-Buys-Neovasc-Hoping-Reducer-Angina-Device-Complements-Coronary-Lithotripsyhttps://medtech.citeline.com/MT143510/FDA-Approves-Shockwave-Coronary-Intravascular-Lithotripsy-SystemFurther ListeningThe full recording of this podcast, as well as all of our other Citeline podcasts, are available on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider.
Pink Sheet reporter and editors discuss key US and EU legislation that impacted 2023 and how it also could affect 2024, including EU legislative reform (:56), US Medicare drug price negotiations (14:43), and the US Food and Drug Administration user fee reauthorization (30:57).More On These Topics From The Pink SheetEuropean Commission Explains Impact Of EU Pharma Review On SMEs & Non-Profit Entities: https://pink.citeline.com/PS149505/European-Commission-Explains-Impact-Of-EU-Pharma-Review-On-SMEs--NonProfit-Entities Biopharma’s Prospects Under A Second Trump Term: They Can’t Get Much Worse: https://pink.citeline.com/PS149562/Biopharmas-Prospects-Under-A-Second-Trump-Term-They-Cant-Get-Much-Worse The following special topic pages include links to all of our coverage:EU Legislative Reform: https://pink.citeline.com/eu-legislative-reformFDA User Fees: https://pink.citeline.com/us-fda-user-feesDrug Pricing Debate: https://pink.citeline.com/pricing-debate
Join us for an insightful Q&A session with Dr. Vega, where we delve into the groundbreaking world of Multi-Cancer Early Detection (MCED) and the future of cancer detection.
In this episode, In Vivo speaks to Bruce Leuchter, CEO of Neurvati Neurosciences, about ways clinical drug development in rare neurologic diseases is being held back and what can be done to make the process more efficient and successful.
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says（邦題意訳：FDA、被験者の多様性を義務化へ がん治験では課題も）」 https://pink.citeline.com/PS149444/Clinical-Trial-Diversity-Plans-Early-Oncology-Experience-Shows-More-Work-Needed-US-FDA-Says世界の薬事規制ニュースPink Sheet（ピンクシート）とは？https://www.citeline.com/ja-jp/products-services/regulatory-and-compliance/pink-sheet
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to King & Spalding’s Eric Henry about the year’s most influential digital health regulations in the US and EU, and what we may have missed in all the excitement.
In this podcast Scrip looks at the some upcoming clinical catalysts for biopharma, judged by the size of the sales forecasts at stake. Companies including Sanofi, Cytokinetics, Corcept and Inventiva stand to gain – or lose.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: first ever gene editing FDA nod; US FTC ruffles pharma’s feathers; AstraZeneca pays to play in RSV; Syndax leukemia drug makes splash at ASH; BMS bets big on Chinese ADC.https://scrip.citeline.com/SC149527/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors in the US and Europe consider the growth and impact of Project Orbis after a year in which two major regulators joined the program, but several countries did not keep up with the US approval pace.More On These Topics From The Pink SheetProject Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind: https://pink.citeline.com/PS149452/Project-Orbis-2023-FDA-Approves-Six-New-Cancer-Drugs-But-Partner-Nations-Lag-Behind Project Orbis: More Cancer Drugs Available In Scotland Than England: https://pink.citeline.com/PS149063/Project-Orbis-More-Cancer-Drugs-Available-In-Scotland-Than-England EMA Will Observe Project Orbis In Effort To Increase Collaboration: https://pink.citeline.com/PS148458/EMA-Will-Observe-Project-Orbis-In-Effort-To-Increase-Collaboration US FDA Eyes Project Orbis-Type Approach For Cell And Gene Therapies: https://pink.citeline.com/PS147730/US-FDA-Eyes-Project-Orbis-Type-Approach-For-Cell-And-Gene-Therapies
Brian Yang and Dexter Yan discuss Biokin/BMS's ADC deal, WuXi Biologics' share price drop, BlissBio's recent developments and Pfizer's divestment of Prevenar 13 commercial rights in China to a Chinese local partner.https://scrip.citeline.com/SC149497/Chinese-Language-Podcast-BiokinBMS-Deal-Developments-At-Pfizer-BlissBio-WuXi-Biologics
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: another acquisition for AbbVie; Roche buys into the obesity market; J&J’s oral immunology push; oral incretins advance; and AstraZeneca on Chinese innovation.https://scrip.citeline.com/SC149480/Quick-Listen-Scrips-Five-MustKnow-Things
In this episode, HBW Insight speaks to Aurélie Perrichet, regional director, Europe at the International Fragrance Association. We discussed the implications of planned revisions to the European Commission’s Classification, Labeling and Packaging (CLP) regulation, which may re-categorize biological materials as mixtures, from their current status as substances. Perrichet also speculated how the proposed change could reduce the number of available essential oils and other types of fragrance and flavor materials available.
최근 제프리스 헬스케어 컨퍼런스에서 발표된 제약바이오산업의 생성형인공지능 적용사례에 대한 Scrip 기사를 요약한 내용입니다.https://scrip.citeline.com/SC149412/As-Biopharma-Adopts-Generative-AI-The-People-Element-Is-Crucial-To-Success
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: CAR-Ts and malignancies; comeback for GSK’s Blenrep?; Novartis’s pipeline cull; FGF21 analogs in NASH; and a call to action from the Scrip Awards Lifetime Achievement winner.https://scrip.citeline.com/SC149443/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies (:35), the agency’s policy for using background music in direct-to-consumer advertising (7:27), and the FDA’s new incoming principal deputy commissioner (13:44).More On These Topics From The Pink SheetCAR-T Malignancy Reports Could Temper Excitement For Use Beyond Oncology: https://pink.citeline.com/PS149420/CAR-T-Malignancy-Reports-Could-Temper-Excitement-For-Use-Beyond-Oncology Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy: https://pink.citeline.com/PS149411/Background-Music-During-Risk-Segment-Of-Rx-Drug-Ads-FDA-Explains-Its-Policy US FDA Chief Scientist Bumpus Will Become Principal Deputy Commissioner: https://pink.citeline.com/PS149428/US-FDA-Chief-Scientist-Bumpus-Will-Become-Principal-Deputy-Commissioner
In this podcast, In Vivo speaks to Sara Barrington, CEO of Verici DX. During the discussion, Barrington outlines the current challenges facing patients post-transplant, why current diagnostics are inadequate, and where the overall transplant market is headed, considering the rise of home dialysis and the potential future for xenotransplants.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer’s Phase III failure; US group seeks Japan changes; AstraZeneca winning AKT race for now; NASH developments at AASLD; and the Q3 impact of China’s corruption campaign.https://scrip.citeline.com/SC149413/Quick-Listen-Scrips-Five-MustKnow-Things
Datamonitor Healthcare’s Epidemiology team (Ridwaan Ibrahim, Lucia Rodriguez-Garcia, Maya Trivedy, and Asma Ali) discuss the current trends in epidemiology throughout the world, and how epidemiology data is being used to support drug discovery and improve health outcomes. Topics discussed include epidemiology methodologies, Alzheimer’s Disease, non-communicable diseases in Africa, genetic epidemiology, pollution, and increasing cancer rates.Other platformsApple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
In accepting Scrip’s Lifetime Achievement Award, Ovid Therapeutics’ CEO called on pharma to show responsible leadership and live up to its potential to do good for society.
Brian Yang and Dexter Yan discuss the FDA approval of Chinese PD-1, Sanofi BioMap AI deal, Third quarter earnings and Biden-Xi Summit and US-China regulatory dialogue.
In this podcast, Medtech Insight speaks to Andy Molnar, CEO of the digital therapeutics alliance; Joel Morse, CEO and co-founder of Curavit and Owen McCarthy, CEO and co-founder of MedRhythyms. The trio discuss the current situation surrounding digital therapeutics, and where they believe they are headed in the coming years.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.Medtech Insight articles addressing topics discussed in this episode:Can Digital Twin Technology Help Beat Chronic Disease? Twin Health Is Getting Users Hooked, And Off Their Medshttps://medtech.citeline.com/MT148407/Can-Digital-Twin-Technology-Help-Beat-Chronic-Disease-Twin-Health-Is-Getting-Users-Hooked-And-Off-Their-MedsAbbott’s Metabolic Biowearable Gets ‘Extremely Positive’ UK Reception; Next Up, US Filinghttps://medtech.citeline.com/MT148365/Abbotts-Metabolic-Biowearable-Gets-Extremely-Positive-UK-Reception-Next-Up-US-FilingAfter Two-Year Delay, J&J Plans To Start Trial Ottava Surgical Robot In 2024https://medtech.citeline.com/MT148422/After-TwoYear-Delay-JJ-Plans-To-Start-Trial-Ottava-Surgical-Robot-In-2024Leo Grady’s Jona Hopes To Repair Microbiome Testing’s Murky Reputationhttps://medtech.citeline.com/MT148403/Leo-Gradys-Jona-Hopes-To-Repair-Microbiome-Testings-Murky-ReputationInvesting In Digital: Slow And Steady May Win This Racehttps://invivo.citeline.com/IV148596/Investing-In-Digital-Slow-And-Steady-May-Win-This-Race
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: AstraZeneca CEO on obesity and more; biotech’s rollercoaster ride set to continue; new Wegovy data; Novo’s plans for semaglutide in NASH; and Zepbound set to become biggest drug ever?https://scrip.citeline.com/SC149388/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches (:42), the stance of the FDA’s oncology division on confirming benefit after an accelerated approval (16:59), and why formal meetings between the agency and sponsors cannot be recorded (36:51).More On These Topics From The Pink SheetWith Woodcock’s Retirement, US FDA Loses A Renaissance Woman: https://pink.citeline.com/PS149368/With-Woodcocks-Retirement-US-FDA-Loses-A-Renaissance-WomanConfirmatory Trial Plan For Acrotech’s Folotyn, Beleodaq Needs Rethinking, FDA Panel Says: https://pink.citeline.com/PS149361/Confirmatory-Trial-Plan-For-Acrotechs-Folotyn-Beleodaq-Needs-Rethinking-FDA-Panel-SaysFDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials: https://pink.citeline.com/PS149353/FDA-Panel-To-Consider-Strategies-For-Timely-Completion-Of-Accelerated-Approval-Confirmatory-TrialsAccelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials: https://pink.citeline.com/PS149359/Accelerated-Approval-US-FDA-Writing-Guidance-On-What-Ongoing-Means-For-Confirmatory-TrialsAccelerated Approval: Acrotech’s Confirmatory Trial For Folotyn, Beleodaq More Than A Decade Behind Schedule: https://pink.citeline.com/PS149342/Accelerated-Approval-Acrotechs-Confirmatory-Trial-For-Folotyn-Beleodaq-More-Than-A-Decade-Behind-ScheduleMinutes Matter: Why The US FDA Refuses To Record Formal Meetings: https://pink.citeline.com/PS149310/Minutes-Matter-Why-The-US-FDA-Refuses-To-Record-Formal-Meetings
Syngene’s MD & CEO, Jonathan Hunt, in an interview with Scrip, dissects trends and opportunities in the CRDMO segment as US biotechs slow their burn rate amid a funding squeeze while other large and medium-sized biopharma firms seek to rebalance their supply chain. The Indian firm’s ability to add value in the development and manufacture of ADCs and also its partnership with Amgen are some of the other topics the ex-AstraZeneca executive discusses.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: US approval for Lilly’s obesity drug; a look at the future of the obesity market; BMS’s ADC deal; Roche’s MS plans; and one Chinese firm’s CAR-T plans.https://scrip.citeline.com/SC149349/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporter and editors discuss the FTC’s challenges of Orange Book patents (:35), DTC promotion practices as part of acquisition due diligence (12:39), and how Intarcia’s advisory committee decision appeal could play out (19:06). More On These Topics From The Pink Sheet In Swift Challenge To Orange Book Patent Listings, Federal Trade Commission Fills FDA Ministerial Gap: https://pink.citeline.com/PS149316/In-Swift-Challenge-To-Orange-Book-Patent-Listings-Federal-Trade-Commission-Fills-FDA-Ministerial-GapRx Ad/Promo Practices Should Be Part Of Acquisition Due Diligence, DoJ Official Says: https://pink.citeline.com/PS149309/Rx-AdPromo-Practices-Should-Be-Part-Of-Acquisition-Due-Diligence-DoJ-Official-SaysIntarcia Appeals Advisory Committee On Diabetes Drug-Device Combo, Claiming ‘Misrepresentation’: https://pink.citeline.com/PS149311/Intarcia-Appeals-Advisory-Committee-On-Diabetes-DrugDevice-Combo-Claiming-Misrepresentation
In this episode, HBW Insight speaks to Simon-Kucher & Partners about the latest trends in preventative consumer health. Partner Christian Rebholz and senior director Lorenzo Eandi explain the findings from the company’s recently published Better Health Report, which reached out to almost 3,000 consumers from across the world. We take a deeper dive into Brazil, where consumers are spending more on than average on preventative health, and Germany, where consumers are spending less but are turning to digital tools thanks to government support. We also find out what consumer health companies can do to respond to a growing awareness of mental health, especially among women and the younger generation.
Humira Biosimilar LandscapeOther platformsApple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
일본 최대 제약바이오 R&D 허브와 한국 바이오벤처들이 세포유전자치료제 분야의 협업을 활발히 추진하고 있다는 Scrip 기사를 요약한 내용입니다.https://scrip.citeline.com/SC149214/Japans-Largest-Biocluster-Korean-Ventures-To-Collaborate-For-Cell-And-Gene-Therapies
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: CEOs on global tensions; Roche’s new Alzheimer's contender; Sanofi eyes external deals; investors’ reactions to clinical data; and Korean licensing pitfallshttps://scrip.citeline.com/SC149308/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss take-aways from the first Medicare price negotiation program public listening sessions (:35), next steps after Sarepta reported questionable top-line data for its Duchenne muscular dystrophy gene therapy Elevidys (14:45), and indications the FDA may adjust its regulatory approach to gene editing products (26:27).More On These Topics From The Pink SheetCould Government Negotiated Prices Curtail Access? PBMs And Potential Perverse Incentives Dominate First Medicare Listening Session: https://pink.citeline.com/PS149097/Could-Government-Negotiated-Prices-Curtail-Access-PBMs-And-Potential-Perverse-Incentives-Dominate-First-Medicare-Listening-SessionElevidys And The EMBARK Trial: Is Another Advisory Committee Meeting Coming? https://pink.citeline.com/PS149282/Elevidys-And-The-EMBARK-Trial-Is-Another-Advisory-Committee-Meeting-Coming US FDA’s Confidence In Gene Editing Safety Growing Enough That Regulatory Bar May Be Lowered: https://pink.citeline.com/PS149289/US-FDAs-Confidence-In-Gene-Editing-Safety-Growing-Enough-That-Regulatory-Bar-May-Be-LoweredHeritable Genetic Modification Debate May Ignite Again As Technology Advances: https://pink.citeline.com/PS149098/Heritable-Genetic-Modification-Debate-May-Ignite-Again-As-Technology-Advances
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「Swiss To Introduce Parallel HTA & Regulatory Submissions, More Transparent Decisions（邦題意訳：新たな制度を導入のスイス、医薬品審査の透明性確保へ）」https://pink.citeline.com/PS149096/Swiss-To-Introduce-Parallel-HTA--Regulatory-Submissions-More-Transparent-Decisions世界の薬事規制ニュースPink Sheet（ピンクシート）とは？https://www.citeline.com/ja-jp/products-services/regulatory-and-compliance/pink-sheet
Listen in as Citeline sits down with a regulatory and compliance expert Mai Mishir, Senior Director, Global Regulatory Affairs from Advanced Clinical. Capture new insights into the present state of regulatory as advancements in technology, a shift to patient-centricity, and the globalization of clinical trials combine to change workflows and trial design. Plan your strategy now and develop new ways to master these complexities, with information from this free podcast.
Brian Yang interviews Nasdaq-listed cell therapy developer Gracell Bio Founder and CEO William Wei Cao who discussed the plan to enter the US market through quicker turnaround, faster delivery, cost-effective and safety profile. He also discussed taking the Shanghai-based firm’s CD19 and BCMA-dual targeted therapy to the first-line treatment, allogenic CAR-T therapies, combinations, Chinese biotech going global and surviving in the current “capital winter” environment.
In this Chinese-language podcast, Brian Yang and Dexter Yan discuss China biotech topics including the annual IND and NDA report from Center for Drug Evaluation, ESMO’s China data and Shanghai International Biotech Industry Week.https://scrip.citeline.com/SC149259/Chinese-Language-Podcast-ESMO-China-Data-Annual-CDE-Report-Shanghai-Biotech-Week
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: did Pfizer miss out on Roivant/Roche deal?; Padcev/Keytruda combo impresses in bladder cancer at ESMO; biggest upfront ever in Daiichi/Merck deal; Rybrevant at ESMO; and subcutaneous Leqembi could open up access.https://scrip.citeline.com/SC149266/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss new off-label use communications guidance (:35), how price negotiations could impact prescribing (9:49), and Monica Bertagnolli’s nomination for NIH director advancing (17:18).More On These Topics From The Pink Sheet Off-Label Guidance Creates ‘Safe Harbor’ For Dissemination of Certain Info To HCPs: https://pink.citeline.com/PS149058/Off-Label-Guidance-Creates-Safe-Harbor-For-Dissemination-of-Certain-Info-To-HCPsUnderwater: Medicare Negotiated Prices For Part B Cancer Drugs Could Change Prescribing: https://pink.citeline.com/PS149065/Underwater-Medicare-Negotiated-Prices-For-Part-B-Cancer-Drugs-Could-Change-PrescribingBertagnolli NIH Nomination Advances, But Sanders Will Remain Thorn In Side Of Biden’s Health Agenda: https://pink.citeline.com/PS149072/Bertagnolli-NIH-Nomination-Advances-But-Sanders-Will-Remain-Thorn-In-Side-Of-Bidens-Health-Agenda
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with behavioral health experts on implementing AI solutions to help ease the administrative burden on clinicians as well as recent coverage from the LSX Congress USA and HLTH conferences. Reed Miller discusses findings of EY’s annual pulse of the medtech industry report and Hannah Daniel discusses FDA guidance on regulating AI/ML.Medtech Insight articles addressing topics discussed in this episode:https://medtech.citeline.com/MT148350/EY-Report-Offers-Advice-For-Medtech-To-Regain-Its-Pre-COVID-Mojohttps://medtech.citeline.com/MT148349/Generative-AI-Providing-Behavioral-Health-Solutions-But-Not-Therapy--Yethttps://medtech.citeline.com/MT148349/Generative-AI-Providing-Behavioral-Health-Solutions-But-Not-Therapy--Yet
Over The Counter 24 Oct 2023: An Approach To MoCRA With Good Face Project’s Iva Teixeira by Citeline
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Daiichi’s huge ADC deal with Merck; mixed data for Rybrevant at ESMO; Pfizer girds for cost cuts; myeloma helps J&J’s Q3; and five key points for cell and gene Meeting on the Mesa.https://scrip.citeline.com/SC149230/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss BrainStorm’s next steps after withdrawing the NurOwn BLA (:38), NIH director nominee Monica Bertagnolli’s thoughts on drug affordability (8:13), and the US FDA’s effort to ensure long-term follow-up of gene therapy patients (19:41).More On These Topics From The Pink SheetBrainStorm Eyes New Phase III Trial For NurOwn In Mild ALS Following BLA Withdrawal: https://pink.citeline.com/PS149035/BrainStorm-Eyes-New-Phase-III-Trial-For-NurOwn-In-Mild-ALS-Following-BLA-WithdrawalNIH Nominee Says Americans Deserve ‘Return On Investment’ Via Affordable Meds, But Offers No Implementation Plan: https://pink.citeline.com/PS149040/NIH-Nominee-Says-Americans-Deserve-Return-On-Investment-Via-Affordable-Meds-But-Offers-No-Implementation-PlanObesity Funding, AI and Clinical Trial Diversity: Where The NIH Director Nominee Stands: https://pink.citeline.com/PS149046/Obesity-Funding-AI-and-Clinical-Trial-Diversity-Where-The-NIH-Director-Nominee-StandsUS FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies: https://pink.citeline.com/PS149041/US-FDA-Struggling-With-Long-Term-Follow-Up-Requirements-For-Gene-Therapies
n this special podcast, Medtech Insight managing editor Elizabeth Orr talks to consultant Steve Silverman about the FDA’s current position on real-world evidence and real-world data, as well as how manufacturers can best put the evidence types to use.
Q&A with Dr. Marc Sandberg: A Specialist in Endocrinology, Diabetes & Metabolism by Citeline
Listen as executives from Centrient Pharmaceuticals share insider perspectives on innovations in sustainable, efficient, clean manufacturing practices.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: BMS buys Mirati; slow Q3 for biopharma M&A; Roche on its neuroscience strategy; Alexion talks about AstraZeneca integration; and Gilead on trial diversity.https://scrip.citeline.com/SC149190/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown (:38), take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro (10:25), and incentives that the FDA could offer for ARPA-H projects that reach the application stage (20:16).More On These Topics From The Pink SheetShutdown Threat Forced US FDA To Cancel Some Travel: https://pink.citeline.com/PS149003/Shutdown-Threat-Forced-US-FDA-To-Cancel-Some-TravelAlnylam’s Complete Response Is Classic Example Of FDA-Advisory Committee Disagreement: https://pink.citeline.com/PS149000/Alnylams-Complete-Response-Is-Classic-Example-Of-FDA-Advisory-Committee-DisagreementUS FDA Rejects Onpattro Label Expansion: History Repeats In Reverse?: https://pink.citeline.com/PS149004/US-FDA-Rejects-Onpattro-Label-Expansion-History-Repeats-In-ReverseARPA-H, US FDA Discuss Incentives For Game-Changing Health Projects: https://pink.citeline.com/PS148944/ARPAH-US-FDA-Discuss-Incentives-For-GameChanging-Health-Projects
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Lilly’s radiopharmaceutical buy; strong third quarter for biotech financing; Novartis’s nephropathy results; US ICER runs cost analysis on first batch of drugs; and the outlook for US FTC oversight of biopharma M&A.https://scrip.citeline.com/SC149170/Quick-Listen-Scrips-Five-MustKnow-Things
릴리, 다케다, 아스트라제네카에 이어 MSD, 아스텔라스도 아일랜드에 대규모 투자 동참https://scrip.citeline.com/SC149047/Pharma-Cash-Keeps-Flowing-Into-Ireland
In this episode, HBW Insight speaks to its own OTC expert, managing editor Malcom Spicer, about recent controversy in the US surrounding oral nasal decongestant active ingredient phenylephrine. Used widely and safely by US consumers for around a half century, the efficacy of oral phenylephrine has come under question following a 2015 citizen petition by University of Florida pharmaceutical researchers, which asked the FDA to remove the ingredient from the final OTC CCABA monograph. Only recently addressing this petition, prompted Spicer points out by reforms to the US OTC monograph system, an FDA advisory panel has unanimously voted that research the FDA presented during a two-day meeting in September didn’t support oral phenylephrine’s efficacy for nasal decongestion at the CCABA monograph dose of 10mg. Drawing on his extensive experience and writing on this topic, Spicer takes us beyond the headlines to the key points you need to know about this crucial development, which may or may not have wider implications beyond the US.
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: major Q4 catalysts; Verona’s COPD contender; Alfasigma acquires Intercept; more setbacks for Keytruda/Lenvima combo; and new pressures on China IPOs.https://scrip.citeline.com/SC149131/Quick-Listen-Scrips-Five-MustKnow-Things
Scrip writers Joseph Haas and Jessica Merrill discuss US FTC overview of biopharma mergers like Amgen/Horizon and Pfizer/Seagen with Leerink Partners' analyst Dan Lepanto and ZS Associates partner Cody Powers.
Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug (:43), the impact of a government shutdown on the agency (10:00), and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations (22:58).More On These Topics From The Pink SheetBrainStorm’s NurOwn Gets Many, Many Thumbs Down From US FDA Panel: https://pink.citeline.com/PS148915/BrainStorms-NurOwn-Gets-Many-Many-Thumbs-Down-From-US-FDA-PanelPreparing For A Shutdown: US FDA To Retain 81% Of Workforce, Thanks Mostly To User Fees: https://pink.citeline.com/PS148923/Preparing-For-A-Shutdown-US-FDA-To-Retain-81-Of-Workforce-Thanks-Mostly-To-User-FeesRepublican Lawmaker Takes Unusual Step Of Attacking FDA Salaries Over Abortion Pill Decisions: https://pink.citeline.com/PS148917/Republican-Lawmaker-Takes-Unusual-Step-Of-Attacking-FDA-Salaries-Over-Abortion-Pill-Decisions Imbruvica, Enbrel, Stelara Offer Best Chance Of Savings From Medicare Negotiation In First Round: https://pink.citeline.com/PS148916/Imbruvica-Enbrel-Stelara-Offer-Best-Chance-Of-Savings-From-Medicare-Negotiation-In-First-Round
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Novartis gives back Beigene PD-1; BMS revs R&D engine; Anthos changes course for Factor XI asset; the non-incretin pipeline for obesity; and a look at Q2’s top-selling drugs.https://scrip.citeline.com/SC149111/Quick-Listen-Scrips-Five-MustKnow-Things
In this episode, HBW Insight catches up with UK switch specialists Maxwellia to find out what’s next for the company that gave to the UK one of the first OTC daily contraceptive pills. Now a disruptive consumer health player in its own right, the company is looking for investors to take it to the next level and help launch two new women’s health products in the pipeline for next year, CEO Anna Maxwell reveals in this exclusive interview.
Industry veteran and serial entrepreneur Daphne Koller tells In Vivo about how her company, Insitro, is unleashing the potential of computational biology and machine learning to discover new drug compounds.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Biomarin’s next chapter; Amgen’s obesity plans; Daiichi’s new ADC data; Acelyrin hit by clinical failure; and Skyrizi beats Stelara in Crohn’s.https://scrip.citeline.com/SC149072/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporter and editors discuss the somewhat novel pricing language in Regeneron’s deal with the US government to develop a COVID-19 monoclonal antibody (:34), US FDA Commissioner Robert Califf hiring a new senior advisor (12:10), and optimizing dosing in cancer combination therapies (21:21).More On These Topics From The Pink SheetPrice Caps In Regeneron’s COVID Monoclonal Deal With HHS: Not A Precedent, But Enough For Bernie: https://pink.citeline.com/PS148843/Price-Caps-In-Regenerons-COVID-Monoclonal-Deal-With-HHS-Not-A-Precedent-But-Enough-For-BernieCaliff Hires New US FDA Senior Advisor, But Duties Seem Vague: https://pink.citeline.com/PS148848/Califf-Hires-New-US-FDA-Senior-Advisor-But-Duties-Seem-VagueProject Optimus Is Coming To Cancer Combination Therapy Development: https://pink.citeline.com/PS148841/Project-Optimus-Is-Coming-To-Cancer-Combination-Therapy-Development
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: the rise of Novo Nordisk; senior level changes at Novartis; Moderna’s progress against BA.2.86; major new CNS drugs coming; and Boehringer Ingelheim’s head of innovation on R&D priorities. https://scrip.citeline.com/SC149038/Quick-Listen-Scrips-Five-MustKnow-Things
In the second part of HBW Insight’s exclusive interview with OTC industry veteran Birgit Schuhbauer, we discuss the trends that will shape the future of consumer health. Drawing on her extensive experience in consumer health, most recently as global vice president of J&J’s Self Care franchise and president of the AESGP,Schuhbauer gives her views on: consumer shifts towards self-care and prevention, digitalisation and e-commerce, supply chain resilience and sustainability. Schuhbauer also gives an insider perspective on moves by companies like Kenvue and Haleon to spin out as independent OTC players, and the implications for Rx-to-OTC switch, for example.
어동규 대웅이노베이션홀딩스 대표의 Scrip Intelligence 인터뷰 기사를 요약한 내용입니다https://scrip.citeline.com/SC148741/Know-The-Enemy-And-Know-Yourself-Before-Entering-US-Daewoong-Exec-Advises
Pink Sheet reporter and editors discuss the US Federal Trade Commission ending its attempt to block the Amgen acquisition of Horizon Therapeutics (:28), a proposed public-private partnership to develop ultra-rare cancer drugs (9:54), and a slow-down in ANDA submissions to the US Food and Drug Administration (22:02).More On These Topics From The Pink SheetFTC’s Test Case Opposing Amgen-Horizon Deal Ends With No-Bundling Agreement: https://pink.citeline.com/PS148804/FTCs-Test-Case-Opposing-Amgen-Horizon-Deal-Ends-With-No-Bundling-AgreementUltra-Rare Tumors: Public-Private Partnership Eyed To Boost Drug Development: https://pink.citeline.com/PS148813/Ultra-Rare-Tumors-Public-Private-Partnership-Eyed-To-Boost-Drug-DevelopmentANDA Submissions Lagging As FY 2023 Nears Its End: https://pink.citeline.com/PS148818/ANDA-Submissions-Lagging-As-FY-2023-Nears-Its-End
In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. We talk to Marcel about global regulations for Cyted’s product Endosign, and how his company chose to leverage the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.
In this latest instalment of the In Vivo podcast Daniel Lofaso, CEO of Digital Elevator, talks about the common mistakes biotech companies make when trying to build their brand, how to connect with varied audiences and key trends the industry should keep track of in digital marketing.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: US Medicare price negotiations get soft landing; Medicare negotiations and patent cliff acceleration; Novo Nordisk steps into heart failure; PCSK9s and the convenience battle; and an investor’s view of Korean biotech potential.https://scrip.pharmaintelligence.informa.com/SC148990/Quick-Listen-Scrips-Five-MustKnow-Things
Summary:In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.Medtech Insight articles addressing topics discussed in this episode:GaitBetter On Mission To Bring VR, AI-Based Solution To Gait Training; Will Physical Therapists Pay For It?ReWalk Robotics’ Planned Acquisition Of Anti-Gravity Maker AlterG For $19M Paves Way To ProfitabilityNIST Cybersecurity Framework 2.0 Expands Guidance’s Scope, Introduces ‘Govern’ FunctionVulnerabilities Up 59%: The State Of Healthcare Cybersecurity In 2023Cybersecurity Expert Says eSTAR Requirement Will Push FDA, Industry In Positive Direction
Pink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released (:34) and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process (22:44).
More On The Medicare Price Negotiation List From The Pink Sheet
Litigation Against Medicare Price Negotiation Gains Four Potential New Plaintiffs: https://pink.pharmaintelligence.informa.com/PS148778/Litigation-Against-Medicare-Price-Negotiation-Gains-Four-Potential-New-Plaintiffs
Medicare Negotiation List Surprises Highlight The Importance Of Current Spending Data: https://pink.pharmaintelligence.informa.com/PS148781/Medicare-Negotiation-List-Surprises-Highlight-The-Importance-Of-Current-Spending-Data
Patent Cliff Likely Accelerated By Two Years For Most Drugs On Medicare Price Negotiation List: https://pink.pharmaintelligence.informa.com/PS148775/Patent-Cliff-Likely-Accelerated-By-Two-Years-For-Most-Drugs-On-Medicare-Price-Negotiation-List
Price Negotiation Purgatory: Upcoming Biosimilars Couldn’t Keep Stelara, NovoLog Off The List: https://pink.pharmaintelligence.informa.com/PS148776/Price-Negotiation-Purgatory-Upcoming-Biosimilars-Couldnt-Keep-Stelara-NovoLog-Off-The-List
Timetable For Medicare Price Negotiation Of The First 10 Drugs (And Beyond): https://pink.pharmaintelligence.informa.com/PS148760/Timetable-For-Medicare-Price-Negotiation-Of-The-First-10-Drugs-And-Beyond
CMS Seeking Patient Comments On Negotiated Drugs Similar To US FDA’s PFDD Program: https://pink.pharmaintelligence.informa.com/PS148773/CMS-Seeking-Patient-Comments-On-Negotiated-Drugs-Similar-To-US-FDAs-PFDD-Program
Big Rebates Already A Big Factor For Drugs On Medicare Negotiation List: https://pink.pharmaintelligence.informa.com/PS148774/Big-Rebates-Already-A-Big-Factor-For-Drugs-On-Medicare-Negotiation-List
Price Negotiation And The GLP1 Class: Trulicity Lucky To Be A BLA: https://pink.pharmaintelligence.informa.com/PS148794/Price-Negotiation-And-The-GLP1-Class-Trulicity-Lucky-To-Be-A-BLA
More On The Pepaxto Withdrawal From The Pink Sheet
To Save Pepaxto, Oncopeptides Throws Shade At IMiD Use In Elderly Myeloma Patients: https://pink.pharmaintelligence.informa.com/PS148770/To-Save-Pepaxto-Oncopeptides-Throws-Shade-At-IMiD-Use-In-Elderly-Myeloma-Patients
How Fast Is ‘Expedited’? Pepaxto To Show Speed Of New Withdrawal Process For Accelerated Approval Drugs: https://pink.pharmaintelligence.informa.com/PS148766/How-Fast-Is-Expedited-Pepaxto-To-Show-Speed-Of-New-Withdrawal-Process-For-Accelerated-Approval-Drugs
FDA’s Pepaxto Decider: Peter Marks To Handle Oncopeptides’ Appeal Of Accelerated Approval Withdrawal: https://pink.pharmaintelligence.informa.com/PS148761/FDAs-Pepaxto-Decider-Peter-Marks-To-Handle-Oncopeptides-Appeal-Of-Accelerated-Approval-Withdrawal
Hua Medicine’s founder and CEO Li Chen discusses with host Brian Yang about its new product launch for dorzagliatin, glucokinase activator for type 2 diabetes in China, partnership with Bayer, and plans to get reimbursed through National Reimbursement Drug List.
Scrip’s senior editor Vibha Ravi speaks with Dr Thomas Rademacher, Emergex CEO and ex-research director at the University of Oxford, about the myth of the “Wuhan virus” and why synthetic T-cell adaptive vaccines are expected to be superior to RNA/mRNA ones. Novel delivery mechanisms like patches and microneedles are part of the UK-based clinical-stage biotech’s plan to make universal coronavirus and influenza vaccines affordable and effective as it seeks to partner governments
Listen in as experts from Advanced Clinical discuss the evolution of the decentralized clinical trial model and what it means in a post-COVID landscape. Experts from Advanced Clinical share their thoughts on the benefits, challenges, management considerations, and outlook for such trials in this short podcast, packed with operational insights.
In this episode, HBW Insight talks to BSS Consulting’s Birgit Schuhbauer about her stellar career in consumer healthcare. Up until recently, Schuhbauer was global vice president for Johnson & Johnson’s Self Care Franchise and president of the Association of the European Self-Care Industry. Now setting up on her own, Schuhbauer reflects on her career highlights, what it takes to be a leader in OTC and on her role as the AESGP’s first female president during a time of unprecedented change.
Mithra is shaking up the stagnant women’s health market with a brand new estrogenic compound. E4, or estetrol, is a natural estrogen produced by the human fetus during pregnancy, and could represent a major breakthrough in contraceptive and menopause care.
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Roche’s TIGIT data leak; Regeneron gets important US approvals; COVID subvariant vaccine progress; Pfizer’s RSV vaccine extended approval; and Japan recommends lecanemab for Alzheimer’s. https://scrip.pharmaintelligence.informa.com/SC148952/Quick-Listen-Scrips-Five-MustKnow-Things
In this Chinese-language podcast, Brian Yang and Dexter Yan discuss the latest hot topics in August in China’s biotech sector, which include a massive anti-corruption campaign and PD-1 inhibitor antibody development and approval prospects in the US.
https://scrip.pharmaintelligence.informa.com/SC148929/ChineseLanguage-Podcast-AntiCorruption-Campaign-PD1-Going-Global
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: a look at global executive compensation; Pfizer’s new myeloma approval; Merck and Sichuan trump ADC breast cancer success; combo Alzheimer’s therapies in Eisai’s pipeline; and an overview of the state of gene therapy. https://scrip.pharmaintelligence.informa.com/SC148914/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss a projected list of drugs that could be eligible for the first round of Medicare price negotiations (:40), the future of mifepristone access after the latest court decision (9:24), and AstraZeneca receiving the first US FDA drug promotion warning letter in more than a year (21:55).
More On These Topics From The Pink Sheet
Medicare Price Negotiation List Remains A Puzzle, Even For Those That Are (Probably) On It: https://pink.pharmaintelligence.informa.com/PS148718/Medicare-Price-Negotiation-List-Remains-A-Puzzle-Even-For-Those-That-Are-Probably-On-It
Mifepristone REMS Modifications Likely Violated Administrative Procedure Act, Appeals Court Says: https://pink.pharmaintelligence.informa.com/PS148721/Mifepristone-REMS-Modifications-Likely-Violated-Administrative-Procedure-Act-Appeals-Court-Says
Breaking Down The Arguments In The Mifepristone Case: https://pink.pharmaintelligence.informa.com/PS148678/Breaking-Down-The-Arguments-In-The-Mifepristone-Case
The Mifepristone Story So Far: Tracing The Origins Of The Legal Fight Over The Abortion Pill: https://pink.pharmaintelligence.informa.com/PS148679/The-Mifepristone-Story-So-Far-Tracing-The-Origins-Of-The-Legal-Fight-Over-The-Abortion-Pill
AstraZeneca Gets Rare Warning Letter Over Breztri Sales Aid; Footnotes Don’t Balance Graphics: https://pink.pharmaintelligence.informa.com/PS148710/AstraZeneca-Gets-Rare-Warning-Letter-Over-Breztri-Sales-Aid-Footnotes-Dont-Balance-Graphics
Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Wegovy’s solid new trial results; Lilly’s sales swing back; nothing off the table for new Bayer boss; new compliance crackdown in China; and McKinsey on AI.
Pink Sheet reporters and editors discuss the impact of a study showing cardiovascular benefits for the weight loss drug Wegovy (:45), another attempt to restrict mifepristone access (16:15), and a new threat to the US FDA’s hybrid work policy (26:35).
More On These Topics From The Pink Sheet
Wegovy’s Cardiovascular Benefits May Improve, But Not Transform, Insurance Coverage In Obesity:
https://pink.pharmaintelligence.informa.com/PS148672/Wegovys-Cardiovascular-Benefits-May-Improve-But-Not-Transform-Insurance-Coverage-In-Obesity
Obesity Advocates Meet With FDA Commissioner, Push On Difference vs. Short-Term Weight-Loss:
https://pink.pharmaintelligence.informa.com/PS148673/Obesity-Advocates-Meet-With-FDA-Commissioner-Push-On-Difference-vs-ShortTerm-WeightLoss
New Attack Against FDA’s Mifepristone Approval Targets Potential Water Contamination:
https://pink.pharmaintelligence.informa.com/PS148671/New-Attack-Against-FDAs-Mifepristone-Approval-Targets-Potential-Water-Contamination
Peter Marks’ Fears May Come True: White House Wants More In-Person Work:
https://pink.pharmaintelligence.informa.com/PS148674/Peter-Marks-Fears-May-Come-True-White-House-Wants-More-In-Person-Work
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。
今回取り上げた記事はこちら
「 Tracking Industry’s Lawsuits Against IRA’s Medicare Price Negotiations（邦題意訳：アメリカ反インフレ法 薬価をめぐる法廷闘争の現在地）」
https://scrip.pharmaintelligence.informa.com/SC148794/Tracking-Industrys-Lawsuits-Against-IRAs-Medicare-Price-Negotiations
In the second part of HBW Insight’s chat with Bristows digital health regulatory expert Jamie Hatzel, we talk about artificial intelligence. Specifically, we discuss what happens to Software as a Medical Device within incoming EU artificial intelligence legislation, which has now entered trilogue negotiations. Issues such as the meaning of “high risk” within the proposed AI Act, in contrast to its meaning in the existing Medical Device Regulations, highlight the importance for manufacturers in this space or thinking about entering it of getting good advice, Hatzel points out.
Citeline의 최신 연구보고서에 따르면 미국시장에서 대형 일본제약사들의 항암제, CNS 치료제 허가가능성이 상대적으로 높은 것으로 나타났다. 어떤 요인이 작용했을까? (Scrip 기사를 요약한 내용입니다)
https://scrip.pharmaintelligence.informa.com/SC148677/Whats-Behind-Japan-Firms-Higher-Approval-Rates-In-Challenging-Oncology-CNS-Areas
In this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations, so if you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.
Audio roundup of selected biopharma industry content from Scrip over the past business week. Links to discussed stories at the link below:
https://scrip.pharmaintelligence.informa.com/SC148789/Quick-Listen-Scrips-Five-MustKnow-Things
Scrip’s Mumbai-based senior editor Vibha Ravi speaks with Dr B N Manohar, CEO of Indian cell and gene therapy firm Stempeutics Research. The company counts Cipla as an investor and has partnered with both Cipla and Alkem Labs for the marketing of cell therapy Stempeucel. This became the first patented cell therapy platform to be approved for commercial use in India, for knee osteoarthritis and critical limb ischemia. Manohar talks about these and other topics including plans and strategy.
Brian Yang, Dexter Yan and guest Jin Wang discuss trending biotech topics including recent antibody deals, China biotech innovation and underlying drivers as well as the outlook for the sector, in this Chinese-language podcast. Other topics include BioNTech’s recent China R&D collaborations and COVID-19 vaccine developments.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb looks back at ADA 2023 highlights and her interviews with diabetes company execs. Reed Miller discusses his Cardio Conversation with Volta Medical and Hannah Daniel discusses the FDA’s Clinical Decision Support Software final guidance.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Diabetes, ADA 2023
Better Therapeutics Plans Diabetes PDT Launch Following FDA De Novo Authorization
Exec Chat: Tandem CEO Sheridan On Coming Mobi Pump, New Algorithms, And Taking Share From Medtronic
‘Closest To What The Pancreas Would Actually Do’: Medtronic Diabetes Execs On Marketing Plans for MiniMed 780G
Exec Chat: Dexcom’s CEO On Meeting New CGM Markets While Scoping Consumer Opportunities
AI, Regulatory Watch
Cardio Conversations: 'Trials, Trials, Trials!' Volta Has Big Ambitions For AI In EP
What Changes To The AI Act Would Benefit Medtech Most?
CDS Final Guidance Infringes On Free Speech, Professor Says
9xchange CEO Anat Naschitz and Benevolent AI's Matthew Fujisawa spoke with In Vivo about how they are trying to make selling and buying pharma assets more efficient through a digital marketplace and AI.
Digitalisation is a hot topic in consumer health, and “digital health” covers a broad spectrum of applications, from wellness apps to virtual reality therapeutics. In this episode, HBW Insight speaks to regulatory expert Jamie Hatzel to get some clarity on “software as a medical device” – a subset of medical device regulatory frameworks within which many digital health applications are classified. In the first part of a two-part podcast, Hatzel briefly outlines the UK and EU regulatory approaches to SaMDs, before we discuss specific examples such as symptom trackers, wellness apps and digital therapeutics. In the second part, we talk about artificial intelligence, how incoming AI regulations impact SaMDs and whether OTC firms should take the plunge into this highly regulated but nevertheless very exciting space.
Explore best practices for gathering, preparing, and managing data for clinical Phase I clinical trials from start to finish.
Learn about the cost- and time-saving benefits of basing early phase and first in human clinical trials in Canada.
Listen in as experts discuss the advantages of an integrated approach supporting drug development from discovery to commercialization.
Explore the latest trends in biotech funding, the strategies for successful alignment with investment priorities, and the supportive role of CROs in the process.
Discover the key challenges facing clinical trial delivery and the current trends and solutions required to optimize efficiency and enhance results.
In Vivo executive editor Lucie Ellis-Taitt and Infex CEO Peter Jackson explore the current state of antimicrobial resistance in the UK, and worldwide. They discuss the potential of a new “Netflix” style subscription model in the UK for antibiotic reimbursement, as well as future challenges for biotechs in the anti-infectives space.
Audio roundup of selected biopharma industry content from Scrip over the past business week.
Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC148715/Quick-Listen-Scrips-Five-MustKnow-Things
Dr. Avni Finn, retina specialist affiliated with Vanderbilt Eye Institute shares her experiences with new modalities and ways to optimize/personalize nAMD treatment in both Treatment Naïve and Switch patients.
Click here to listen to the podcast.
BSI's Graeme Tunbridge, Qserve's Gert Bos and TUV SUD's Andreas Stange talk with Medtech Insight's Amanda Maxwell about how the recent amending regulation to the EU's Medical Device Regulation has changed the EU medtech regulatory landscape.
Dr. Matthew Galsky, Director of GU Medical Oncology, The Tisch Cancer Institute, Mount Sinai, New York discusses clinical trial data and RWE in assessing treatment options for patients with high-risk urothelial carcinoma.
Click here to watch Dr. Galsky discuss recurrence rates, clinical trial data, and RWE when assessing treatment options for patients with high-risk urothelial carcinoma.
Audio roundup of selected content from Scrip over the past business week.
Quick Listen: Scrip's Five Must-Know Things: https://scrip.pharmaintelligence.informa.com/SC148667/Quick-Listen-Scrips-Five-MustKnow-Things
In this edition of Cardio Conversations, Medtech Insight talked to Théophile Mohr Durdez, the CEO and co-founder of Volta Medical, a Marseille based company applying artificial intelligence to electrophysiology. Volta has raised over €70m and is sponsoring TAILORED-AF to evaluate its atrial fibrillation ablation guided by its VXI decision-support software.
More on AI and electrophysiology from Medtech Insight:
https://medtech.pharmaintelligence.informa.com/MT147825/Cardio-Conversations-Vektor-Addresses-Global-Health-Crisis-With-Arrythmia-Mapping
https://medtech.pharmaintelligence.informa.com/MT147560/Cardio-Conversations-Steven-Mickelsen-Discusses-PFA-Electrophysiology-And-What-It-Takes-To-Be-A-Physician-Inventor
https://medtech.pharmaintelligence.informa.com/MT145760/Cardio-CatchUp-Arga-HeartPoint-Plan-FirstInHuman-Trials-Of-Novel-Devices-Medtronic-And-Edwards-Announce-Product-Launches-And-More
https://medtech.pharmaintelligence.informa.com/MT145539/Cardio-CatchUp-Updates-From-BSecur-egnite-Vektor-And-Other-UnderTheRadar-Companies
https://medtech.pharmaintelligence.informa.com/MT122844/New-AI-Tech-To-Improve-AFib-Treatment-Slated-For-2020-Market-Launch
Two leading notified body experts, BSI’s Graeme Tunbridge, and TÜV SÜD’s Andreas Stange, in addition to consultant Gert Bos, once head of BSI notified body medtech services, joined Medtech Insight’s Amanda Maxwell to examine what impact the IVDR amending regulation, published some 18 months ago, has had on manufacturer applications to notified bodies. They revealed that the hyper around backlogs at notified bodies is exaggerated and not an excuse for inaction. The content of this podcast is reflected in this article and one due to be published in Medtech Insight on 6 July.
In this episode, Medtech Insight spoke to three decentralized clinical trial experts at Hogan Lovells: partner Kristin Zielinski Duggan, partner Blake Wilson and associate Stephanie Agu. We discussed the ins and outs of the draft, what pieces of the guidance still might need clarification, and how they expect to see the industry change as DCTS become mainstream.
Audio roundup of selected content from Scrip over the past business week. https://scrip.pharmaintelligence.informa.com/SC148645/Quick-Listen-Scrips-Five-MustKnow-Things
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb and Hannah Daniel discuss highlights from their DTA Summit coverage in Washington. Reed Miller talked to Frank Chan, the president of Medtronic’s Patient Monitoring, about plans for the patient monitoring as an independent company and Bayer AG’s new business unit focusing on digital health. Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Digital Therapeutics Alliance Summit
DTA Panel Discusses Future Of Digital Therapeutics, Obstacles To Wider Adoption
The Afterlife Of Pear Therapeutics: Korean DTx Maker Discusses Vision For Salvaged Migraine Assets
The Frontier Of Digital Therapeutics Regulations
Pear Bankruptcy Filing Highlights Difficult Challenges Facing Digital Therapeutics
Exec Chat: Medtronic’s Chan Discusses Future Of Connected Care In A Stressed System
Minute Insight: Bayer Launches Precision Health Unit To Focus On Digital Consumer Health
Audio roundup of selected content from Scrip over the past business week.
Quick Listen: Scrip's Five Must-Know Things: https://scrip.pharmaintelligence.informa.com/SC148608/Quick-Listen-Scrips-Five-MustKnow-Things?utm_source=sfmc&utm_medium=email&utm_campaign=Scrip%20Weekly%20Email
In this episode, HBW Insight looks at yet another piece of EU sustainability legislation, this time the Green Claims Code. Sustainability expert Jo Stephenson, managing director of PHD Marketing, explains the background to the legislation, which proposes detailed rules for companies that wish to make environmental claims. Although companies are not required to make green claims, and may choose not to given these stricter rules, Stephenson points out that companies will soon be required to record and report extensive environmental data in the future, so may as well use this information to create robust and credible green claims in future. Being used to strict rules on making health claims, consumer healthcare firms are in a good position to embrace and even benefit from this new framework, Stephenson also points out.
Experts weigh-in on AI-driven imaging’s potential to transform oncology clinical trials, leading to better outcomes for patients and sponsors.
Other platforms:
Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836
Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz
TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/
Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Listen to our podcast for tips on entering this year's Global Generics & Biosimilars Awards
Audio roundup of selected content from Scrip over the past business week.
Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC148580/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors consider the upcoming COVID-19 vaccination campaign (:37), the virtue of advisory committees with only a few members (19:42), and the first FDA drug advertising untitled letter in a year (25:08). Read More In The Pink Sheet
COVID Vaccines: XBB Strain Easy Call, But Disagreements Abound Between FDA, Advisors On Logistics https://pink.pharmaintelligence.informa.com/PS148385/COVID-Vaccines-XBB-Strain-Easy-Call-But-Disagreements-Abound-Between-FDA-Advisors-On-Logistics
Are US FDA Advisory Committees Too Big? Lecanemab Shows Benefit Of Thinking Small https://pink.pharmaintelligence.informa.com/PS148382/Are-US-FDA-Advisory-Committees-Too-Big-Lecanemab-Shows-Benefit-Of-Thinking-Small
With First Advertising Letter In 12 Months, US FDA Goes After Xeris’s Webpage Promotion Of Recorlev https://pink.pharmaintelligence.informa.com/PS148371/With-First-Advertising-Letter-In-12-Months-US-FDA-Goes-After-Xeriss-Webpage-Promotion-Of-Recorlev
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。
今回取り上げた記事はこちら：「US FDA Complete Response Letter Rates Vary With Sponsor Size（邦題意訳：「大企業ほど承認申請に強い」説、過去2年分のデータで証明される）」
https://pink.pharmaintelligence.informa.com/PS148291/US-FDA-Complete-Response-Letter-Rates-Vary-With-Sponsor-Size
「US FDA’s Review Landscape」
https://infogram.com/1p2jr9d6k7y9wwf0n01yyqn6peirmzd65me
Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC148538/Quick-Listen-Scrips-Five-MustKnow-Things
Guest speaker Leon Tang Brian Yang in Beijing and Dexter Yan in Shanghai to discuss what stands out in this special episode devoted to ASCO of the latest Chinese-language podcast.
Over The Counter 9 June 2023: Embracing AI/AR Evolution In Beauty, While Navigating Its Hurdles by Pharma Intelligence
In this episode, MedTech Insight regulatory reporter speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations and Erez shares a personal story about why the safety of medical devices matters so much to him.
점점 더 많은 미국과 아시아계 제약바이오 기업들이 스위스에 EU 본부를 설립하고 있는 배경에 대한 Scrip 기사를 요약한 내용입니다.https://scrip.pharmaintelligence.informa.com/SC148478/From-Hengrui-To-Moderna-Why-More-Biotech-Companies-Are-Creating-Swiss-Hubs
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC148490/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss CMS’s latest coverage announcement for Alzheimer’s drugs and the VA’s approach to the issue (0:29), the FDA’s new one-page patient medication information document (15:55), international convergence on COVID-19 vaccine strain selection (24:48), and Novavax’s place in the vaccine toolbox going forward (28:21).Read More In The Pink SheetMedicare Registry Plan For Alzheimer’s Drugs Pairs CMS Web Portal With Health System Effortshttps://pink.pharmaintelligence.informa.com/PS148313/Medicare-Registry-Plan-For-Alzheimers-Drugs-Pairs-CMS-Web-Portal-With-Health-System-Efforts The US VA And Alzheimer’s: A Misunderstood Decisionhttps://pink.pharmaintelligence.informa.com/PS148214/The-US-VA-And-Alzheimers-A-Misunderstood-DecisionOne-Page Patient Medication Information Document Moves Forward Under Proposed Rulehttps://pink.pharmaintelligence.informa.com/PS148298/One-Page-Patient-Medication-Information-Document-Moves-Forward-Under-Proposed-Rule International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccinehttps://pink.pharmaintelligence.informa.com/PS148301/International-Regulators-Focus-On-Omicron-XBB-For-Monovalent-COVID-19-Vaccine Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availabilityhttps://pink.pharmaintelligence.informa.com/PS148261/Novavax-Readying-Multiple-COVID-19-Vaccine-Candidates-To-Ensure-Fall-Availability
NSCLC Disease Analysis Reporthttps://service.datamonitorhealthcare.com/hkc/disease/oncology/lung-cancer/non-small-cell-lung-cancer/disease-analysis/article218222.eceNSCLC Forecasthttps://service.datamonitorhealthcare.com/hkc/disease/oncology/lung-cancer/non-small-cell-lung-cancer/forecast/article141043.eceHER2+ Breast Cancer Disease Analysis Reporthttps://service.datamonitorhealthcare.com/hkc/disease/oncology/gynecological-cancer/breast-cancer-her2-positive/disease-analysis/article213383.eceHER2+ Breast Cancer Forecasthttps://service.datamonitorhealthcare.com/hkc/disease/oncology/gynecological-cancer/breast-cancer-her2-positive/forecast/article108428.eceOther platformsApple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Regulatory strategists present key publishing strategies to consider when planning your marketing application for successful regulatory outcomes. Don’t miss insights into creating your strongest marketing application strategy, with guidelines from experts at Veristat. You’ll learn more about the important steps to follow for:•Building a publishing-specific team and educating stakeholders about the document submission process•Creating an effective communication strategy•Mitigating delays•Understanding timelines •And much more
Successfully navigate the complexities of the Chemical, Manufacturing, and Controls (CMC) portions of Investigational New Drug (IND) applications. Listen in as experts provide their insider perspectives on common CMC- and IND- related questions.
Listen to expert perspectives on the recent history of DEI in clinical trials and the barriers to patient participation. Listen now to a lively and informative discussion that addresses the questions: •What has changed in patient recruitment strategies from pre- to post-COVID and why?•What factors influenced a new focus on DEI during the time of COVID?•What are the barriers to DEI for patient recruitment in Phase I and Phase II studies?•And more
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC148456/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss the largest pharma companies’ pending applications (0:41), the FDA delaying its decision on Sarepta’s gene therapy in Duchenne muscular dystrophy (14:32), and a plan to add more temporary members to agency advisory committees (24:55) … as well as a little bit of “The Simpsons.”Read More In The Pink SheetEverything’s Coming Up Pfizer: The Biggest Of Pharma Firms Leads Industry In Pending Applications For US FDA Approval https://pink.pharmaintelligence.informa.com/PS148271/Everythings-Coming-Up-Pfizer-The-Biggest-Of-Pharma-Firms-Leads-Industry-In-Pending-Applications-For-US-FDA-Approval Big Pharma At US FDA: A Regulatory Scorecardhttps://pink.pharmaintelligence.informa.com/PS148265/Big-Pharma-At-US-FDA-A-Regulatory-Scorecard Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Lettershttps://pink.pharmaintelligence.informa.com/PS148280/Lilly-Unlucky-Lilly-Leads-Big-Pharma-In-US-FDA-Complete-Response-Letters Everybody Stumbles: US FDA Complete Response Letters To Big Pharmahttps://pink.pharmaintelligence.informa.com/PS148279/Everybody-Stumbles-US-FDA-Complete-Response-Letters-To-Big-Pharma Sarepta’s DMD Gene Therapy: Approval Delayed And Indication Narrowed, But Still On Trackhttps://pink.pharmaintelligence.informa.com/PS148268/Sareptas-DMD-Gene-Therapy-Approval-Delayed-And-Indication-Narrowed-But-Still-On-Track Expect More Temporary Members Voting In US FDA Advisory Committeeshttps://pink.pharmaintelligence.informa.com/PS148243/Expect-More-Temporary-Members-Voting-In-US-FDA-Advisory-Committees
HBW Insight catches up with our own US Executive Editor, Malcolm Spicer, to find out all about Perrigo subsidiary HRA Pharma’s Rx-to-OTC switch of its daily contraceptive, Opill. Currently under consideration by the US Food and Drug Administration after a positive recommendation from its advisory committees, Spicer draws on 30+ years of writing about the US consumer healthcare market, as well as his extensive coverage of the subject, to tell us all we need to know about this historic switch.
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC148417/Quick-Listen-Scrips-Five-MustKnow-Things
Brian Yang and Dexter Yan discuss the latest China biotech trends and topics including recent mega-million deals between domestic biotechs and MNCs, the inaugural Asia Bio Partnering Forum and drug makers’ creative ways to financing amid lingering “capital winter”, and GLP-1 receptor agonists stepping into the spotlight and its potential to become the next hot pursuit after PD-1 in China.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses how two medtech CEOs are and aren’t using ChatGPT in their businesses while Reed Miller talks about his “Cardio Conversations” podcast interviews with Quentin Blackford, CEO of iRhythm and Rob Krummen, CEO of Vektor Medical. Washington, DC-based reporter Hannah Daniel reviews highlights from the HIMSS conference and the latest updates on FDA guidances.Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in this episode:Cardio Conversations: iRhythm Prepares To Deliver ‘Standard-Of-Care’ Cardiac MonitoringCardio Conversations: Vektor Addresses ‘Global Health Crisis’ With Arrythmia MappingHIMSS23Using The Metaverse To Break Down Language Barriers and Improve Diversity In Clinical TrialsTales From HIMSS23: FDA On FHIR And AI For The VoicelessDecentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of HealthcareExpert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’How Two Medtech CEOs Are (And Aren’t) Using ChatGPT In Their Businesses
Quick Listen: Scrip's Five Must-Know Things:https://scrip.pharmaintelligence.informa.com/SC148375/Quick-Listen-Scrips-Five-MustKnow-Things
Quentin Blackford, CEO of iRhythm, talked to Medtech Insight about his company’s plans to bring its Zio long-term cardiac monitoring platform to more patients by building its evidence base and marketing in more countries outside the US.For more information on iRhythm, cardiac monitoring and ECG technologies, check out these articles at Medtech Insight.Cardio Conversations: Vektor Addresses ‘Global Health Crisis’ With Arrythmia Mappinghttps://medtech.pharmaintelligence.informa.com/MT147825/Cardio-Conversations-Vektor-Addresses-Global-Health-Crisis-With-Arrythmia-MappingCMS Proposes National Payments For Long-Term Continuous Electrocardiogram Monitoringhttps://medtech.pharmaintelligence.informa.com/MT145597/CMS-Proposes-National-Payments-For-Long-Term-Continuous-Electrocardiogram-MonitoringFDA Clears iRhythm’s Afib-Detecting Wearable Running Software Co-Developed By Verilyhttps://medtech.pharmaintelligence.informa.com/MT145646/FDA-Clears-iRhythms-Afib-Detecting-Wearable-Running-Software-Co-Developed-By-VerilyExec Chat: As Reimbursement Questions Get Answers, iRhythm Looks To The Futurehttps://medtech.pharmaintelligence.informa.com/MT145401/Exec-Chat-As-Reimbursement-Questions-Get-Answers-iRhythm-Looks-To-The-FutureJPM 2022: Abbott, iRhythm, Novocure, Zimmer Biomethttps://medtech.pharmaintelligence.informa.com/MT144935/JPM-2022-Abbott-iRhythm-Novocure-Zimmer-BiometExec Chat: New iRhythm CEO Foresees Enormous Opportunity In AI For Arrhythmia Detectionhttps://medtech.pharmaintelligence.informa.com/MT144913/Exec-Chat-New-iRhythm-CEO-Foresees-Enormous-Opportunity-In-AI-For-Arrhythmia-DetectionDexcom COO Quentin Blackford Takes CEO Job At iRhythmhttps://medtech.pharmaintelligence.informa.com/MT144461/Dexcom-COO-Quentin-Blackford-Takes-CEO-Job-At-iRhythm
스크립의 박재홍 동아ST R&D 총괄 부문 사장 인터뷰 기사를 요약한 내용입니다https://scrip.pharmaintelligence.informa.com/SC148059/Dong-A-ST-Faces-New-Wave-Of-Change-As-It-Challenges-Norms
In this episode, HBW Insight speaks to the Global Self-Care Federation’s director of regulatory and scientific affairs, Padmaja Kamath, about the organisation’s sustainability work. In 2019, GSCF published its Global Charter for Environmental Sustainability, which represented, Kamath notes, the global consumer healthcare industry’s “first commitment to drive sustainable self-care.” Kamath updates us on the progress of the charter, which calls on GSCF members to pledge to make progress on one or more of three key sustainability areas: plastics and packaging, pharmaceuticals in the environment and CO2 footprint. We dive a little deeper into some specific challenges within these areas, such as recyclable blister packs and supply chain emissions, with Kamath pointing also to an upcoming GSCF webinar on the latter.
Quick Listen: Scrip's Five Must-Know Things:https://scrip.pharmaintelligence.informa.com/SC148335/Quick-Listen-Scrips-Five-MustKnow-Things
Scrip senior writer Joseph Haas overviews biopharma deal-making in 2022 and discusses the Pfizer/Seagen merger and what that may mean for pharma M&A during the remainder of 2023, with EF Hutton analyst Mike King and Mintz attorney Matt Gardella.
Joshua Sabari, MD Lung Cancer Specialist Answers Questions on Treating Patients with ES-SCLC
In this episode of Medtech Connect, Medtech Insight senior regulatory writer Eliza Slawther interviews MedTech Europe’s digital lead Alexander Olbrechts about the interplay between EU medical device laws with proposed horizontal regulations that impact digital devices, such as the AI Act, the Data Act and the European Health Data Space. The importance of international harmonized standards, particularly for cybersecurity, is also discussed
Quick Listen: Scrip's Five Must-Know Things:https://scrip.pharmaintelligence.informa.com/SC148297/Quick-Listen-Scrips-Five-MustKnow-Things?utm_source=sfmc&utm_medium=email&utm_campaign=Scrip%20Weekly%20Email
In this episode, HBW Insight catches up with Bayer Consumer Health’s Daniella Foster. Foster leads on the company’s public affairs and sustainability work, and so updates us on Bayer’s progress towards its net zero goals and also its Nutrient Gap Initiative, which aims to expand access to vitamins and minerals for 50 million people in underserved communities by 2030. Foster explains the business model behind sustainability, and how the company is expanding access to self-care products in other ways, for example via Rx-to-OTC switch. We also dig a bit deeper into thorny sustainability issues like greenwashing and offsetting, with Foster offering sage advice to consumer health industry colleagues.
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC148258/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss questions about Sarepta’s Duchenne muscular dystrophy gene therapy candidate (0:32), the US FDA’s efforts to simplify the COVID-19 vaccine schedule (13:15), and industry’s ideas for Medicare price negotiation system changes (24:18).Read More In The Pink SheetCBER Director Marks’ Intervention On Sarepta Gene Therapy Filing Decision Appears To Backfire: https://pink.pharmaintelligence.informa.com/PS148055/CBER-Director-Marks-Intervention-On-Sarepta-Gene-Therapy-Filing-Decision-Appears-To-BackfireIf New COVID-19 Vaccine Recommendations Land In the United States, Do They Make Sound? https://pink.pharmaintelligence.informa.com/PS148080/If-New-COVID19-Vaccine-Recommendations-Land-In-the-United-States-Do-They-Make-SoundPhRMA’s Opening Gambit: Limiting Medicare Price Setting To The IRA's Minimum Discount: https://pink.pharmaintelligence.informa.com/PS148072/PhRMAs-Opening-Gambit-Limiting-Medicare-Price-Setting-To-The-IRAs-Minimum-Discount
CNS analysts discuss neurodegenerative disorders - Parkinson’s and Alzheimer’s diseaseAlzheimer’s Disease Forecasthttps://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/alzheimers-disease/forecast/article155358.eceAlzheimer’s Disease Analysis Reporthttps://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/alzheimers-disease/disease-analysis/article209751.eceParkinson’s Disease Analysis Reporthttps://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/parkinsons-disease/disease-analysis/article218480.eceParkinson’s Disease Forecasthttps://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/parkinsons-disease/forecast/article138452.eceOther platformsApple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Huahui Health CSO Li Wenhui sits down with Scrip in the office to discuss many of the key issues such as, how he views antivirals development post-COVID? how the company’s hepatitis drugs differentiated from others? Given the current antivirals from Gilead among others, why Li believed that the antiviral development remains vital?
HPV vaccines have come a long way since they were first introduced in 2006, though not without their share of bumps and misinformation campaigns. Dr Kenneth Alexander, chief, Division of Infectious Diseases and Vice-Chair for Research at Nemours Children’s Hospital-Florida, talks to Scrip about various facets along this journey and more including how data has evolved, why the US may not be the best example to emulate for HPV vaccination, low adolescent immunization rates, steeling to deal with misinformation from anti-vaxxers and new vaccines on the horizon.
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら（複数）「FDA's Woodcock To Supreme Court: Mifepristone Ruling Will Create 'Significant Chaos’（邦題意訳：FDA幹部、最高裁のミフェプリストン審議で「深刻な混乱」を危惧）」https://pink.pharmaintelligence.informa.com/PS148056/FDAs-Woodcock-To-Supreme-Court-Mifepristone-Ruling-Will-Create-Significant-Chaos「Fifth Circuit Mifepristone Ruling May Temporarily Halt Pharmacy Dispensing, Generic Approval（邦題意訳：ミフェプリストン控訴審判決、薬局販売とジェネリック承認は一時停止か）」https://pink.pharmaintelligence.informa.com/PS148051/Fifth-Circuit-Mifepristone-Ruling-May-Temporarily-Halt-Pharmacy-Dispensing-Generic-Approval「Will Mifepristone Be Recalled If Texas Ruling Remains In Effect? Biopharma Leaders Back FDA（邦題意訳：テキサス判決、有効ならミフェプリストンはリコール必至？ バイオ製薬社長らがFDA擁護）」https://pink.pharmaintelligence.informa.com/PS148030/Will-Mifepristone-Be-Recalled-If-Texas-Ruling-Remains-In-Effect-Biopharma-Leaders-Back-FDA
Brian Yang and Dexter discuss Chinese biotech going overseas, new personal data overseas transfer standard contract, post-COVID vaccine development and CDE’s new trends.
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC148184/Quick-Listen-Scrips-Five-MustKnow-Things
Rob Krummen, the CEO of Vektor Medical, talked to Medtech Insight about Vektor’s vMap computational modeling system that relies on 12-lead electrocardiography data to identify unstable cardiac rhythms. Further ReadingFor more information on leadless Vektor Medical, atrial fibrillation and ECG technologies addressed in this interview, check out these articles from Medtech Insight.Hyfe Hopes To Unlock Utility Of Monitoring CoughsCardio Catch-Up: Updates From B-Secur, egnite, Vektor, And Other Under-The-Radar CompaniesApple Vs. AliveCor: ECG Patent Battle Headed To Import Ban DecisionAliveCor’s Smartphone-Linked ECG First Product Assessed Under UK’s Rapid HTA PilotFDA Clears Eko’s Smart Stethoscope To Detect Heart MurmursCMS Proposes National Payments For Long-Term Continuous Electrocardiogram MonitoringExec Chat: As Reimbursement Questions Get Answers, iRhythm Looks To The FutureFurther Listening:Our other podcasts are available on Apple Podcasts, Google Podcasts, SoundCloud and TuneIn- also now on Spotify Podcasts- and via smart speakers if one of these platforms has been set up as your default podcast provider.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses conference highlights from SXSW and LSI while Barnaby Pickering talks about his coverage on voice biomarkers. Hannah Daniel discusses BetterHelp’s return of $7.8m to customers to settle with FTC for sharing health data.Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in this episode:Cordio Medical Is Using Patients’ Voices To Spot Heart FailureHyfe Hopes To Unlock Utility Of Monitoring CoughsGetting Personal With Brittany Barreto: From One-Time ‘Science Hater’ To Genetics Doctorate, DNA Dating App And Women’s Health ChampionHarbinger Health CEO Stephen Hahn On Early Cancer Detection To ‘Move The Needle’ On SurvivalLSI 2023: What Ophthalmology Start-Ups Pitched To Investors At Emerging Medtech SummitLSI 2023: Intuitive Alums On Dawning Of Robotic Surgery To Digital OR FutureSpeaking To AstraZeneca And Huma About Digital’s Value For PharmaFDA Issues Framework For Use Of Digital Health Technologies In Drug Development
Quick Listen: Scrip's Five Must-Know Things:https://scrip.pharmaintelligence.informa.com/SC148184/Quick-Listen-Scrips-Five-MustKnow-Things
In this episode of Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews, Kelliann Payne, partner at Hogan Lovells. Payne advises artificial intelligence (AI) medical device manufacturers with premarket submissions and helps them navigate the complicated regulatory landscape. She laid out the current FDA regulations for AI medical devices and explained the importance of predetermined change control plans, a new cyber regulation from the Consolidated Appropriations Act of 2023.
A Man On Fire Fueled By A Mission To Find A Drug For Every Disease. by Pharma Intelligence
Find out more now about US FDA’s Orphan Drug Designation (ODD) program, which qualifies sponsors for incentives including tax credits, exemption from user fees, and more. Learn more about which orphan subsets could qualify for ODD, in your free podcast episode
최근 스위스 바젤에서 열린 바이오 유럽 스프링 행사를 취재한 Scrip Intelligence기사를 요약한 내용입니다.https://scrip.pharmaintelligence.informa.com/SC148077/Pharma-Giants-Urge-Biotechs-To-Get-In-Touch-As-Early-As-Possible
Quick Listen: Scrip's Five Must-Know Things:https://scrip.pharmaintelligence.informa.com/SC148150/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss the FDA’s upcoming advisory committee meeting for the controversial ALS cell therapy NurOwn, a proposal to batch test all drugs coming into the US amid problems conducting foreign inspections, and the FDA’s return to in-person meetings with industry.More On These Topics From The Pink Sheet:https://pink.pharmaintelligence.informa.com/PS147942/BrainStorms-ALS-Treatment-NurOwn-Filed-Over-Protest-Will-Get-US-FDA-Panel-Reviewhttps://pink.pharmaintelligence.informa.com/PS147972/Batch-Testing-Of-All-Imported-Drugs-Floated-At-House-Appropriations-Hearinghttps://pink.pharmaintelligence.informa.com/PS147971/US-FDA-Holds-First-Hybrid-Meeting-With-Industry
DMHC analysts discuss presentations from the Advanced Therapies conferenceSupporting linksCell and Gene Therapy Podcasthttps://www.biomedtracker.com/reportdetail.cfm?reportid=1683Editing The Future Reporthttps://www.biomedtracker.com/reportdetail.cfm?reportid=1608Peripheral T-Cell Lymphoma (PTCL) Market Spotlighthttps://www.biomedtracker.com/reportdetail.cfm?reportid=1050Gene, Cell, & RNA Therapy Landscape Q4 2022 Reporthttps://www.biomedtracker.com/reportdetail.cfm?reportid=1721Other platformsApple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
In this special podcast from Medtech Insight, editor Reed Miller talked to Andrie Leday, the US vice president for ambulatory surgery centers (ASCs) at Johnson & Johnson/DePuy Synthes. Leday's group is dedicated to creating a new "ecosystem" around DePuy Synthes broad range of orthopedic implants and tools to meet the demand of an aging population.Further ReadingFor more information on DePuy Synthes and the growth of ambulatory surgery centers, check out these articles from Medtech Insight.J&J Subsidiary Pays $9.75M To Resolve Kickback AllegationsAAOS 2022 Roundup: Stryker, Zimmer Biomet, J&J’s DePuy Synthes, Canary Medical Future Of Surgery: Virtual Reality, Robotics And CollaborationMinute Insight: Zimmer Biomet Adds Biointegrative Repair Products With Embody AcquisitionExec Chat: OIC Expects To Disrupt Orthopedic Surgery Market With High Value Implants Further ListeningOur other podcasts are available on Apple Podcasts, Google Podcasts, SoundCloud and TuneIn - also now on Spotify Podcasts - and via smart speakers if one of these platforms has been set up as your default podcast provider.
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC148112/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporter and editors discuss Moderna CEO’s Stéphane Bancel’s defense of his company and COVID-19 vaccine pricing at the Senate Health, Education, Labor and Pensions Committee, the NIH denying a petition to use government march-in rights for Xtandi, and Tofersen receiving a positive US FDA advisory committee recommendation for use in ALS.More on these topics from The Pink Sheet:Moderna CEO Hearing Highlights Dissatisfaction With Patient Assistance Programshttps://pink.pharmaintelligence.informa.com/PS147930/Moderna-CEO-Hearing-Highlights-Dissatisfaction-With-Patient-Assistance-ProgramsModerna CEO Reminds People About Value Of Government Negotiations At Senate Hearinghttps://pink.pharmaintelligence.informa.com/PS147939/Moderna-CEO-Reminds-People-About-Value-Of-Government-Negotiations-At-Senate-HearingAfter Xtandi, Will Government Ever Seek March-In Rights Over Drug Pricing?https://pink.pharmaintelligence.informa.com/PS147929/After-Xtandi-Will-Government-Ever-Seek-MarchIn-Rights-Over-Drug-PricingXtandi Still Faces Likely US Price Cut Even As It Avoids ‘March In’ Proceedinghttps://pink.pharmaintelligence.informa.com/PS147940/Xtandi-Still-Faces-Likely-US-Price-Cut-Even-As-It-Avoids-March-In-ProceedingAccelerated Approval Is US FDA Panel’s Preferred Path For Biogen/Ionis’s Tofersen In ALShttps://pink.pharmaintelligence.informa.com/PS147918/Accelerated-Approval-Is-US-FDA-Panels-Preferred-Path-For-BiogenIoniss-Tofersen-In-ALSAccelerated Approval: Potential Sources Of Confirmatory Evidence Weighed At Tofersen Reviewhttps://pink.pharmaintelligence.informa.com/PS147937/Accelerated-Approval-Potential-Sources-Of-Confirmatory-Evidence-Weighed-At-Tofersen-Review
Medtech Insight sat down with Brittany Barreto, CEO of FemHealth Insights, who participated in a panel discussion at SXSW 2023 on the $1t femtech industry, to talk about her journey to becoming a women’s health care champion.
In this episode, HBW Insight catches up with IQVIA Consumer Health’s vice president of Global Consulting Services, Amit Shukla, to find out how the global consumer healthcare market is doing as it comes out of the pandemic. It’s good news, Shukla reveals, based on the firm’s latest intelligence. The market grew double digits in 2022 and is predicted to grow between 5 and 6% per year in the future - even faster if we see some of the innovative switches currently in the pipeline succeed. Looking ahead, Shukla points to artificial intelligence, sustainability and popular wellness ingredients as trends to watch that will drive future market growth.
Pink Sheet reporter and editors discuss the first round of mandated Medicare inflation rebates and new guidance on price negotiations, consider the VA’s decision to cover the Alzheimer’s drug Leqembi, and the US FDA continuing to search for a cell and gene therapy office leader.
Listen to expert opinions from PPD as they discuss recent survey results which gathered insights on the current and future investment landscape from emerging to mid-size pharmaceutical and biotech companies’ perspectives.
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら 「Chinese Biotechs Ascend Deal-Making By Partnering Up Claudin 18.2 Agents（邦題意訳：中国バイオテック企業が急成長 CLDN18.2抗体で協業続々）」https://scrip.pharmaintelligence.informa.com/SC147989/Chinese-Biotechs-Ascend-DealMaking-By-Partnering-Up-Claudin-182-Agents
In this special extra episode of Medtech Insight's podcast series on cardiovascular technology, editor Reed Miller talked to Vish Charan, the divisional vice president of product development in Abbott's cardiac rhythm management division.[C#4052:Abbott] aspires to be a leader in development of "future-ready" cardiac rhythm management (CRM) devices that do not need to be frequently replaced or explanted. Late last year, Medtech Insight talked to Leonard Ganz, Abbott’s CRM business as its divisional vice president of medical affairs and chief medical officer, to talk about the company's development of leadless CRM devices, including Aveir VR, the only leadless pacemaker with unique mapping capabilities that can be easily retrieved as the patient's need for new therapies change. ([A#MT145700])To get the engineer's perspective on how Abbott is trying to keep up with [C#72:Boston Scientific] and [C#252:Medtronic] in this space, editor Reed Miller recently talked to Vish Charan, the vice president of product development in Abbott's CRM division. Charan is all too familiar with the challenges of managing traditional cardiac leads, since he started his career as an engineer working on cardiac leads at [C#1191:St. Jude Medical]; he joined Abbott as an operations leader when Abbott acquired St. Jude about six years ago. He also talked about his role with the company, the future of transvenous devices, and the potential to reach more patients earlier in the progression of arrhythmia to save lives and costs. Use the player below to hear the whole interview.Further ReadingFor more information on leadless CRM technology discussed in this interview, check out these articles from Medtech Insight.Minute Insight: Abbott Rolls Out Navitor Next-Gen TAVR System To Catch Up To Medtronic And EdwardsMedtronic’s Extravascular ICD Hits Targets In Trial; Will Soon Compete With Boston Scientific’s S-ICDExec Chat: Abbott Bets On Modular And Leadless Devices To Be The Future Of Cardiac Rhythm ManagementCardio Conversations: Abbott's Electrophysiology CMO Christopher Piorkowski On Cardiac Mapping, PFA, VT And MoreMinute Insight: Abbott’s Aveir VR To Take On Medtronic’s Micra In US Leadless Pacemaker MarketCardiovascular Catch-Up: Abbott Launches Trial Of Dual-Chamber Leadless Pacer; Cardialen Studies Low-Energy Arrhythmia Treatment; And MoreBoston Scientific Advances First ‘Modular’ Cardiac Rhythm Management SystemFurther ListeningOur other podcasts are available on Apple Podcasts, Google Podcasts, SoundCloud and TuneIn - also now on Spotify Podcasts - and via smart speakers if one of these platforms has been set up as your default podcast provider.
국가신약개발사업단이 제약바이오업계를 지원하기 위해 어떻게 진화하고 있고 어떤 신규 프로젝트를 진행하고 있는 지에 대해 이야기한 묵현상 단장 인터뷰 기사를 요약한 내용입니다.https://scrip.pharmaintelligence.informa.com/SC147745/The-Hunt-For-Big-Fish-How-KDDF-Is-Helping-Create-Korean-Deals
Gain valuable insight on the key strategies required to boost patient recruitment and retention rates, and improve diversity, in clinical trials.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights how Alife Health is using its AI-based platform for IVF to increase chances for successful pregnancies while Barnaby Pickering discusses how AI Medical Technology is using AI to detect melanoma. Reed Miller talks about weight-loss device maker Allurion Technologies’ signed SPAC deal.Medtech Insight articles addressing topics discussed in this episode:Omar Ishrak’s SPAC Buys Allurion To Support Weight-Loss Systemhttps://medtech.pharmaintelligence.informa.com/MT147624/Omar-Ishraks-SPAC-Buys-Allurion-To-Support-Weight-Loss-SystemAlife Health Leverages AI Tools For IVF To Increase Access, Improve Chances For Successful Pregnancieshttps://medtech.pharmaintelligence.informa.com/MT147660/Alife-Health-Leverages-AI-Tools-For-IVF-To-Increase-Access-Improve-Chances-For-Successful-PregnanciesAI Medical Technology Doubles Down On Melanoma With Trials And Financinghttps://medtech.pharmaintelligence.informa.com/MT147611/AI-Medical-Technology-Doubles-Down-On-Melanoma-With-Trials-And-FinancingGE HealthCare To Buy AI Imaging Firm Caption Health To Bolster Ultrasound Businesshttps://medtech.pharmaintelligence.informa.com/MT147626/GE-HealthCare-To-Buy-AI-Imaging-Firm-Caption-Health-To-Bolster-Ultrasound-BusinessMinute Insight: MeThinks Secures CE Mark For AI-based Stroke Detection Producthttps://medtech.pharmaintelligence.informa.com/MT147656/Minute-Insight-MeThinks-Secures-CE-Mark-For-AIbased-Stroke-Detection-Product
In this episode of Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews Scott Trevino, vice president of cybersecurity at TriMedX about the new cybersecurity oversight given to the FDA as a part of the 2023 Omnibus Appropriations bill passed in December.
Listen in on an illuminating and informative discussion about the role of AI in the medtech and pharma industries. Experts from IQVIA and Microsoft share their perspectives on AI’s benefits, its barriers to use, and its almost limitless possibilities for medicine.
Listen in as experts from IQVIA discuss the benefits of implementing an eQMS (electronic quality management system) in service of improving and automating computer system validation (CSV).
Why does your organization need an electronic quality management system (eQMS)? What are the uses of an eQMS and how can you ensure you’re reaping its full benefits? Listen in as experts from IQVIA discuss “How to Successfully Deploy a Fully Integrated eQMS”.
In this episode, HBW Insight chats with UK PR firm Kaizo’s associate director Kerry Lennox about consumer healthcare marketing in the post-pandemic context. With consumers bombarded by healthcare messaging and increasingly anxious about their health and wellness, Lennox explains how OTC firms can play a key role in supporting them to self-care responsibly. With trust shifting away from governments and scientific experts towards frontline healthcare professionals like pharmacists, OTC brands are becoming more important to consumers, helping them “tune back in” to science-based health and wellness while supporting this crucial part of the healthcare ecosystem.
Pink Sheet reporters and editors discuss US FDA advisory committee members’ concerns about two proposed RSV vaccines, Lilly’s plan to lower the cost of its insulin products, proposed changes to the Orphan Drug Act and the departure of the influential leader of the FDA’s Office of Neuroscience.
In this episode of Medtech Insight’s new podcast series focused on cardiovascular technology, editor Reed Miller talked to Christopher Piorkowski, Abbott's chief medical officer for electrophysiology.Recent Medtech Insight articles related to this interview:US FDA Approves Abbott’s Sensor-Enabled TactiCath AF CatheterAbbott Launches Next-Generation Of EnSite Cardiac Mapping SystemCardio Conversations: Steven Mickelsen Discusses PFA, Electrophysiology And What It Takes To Be A Physician InventorJPM 2023: Boston Scientific Sees Transformational Potential In PFA, BD Sticks To '2025' Investment StrategyExec Chat: Biosense Webster Is Ready For Next Chapters Of The Electrophysiology Story (Part II)
In this new series titled Getting Personal, we talk to new and veteran senior executives about their journeys to corporate leadership, their motivations, passions, and the peaks and valleys of running a medtech company. Medtech Insight talked with Ken Stein, Boston Scientific’s global chief medical officer about his own diagnosis with atrial fibrillation and advice for others living with the disease, innovative technologies in development at Boston Scientific, and some of his proudest and more challenging times on the job, as well as his advice for other physicians who are contemplating a move into the corporate world.Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode:
hVIVO’s Andrew Catchpole Talks Human Challenge Trials, From COVID-19 to Malaria by Pharma Intelligence
Citeline’s Brian Yang and Dexter Yan discuss recent China biotech hot topics incl. antibody drug conjugate deals, China’s planning to ban gene editing export, volume-based procurement in 2023 and China biotech’s paradox and outlooks in the new year of rabbit.
Pink Sheet reporters and editor discuss learnings from a generic drug industry trade association conference, as well as FDA Commissioner Robert Califf’s ideas for advisory committee changes and using emergency use authorizations in non-COVID-19 areas.
Citeline managing editor Brain Yang discusses with Insilico Co-CEO and Head of Drug Discovery Feng Ren on artificial intelligence-assisted drug discovery for idiopathic pulmonary fibrosis.
China’s Akeso has made a name for itself on the world stage by cutting a potential $5bn licensing deal with US biotech Summit in December 2022. Michelle Xia, founder, chairwoman and CEO of the biopharma, is beginning to look beyond the deal, describing it one of the first steps for Akeso to develop and commercialize innovative drugs globally on its own.Time marks:IntroductionLicensing deal with Summit Therapeutics (00:20) Latest progress of the partnership (01:33)Ivonescimab’s potential breakthrough (03:21)Akeso’s journey (04:51)Platform buildup and choice of targets (07:22)Cadonilimab versus PD-1 (11:32)Licensing prospects of cadonilimab (14:43)Bispecific antibody versus ADC (17:10)Rationale behind deal-making (19:50)Go global on its own (22:20)Closing
https://scrip.pharmaintelligence.informa.com/SC147933/Quick-Listen-Scrips-Five-MustKnow-Things
Quick Listen: Scrip’s Five Must-Know Things:https://scrip.pharmaintelligence.informa.com/SC147899/Quick-Listen-Scrips-Five-MustKnow-Things
Announcing the 2nd Citeline Pharma Intelligence Awards Japan, which will take place in Tokyo on 17 October. Entries are now open with a deadline of 10 July. Check out the links below for all the information on categories, judges, how to enter, table bookings and sponsorship opportunities. See you in Tokyo! English-language event site is here:https://pharmaintelligence.informa.com/citelinepharmaintelligenceawards2023Japanese-language event site is here:https://pharmaintelligence.informa.com/ja-jp/citelinepharmaintelligenceawards2023https://scrip.pharmaintelligence.informa.com/SC147763/Citeline-Pharma-Intelligence-Awards-Japan-2023-Entries-Now-Open
DMHC’s financial analysts discuss M&As, the vaccine market, and biosimilars by Pharma Intelligence
In this episode, HBW Insight interviews Per Rehné, CEO of UK-based microbiome specialists Clasado Biosciences, about the exciting world of prebiotics. Essentially food for your gut microbiome, prebiotics have benefitted from a worldwide boom in preventative health in recent years, as well as a critical mass of clinical research showing the significant role that the gut plays in health, immunity and even stress and anxiety. In this fascinating discussion, Rehné explains the science behind prebiotic supplementation, as well as the regulatory environment in the European Union that makes marketing such supplements challenging, to say the least. We also dive into the current and future growth and innovation opportunities that prebiotics represent for the consumer health industry, which Clasado supplies, as well as marketing its own Bimuno branded product in the UK and beyond.
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC147859/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.
In this episode of new podcast series Medtech Connect, Medtech Insight’s regulatory writer for Europe, Eliza Slawther, interviews Alexander Olbrechts, director for digital health at the European trade body Medtech Europe, to find out more about the proposed European Health Data Space initiative and what it means for the medical device industry.
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「J.P. Morgan Was Back, But Not With A Roar（邦題意訳：帰ってきたJPモルガンカンファレンス、ただし勢いはやや控えめ）」https://scrip.pharmaintelligence.informa.com/SC147649/JP-Morgan-Was-Back-But-Not-With-A-Roar「The Best Of J.P. Morgan – Valuations, Deals And The IRA（邦題意訳：JPモルガン総まとめ 企業評価から提携、IRAまで）」https://scrip.pharmaintelligence.informa.com/SC147668/The-Best-Of-JP-Morgan--Valuations-Deals-And-The-IRA【コンサルティングサービスのご紹介】ファーマインテリジェンスのコンサルティングチームは、製薬やバイオ技術、医療機器といった分野で活躍する企業のお客様と緊密に連携し、個別の課題をピンポイントで解決します。開発途中の薬剤に関するビジネス機会評価や売上予測、価格予測をはじめ、医療経済評価モデルや臨床試験計画、ベンチマークの策定、協業戦略の策定やポートフォリオの優先順位評価など、幅広いニーズに応え、エビデンスに基づいた意思決定を支援します。今解決したい課題をお持ちの方、ぜひご相談ください。担当者：今堀 逸太郎（itsutaro.imahori@informa.com）
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC147782/Quick-Listen-Scrips-Five-MustKnow-Things
Dr. Cronin provides her perspectives on identification, treatment, and management of oHCM patients using the novel cardiac myosin inhibitor, mavacamten.Lynn Cronin, MD, FACC is board-certified in cardiology with clinical interests in adult congenital heart disease, valvular heart disease, and chronic ischemic heart disease. She is affiliated with multiple hospitals in the Holland, MI area including Spectrum Health.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent CES 2023 conference in Las Vegas. Reed Miller discusses Abbott’s VR partnership with the Blood Centers for America and Barnaby Pickering highlights Bayer’s jump into medtech with its buyout of Blackford Analysis.Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in this episode:
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent CES 2023 conference in Las Vegas. Reed Miller discusses Abbott’s VR partnership with the Blood Centers for America and Barnaby Pickering highlights Bayer’s jump into medtech with its buyout of Blackford Analysis.Medtech Insight articles addressing topics discussed in this episode:CES 2023: Competition Spikes In Cuffless Blood Pressure Monitoringhttps://medtech.pharmaintelligence.informa.com/MT147552/CES-2023-Competition-Spikes-In-Cuffless-Blood-Pressure-MonitoringCES 2023 Turnout Will Double Last Year’s; AARP AgeTech Takes Center Stagehttps://medtech.pharmaintelligence.informa.com/MT147472/CES-2023-Turnout-Will-Double-Last-Years-AARP-AgeTech-Takes-Center-StageCES 2023: Abbott, Seth Rogen, An Avatar For Old Folks, And A Smart Toilet For The Heartbrokenhttps://medtech.pharmaintelligence.informa.com/MT147512/CES-2023-Abbott-Seth-Rogen-An-Avatar-For-Old-Folks-And-A-Smart-Toilet-For-The-HeartbrokenCES 2023: Tech Innovations For Simulated Heart Device Testing, Seizure Prediction, And Guiding The Visually Impairedhttps://medtech.pharmaintelligence.informa.com/MT147529/CES-2023-Tech-Innovations-For-Simulated-Heart-Device-Testing-Seizure-Prediction-And-Guiding-The-Visually-ImpairedMinute Insight: Abbott Launches Mixed-Reality Experience To Make Blood Donation Easierhttps://medtech.pharmaintelligence.informa.com/MT147507/Minute-Insight-Abbott-Launches-Mixed-Reality-Experience-To-Make-Blood-Donation-EasierFDA Launches New Webpage Dedicated To AR And VR Medical Deviceshttps://medtech.pharmaintelligence.informa.com/MT147421/FDA-Launches-New-Webpage-Dedicated-To-AR-And-VR-Medical-DevicesExpert: Cybersecurity Requirements In Omnibus Bill Will Provide Visibility For Industryhttps://medtech.pharmaintelligence.informa.com/MT147516/Expert-Cybersecurity-Requirements-In-Omnibus-Bill-Will-Provide-Visibility-For-IndustryMajor NIH Health And Medical Study Returns First Results To 155,000 Peoplehttps://medtech.pharmaintelligence.informa.com/MT147460/Major-NIH-Health-And-Medical-Study-Returns-First-Results-To-155000-PeopleAll Eyes On US Patent And Trademark Board As ITC Approves Apple Watch Import Banhttps://medtech.pharmaintelligence.informa.com/MT147500/All-Eyes-On-US-Patent-And-Trademark-Board-As-ITC-Approves-Apple-Watch-Import-BanMinute Insight: Drug Giant Bayer Jumps Into Medtech Via AI Acquisitionhttps://medtech.pharmaintelligence.informa.com/MT147545/Minute-Insight-Drug-Giant-Bayer-Jumps-Into-Medtech-Via-AI-Acquisition
https://scrip.pharmaintelligence.informa.com/SC147711/Quick-Listen-Scrips-Five-MustKnow-Things
Post-ASH report https://service.datamonitorhealthcare.com/hkc/thought-leadership/article244408.eceAML disease analysis report https://service.datamonitorhealthcare.com/hkc/disease/oncology/leukemia/acute-myeloid-leukemia/disease-analysis/article214159.eceMultiple myeloma disease analysis report https://service.datamonitorhealthcare.com/hkc/disease/oncology/other-hematological-cancers/multiple-myeloma/disease-analysis/article219424.eceCLL disease analysis report https://service.datamonitorhealthcare.com/hkc/disease/oncology/leukemia/chronic-lymphocytic-leukemia/disease-analysis/article222425.eceOther platforms in addition to SoundCloud:Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNzTuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
https://scrip.pharmaintelligence.informa.com/SC147669/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss the take-aways from Leqembi’s approval as an Alzheimer’s treatment, the new timeline for information collection and comment on Medicare price negotiations, and the reasons a generic drugs trade association CEO departed.
In this first episode of Medtech Connect, Medtech Insight’s regulatory reporter Hannah Daniel interviews Foley and Lardner partner Kyle Faget about the complexities behind regulating software as a medical device (SaMD). Many companies are unsure if their software is even regulated by the FDA, let alone how to go about the approval process. From managing cybersecurity risks to navigating digital health policy, Faget does it all, and she gives us insight into the regulatory landscape of SaMD in this month’s episode.
In this episode, HBW Insight chats with Louise Witter, director and principal consultant at UK-based Chemical Legislation Professionals, about proposed revisions to the EU’s Classification, Labeling and Packaging Regulation (CLP) to introduce new hazard classes, including for endocrine disruptors. The discussion, just prior to the European Commission’s adoption of the proposal on 19 December, ranges from implications for cosmetics companies to reflections on the EU Green Deal, which may be outpacing scientific consensus and endangering an already beleaguered and highly regulated chemicals industry.
Pink Sheet reporters and editors discuss a projected decline in accelerated approvals by the US FDA, a new CMS proposed rule requiring generic drug cost sharing tiers, and the negative advisory committee recommendation for Cytokinetics’ proposed heart failure treatment.
Listen Citeline's Executive Director of Clinical Intelligence, Karen Currie and Executive Editor Commerical/R&D, Mary Jo Laffler discussing the hints and tips for entering the Citeline Awards 2023, as well as information on new categories.Find out more on our website:https://pharmaintelligence.informa.com/citelineawards2023#CitelineAwards
SK바이오팜의 오픈이노베이션 전략과 신약개발 성공요인에 대한 Scrip의 맹철영 SK바이오팜 신약개발부문장(CTO) 인터뷰 기사 내용입니다.https://scrip.pharmaintelligence.informa.com/SC146933/SK-Biopharms-CTO-On-Diversity-In-Open-Innovation
Quick Listen: Scrip's Five Must-Know Thingshttps://scrip.pharmaintelligence.informa.com/SC147511/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor consider the line between therapeutic innovation and affordability, the Association for Accessible Medicines searching for a new CEO, and questions about IND regulations and drug repurposing.
Eyestem’s founder and CEO, Dr Jogin Desai, talks to Scrip about progress made by the firm’s experimental treatment for dry age-related macular degeneration, cell and gene therapy pricing considerations and the wider competitive landscape. The company is also developing treatments for retinitis pigmentosa and idiopathic pulmonary fibrosis.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent HLTH conference in Las Vegas. Reed Miller and Barnaby Pickering offer an overview of the highly competitive diabetes tech market. We also talk about digital health in Germany and Europe.
Medtech Insight articles addressing topics discussed in this episode:
HLTH Conference Promises Festival Vibe On One Big Stage; Health Equity, Women’s Health, Digital Health https://medtech.pharmaintelligence.informa.com/MT146035/HLTH-Conference-Promises-Festival-Vibe-On-One-Big-Stage-Health-Equity-Womens-Health-Digital-Health
HLTH 2022 Roundup: Mirvie, Grail, Biofourmis, Komodo Health, Babson Diagnostics https://medtech.pharmaintelligence.informa.com/MT146060/HLTH-2022-Roundup-Mirvie-Grail-Biofourmis-Komodo-Health-Babson-Diagnostics
HLTH 2022 Roundup: CEOs Of BD And Google Cloud On Innovation, Interoperability, AI https://medtech.pharmaintelligence.informa.com/MT147361/HLTH-2022-Roundup-CEOs-Of-BD-And-Google-Cloud-On-Innovation-Interoperability-AI
Medtech Monthly, Ep. 4: The Future Of Diabetes Tech https://medtech.pharmaintelligence.informa.com/MT146000/Medtech-Monthly-Ep-4-The-Future-Of-Diabetes-Tech
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions 「（邦題意訳）リアルワールド、見えた弱点 米国FDAの承認で比較可能性がネックに」 https://pink.pharmaintelligence.informa.com/PS147051/The-Real-World-Is-Not-Enough-Comparability-Is-Common-Obstacle-For-RWE-In-US-FDA-Decisions
https://scrip.pharmaintelligence.informa.com/SC147431/Quick-Listen-Scrips-Five-MustKnow-Things
Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC147398/Quick-Listen-Scrips-Five-MustKnow-Things
Suzhou and Boston-based Harbour BioMed recently shifted strategy, divesting its site in Suzhou to WuXi in a bid to be “more focused, efficient and nimble” to emerge stronger post-pandemic, says the company founder, chairman and CEO Jinsong Wang in an extensive interview.
US-based Vaxxinity Inc’s co-founder and CEO Mei Mei Hu and her team are developing peptide-based vaccines to treat or prevent chronic illnesses like cardiovascular disease and infectious ones like COVID-19. Scrip spoke to her on when data readouts from these immunotherapeutic candidates can be expected and her plans to make them accessible. Whether or not UB-313 will prove to be the first choice to prevent migraines and VXX-401, a vaccine to prevent hypercholesterolemia, will be cheaper than statins, only time will tell. But Hu and her team are trying.
レポート『臨床試験を牽引するアジア太平洋地域～Asia Pacific as a Clinical Trials Powerhouse（2022年10月発行）』を要約し、短い音声ファイルにまとめました。臨床試験データベース「Trialtrove」のデータを基に、2012年から2021年の10年間におけるAPAC（アジア太平洋地域）の臨床試験状況を分析しています。
フルレポートをお読みになりたい方は、下記のURLからダウンロードしてください。APACにおける治験依頼者、対象疾患、試験の種類などについても詳しく解説しています。
【日本語版】 https://images.intelligence.informa.com/Web/InformaUKLimited/%7Bc5d2830a-4459-414d-ae16-795bbaba8aaf%7D_J202012-0049-21_APAC_paper_final_ORIGINAL_rev1012_JP.pdf
【英語版】 https://images.intelligence.informa.com/Web/InformaUKLimited/%7B5aa69e1c-6980-44db-94f8-6b82f411e712%7D_Asia_Pacific_Clinical_Trials_Powerhouse_Whitepaper_FINAL_EN.pdf
★臨床試験データベース「Trialtrove」 https://pharmaintelligence.informa.com/ja-JP/products-and-services/clinical-planning/trialtrove
머크가 400억달러 규모의 씨젠 인수에서 손을 떼는 등 빅파마들이 여전히 인수합병에 나서는 것을 자제하고 있다는 Scrip 기사를 요약한 내용입니다. https://scrip.pharmaintelligence.informa.com/SC147191/Pfizer-Leads-Big-Pharma-MA-In-2022--But-Is-There-More-To-Come
Pink Sheet reporters and editor discuss the impact of the midterm elections on the US Food and Drug Administration, the Inflation Reduction Act’s effects on drug development, and adjustments to the FDA’s expanded access guidance.
Accenture's Petra Jantzer on M&A trends and what it means for execs by Pharma Intelligence
https://scrip.pharmaintelligence.informa.com/SC147319/Quick-Listen-Scrips-Five-MustKnow-Things
International Vaccine Institute Director General Jerome Kim talks about what role IVI has been playing in Korea’s vaccine strategy, what makes the country an ideal place for a global vaccine hub and why this is significant for the country.
https://scrip.pharmaintelligence.informa.com/SC147314/How-IVI-Is-Helping-To-Shape-Koreas-Vaccine-Ambitions
In this edition of the Medtech Monthly podcast, Medtech Insight editor Reed Miller talks to UK-based reporter Barnaby Pickering to get a update on the state of diabetes tech and future of this dynamic market.
Articles reference in this podcast include:
Bigfoot Looks To Unlock More Effective Treatments For Type II Diabetics https://medtech.pharmaintelligence.informa.com/MT145973/Bigfoot-Looks-To-Unlock-More-Effective-Treatments-For-Type-II-Diabetics
Dexcom’s G7 Expands Globally After A Long Wait https://medtech.pharmaintelligence.informa.com/MT145894/Dexcoms-G7-Expands-Globally-After-A-Long-Wait
Minute Insight: Indigo Diabetes Starts Human Trial Of Subcutaneous Glucose Monitor https://medtech.pharmaintelligence.informa.com/MT145875/Minute-Insight-Indigo-Diabetes-Starts-Human-Trial-Of-Subcutaneous-Glucose-Monitor
Class-Action Suit Alleges Medtronic’s Rosy Forecast For MiniMed780G Misled Investors https://medtech.pharmaintelligence.informa.com/MT145828/Class-Action-Suit-Alleges-Medtronics-Rosy-Forecast-For-MiniMed780G-Misled-Investors
Published ADAPT Results Further Support Medtronic’s Highly Anticipated 780G https://medtech.pharmaintelligence.informa.com/MT145803/Published-ADAPT-Results-Further-Support-Medtronics-Highly-Anticipated-780G
Insulet Receives FDA Clearance For Omnipod For Children Ages 2 And Up https://medtech.pharmaintelligence.informa.com/MT145733/Insulet-Receives-FDA-Clearance-For-Omnipod-For-Children-Ages-2-And-Up
Medtech Monthly, Ep. 2: Where Does Diabetes Tech Stand In 2022? https://medtech.pharmaintelligence.informa.com/MT145676/Medtech-Monthly-Ep-2-Where-Does-Diabetes-Tech-Stand-In-2022
Relevant Meddevicetracker market reports:
Diabetes Management: Insulin Pumps Market https://www.meddevicetracker.com/ReportDetail.cfm?ReportID=503
Diabetes Management: Blood Glucose Monitoring Devices Market https://www.meddevicetracker.com/ReportDetail.cfm?ReportID=463
Digital Health: Diabetes Apps and Virtual Coaching https://www.meddevicetracker.com/ReportDetail.cfm?ReportID=439
https://scrip.pharmaintelligence.informa.com/SC147283/Quick-Listen-Scrips-Five-MustKnow-Things
https://scrip.pharmaintelligence.informa.com/SC147243/Quick-Listen-Scrips-Five-MustKnow-Things
Medtech Insight’s new series Getting Personal features conversations with new and veteran senior executives about their journeys to corporate leadership, their motivations, passions and the peaks and valleys of running a medtech company. Daniel Hawkins, founder and CEO of Avail Medsystems discussed how his company virtually connects health care professionals into the operating suite and allows for real-time collaboration.
Pink Sheet reporters and editors discuss lessons from the public hearing on the proposed withdrawal of the preterm birth prevention drug Makena, FDA Commissioner Califf’s opinion that industry is not meeting expectations with accelerated approval confirmatory studies, and agency efforts to clarify that staff is paying attention to comparative claims in product ads.
In this month’s Digital Health Roundup, Medtech Insight’s Reed Miller offers a recap from the recent TCT 2022 meeting and talks about Butterfly Network’s expansion into Africa while Marion Webb highlights her interview with Aidoc’s CEO Elad Walach discussing plans for the AI-based software company.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode: AI-based Start-Up Aidoc Has Big Plans For Health Integration Beyond Reading Radiology Scans Minute Insight: Butterfly Deploys POC Ultrasound In Kenya To Support New Mothers Cardio Catch-Up: Medtech Innovation Takes Center Stage At TCT 2022
In this new series titled Getting Personal, we talk to new and veteran senior executives about their journeys to corporate leadership, their motivations, passions, and the peaks and valleys of running a medtech company. Medtech Insight sat down with Mike Mussallem, CEO of Edwards Lifesciences, the leading seller of transcatheter aortic valve replacement (TAVR) devices, at the company’s Irvine, CA-based headquarters.
https://scrip.pharmaintelligence.informa.com/SC147207/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss Michelle McMurry-Heath’s surprising departure as head of a top biotech industry trade association, preview the FDA hearing to withdraw the preterm birth prevention drug Makena, and consider Amylyx’s Relyvrio seemingly opening a wider path to gather confirmatory evidence for approval.
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら A Banner Moment For Alzheimer's Positions Eisai/Biogen At The Head Of The Pack （邦題意訳「アルツハイマー治療薬 エーザイとバイオジェンに競争の栄冠」） https://scrip.pharmaintelligence.informa.com/SC147116/A-Banner-Moment-For-Alzheimers-Positions-EisaiBiogen-At-The-Head-Of-The-Pack
Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever （邦題意訳「レカネマブ、史上最速で迅速承認から正式承認の切り替えを達成か」） https://pink.pharmaintelligence.informa.com/PS147077/Lecanemab-Conversion-From-Accelerated-To-Full-Approval-Could-Be-Among-Fastest-Ever
【コンサルティングサービスのご紹介】 ファーマインテリジェンスのコンサルティングチームは、製薬やバイオ技術、医療機器といった分野で活躍する企業のお客様と緊密に連携し、個別の課題をピンポイントで解決します。開発途中の薬剤に関するビジネス機会評価や売上予測、価格予測をはじめ、医療経済評価モデルや臨床試験計画、ベンチマークの策定、協業戦略の策定やポートフォリオの優先順位評価など、幅広いニーズに応え、エビデンスに基づいた意思決定を支援します。今解決したい課題をお持ちの方、ぜひご相談ください。 担当者：今堀 逸太郎（itsutaro.imahori@informa.com）
글로벌 제약사로 성장하기 위해 보령의 R&D 전략이 어떻게 변화하고 있는 지 Scrip Intelligence의 김봉석 보령 R&D 센터장 인터뷰 기사를 요약한 내용입니다.
https://scrip.pharmaintelligence.informa.com/SC146392/Boryungs-TwoTrack-RD-Strategy-Innovative-Drugs-And-Cash-Cows
In this episode, HBW Insight finds out about the upcoming Global Self-Care Federation World Congress, which will take place next Wednesday and Thursday in Cape Town, South Africa. We find out about what’s on the conference agenda from GSCF director general Judy Stenmark, and what the location means to local industry from Self-Care Association of South Africa CEO Nicola Brink.
https://scrip.pharmaintelligence.informa.com/SC147183/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss new developments in the Makena withdrawal case, FDA taking small steps toward resuming in-person meetings at its headquarters, and the agency finally releasing the FY 2023 user fee rates.
MagGenome Pvt Ltd, an Indian biotech which develops magnetic nanoparticle-based products for therapeutics and molecular diagnostics, is in the early research stage for a nanoparticle-based adjuvant for vaccines. Scrip spoke to founder Sam Santhosh and CEO and chief scientific officer CN Ramchand to gauge the enabling environment being created in India for cell and gene therapy companies, the increasing linkages between novel drug discovery and diagnostics and the promise of nanotech. On the lookout for start-ups to incubate, Santhosh also spoke about bridging the industry-academia gap via the Charotar University of Science and Technology (CHARUSAT).
CanSino’s Yu discusses its approval of Covidecia Air, the world’s first inhaled COVID-19 vaccine, overseas clinical trials and its original Ad5-nCOV vaccine Covidecia commercial launch in emerging markets.
https://scrip.pharmaintelligence.informa.com/SC147139/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss the newly approved ALS drug Relvyrio, the promising data on the Alzheimer’s drug lecanemab, and CMS’s efforts to build the drug price negotiation program
Learn the short- and long-term benefits and considerations for incorporating the use of real-world data (RWD) early on in clinical research.
In the second episode featuring highlights from a recent panel on mRNA manufacturing, experts from BioNTech, Sanofi, eTheRNA, IAVI and TriLink Biotechnologies will discuss the role of stability, CDMO partnerships, emerging mRNA platforms and the importance of locking these down early.
Following the global pandemic and success of mRNA technology in vaccines immunizing against severe COVID-19 infections, a panel of experts from BioNTech, Sanofi, eTheRNA, IAVI and TriLink Biotechnologies came together to discuss how industry can ease the bottlenecks that currently exist to wider usage of mRNA. The first of two podcast episodes featuring highlights will focus on strengthening supply chains, drug substance and drug product manufacturing.
Understand the history, journey, and implications of the Prescription Drug Fee User Act (PDFUA) as it approaches its deadline for renewal.
Explore real-world data (RWD) quality and curation considerations beyond the guidance offered by US FDA to overcome common data processing pitfalls.
Understand the evolution of FDA’s real-world evidence (RWE) framework and track the trends toward incorporating its use into clinical studies.
Post-ESMO report: https://www.biomedtracker.com/reportdetail.cfm?reportid=1686
Other platforms:
Apple Podcasts - podcasts.apple.com/us/podcast/phar…sts/id923189836 Google Podcasts - podcasts.google.com/feed/aHR0cHM6Ly…C9zb3VuZHMucnNz TuneIn - tunein.com/podcasts/Business--…-Podcasts-p1140128/ Spotify Podcasts - open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
https://scrip.pharmaintelligence.informa.com/SC147102/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s declaration that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 For listeners in pharma industry, we deliver a summarized insight from Scrip and Pink Sheet in Japanese, one story at a time. 今回取り上げた記事はこちら The selected article for this episode is: Bharat Biotech Debuts World’s First Exclusively Intranasal COVID-19 Vaccine （邦題意訳「世界初、経鼻投与型コロナワクチンの希望と課題は」） https://scrip.pharmaintelligence.informa.com/SC147011/Bharat-Biotech-Debuts-Worlds-First-Exclusively-Intranasal-COVID-19-Vaccine
【コンサルティングサービスのご紹介】 ファーマインテリジェンスのコンサルティングチームは、製薬やバイオ技術、医療機器といった分野で活躍する企業のお客様と緊密に連携し、個別の課題をピンポイントで解決します。開発途中の薬剤に関するビジネス機会評価や売上予測、価格予測をはじめ、医療経済評価モデルや臨床試験計画、ベンチマークの策定、協業戦略の策定やポートフォリオの優先順位評価など、幅広いニーズに応え、エビデンスに基づいた意思決定を支援します。今解決したい課題をお持ちの方、ぜひご相談ください。 担当者：今堀 逸太郎（itsutaro.imahori@informa.com）
Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC147080/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editors discuss the role of real world evidence in US FDA product decisions, staffing and other problems that are limiting the agency’s ability to implement lessons from the pandemic, and updates to COVID-19 vaccine adverse event reporting requirements.
Medtech Insight’s EU Regulation Basics 2: Key Organizations And Documents And The Four Risk Classes by Informa
In this month’s Digital Health Roundup, Medtech Insight’s Reed Miller talks about Biotronik’s and AliveCor’s partnership, Marion Webb profiles three agetech companies, and Barnaby Pickering talks Swiss medtech awards and smart hospitals.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode: Minute Insight: AliveCor And Biotronik Pilot Combined Remote Cardiac Monitoring Solution Exec Chat: ‘Wow Factor’ Is Important In Medtech Investment, But It’s Not Everything Says Ceros CEO ‘The Story That No One Likes To Hear’: Investors Looking For Surer Bets In Health Tech After Record 2021’ MedRhythms On First-To-Market Track With Prescription Music Therapy For Chronic Stroke VR Technology Offers Real-World View Of What It’s Like To Live With Age-Related Impairments De Oro Devices’ NexStride To Help Freezing Gait Is Targeting Expansion To Other Diseases, Software Integration Minute Insight: Amazon Gives Up On Amazon Care, Shifts Focus To Acquisitions Medtech Innovators Take on Fall Prevention, Mobility Challenges For Older Adults De Oro Devices’ NexStride To Help Freezing Gait Is Expansion To Other Diseases, Software Integration
중국 의약품 관련 미국의 규제 환경과 이로 인한 영향은 무엇인 지 베이진의 연구개발 총괄 라이 왕 박사의 Pink Sheet 인터뷰 기사를 요약한 내용입니다. https://pink.pharmaintelligence.informa.com/PS146934/BeiGene-Head-of-RD-Lai-Wang-On-Going-Global
Quick Listen: Scrip's Five Must-Know Things
https://scrip.pharmaintelligence.informa.com/SC147037/Quick-Listen-Scrips-Five-MustKnow-Things?utm_source=sfmc&utm_medium=email&utm_campaign=Scrip%20Weekly%20Email
Pink Sheet reporters and editors discuss the positive advisory committee recommendation for Amylyx’s proposed ALS treatment, the striking drop in clinical trials conducted in Russia following the start of the war in Ukraine, and questions about Medicare price negotiations avoiding political influence.
In this new series titled Getting Personal, we talk to new and veteran executives about the trials and tribulations in running a company while exploring their own motivations and passions. In this first edition, we talk to Sidney Collin, co-founder and CEO of De Oro Devices. Collin invented NexStride, a portable device to help overcome freezing of gait in Parkinson’s disease patients, while studying biomedical engineering at the California Polytechnic State University in 2018.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Medtech Innovators Take on Fall Prevention, Mobility Challenges For Older Adults De Oro Devices’ NexStride To Help Freezing Gait Is Expansion To Other Diseases, Software Integration
• What are the benefits of the decentralized clinical trial (DCT) model? • What are the barriers to sites and investigators participating in DCTs? • What support measures are critical to DCT success? • What is the outlook for DCTs during the coming 3 – 5 years and how can sites and investigators contribute to their evolution?
Listen to a lively discussion of these questions and more, as industry experts discuss DCT and hybrid clinical trial models. Download and listen to your free podcast from Scrip, presented in partnership with ICON.
In this episode, HBW Insight talks to Haleon’s global head of regulatory intelligence and policy, Ian Urquhart, about the innovative and flexible approaches that regulators took to ensuring access to medicines during the coronavirus pandemic. Urquhart speaks about his work with the Global Self-Care Federation, where the regulatory affairs committee which he chairs has been looking into what happened during the pandemic and drawing lessons for the future. Strengthening supply chains, Rx-to-OTC switch and e-commerce are all on the agenda for the organization, which has published a series of papers in these areas to inform future self-care policy and regulation across the world.
https://scrip.pharmaintelligence.informa.com/SC146996/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporters and editor discuss the emergency use authorization for updated COVID-19 vaccines, the new FDA Overdose Prevention Framework, and key decisions and deadlines upcoming in September.
Gene, Cell, & RNA Therapy Landscape Q2 2022 - https://www.biomedtracker.com/reportdetail.cfm?reportid=1669 Gene, Cell, & RNA Therapy Landscape Q1 2022 - https://www.biomedtracker.com/reportdetail.cfm?reportid=1646 Editing The Future - https://www.biomedtracker.com/reportdetail.cfm?reportid=1608
Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Listen to highlights of the 64th Annual Scientific Meeting of the American Headache Society.
Listen to highlights of the 64th Annual Scientific Meeting of the American Headache Society.
Listen to highlights of the 64th Annual Scientific Meeting of the American Headache Society.
Listen to highlights of the 64th Annual Scientific Meeting of the American Headache Society.
https://scrip.pharmaintelligence.informa.com/SC146959/Quick-Listen-Scrips-Five-MustKnow-Things
Medtech Insight’s New EU Regulatory/Reimbursement Writer, Eliza Slawther, And EU Basics by Informa
In this episode, HBW Insight speaks to Elan Sudberg, CEO of Alkemist Labs and chair of the American Herbal Product Association’s Psychedelic Plants and Fungi committee. Sudberg talks about the founding of the committee and the regulatory hoops that companies will have to jump through to research and develop psychedelic supplements, as well as the benefits that psychedelic plants are thought to have on human health.
Pink Sheet reporter reviews recent stories on US FDA concerns about the EU data protection regulation, the US enacting the Medicare price negotiation law, warning letters sent to Emergent BioSolutions and ImprimisRx, and Amylyx’s ALS drug going in front of the Institute for Clinical and Economic Review.
Brian Yang and Dexter Yan discuss hot topics in China's biopharma industry in July 2022 in this new Chinese language podcast chat series.
Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.
유한양행이 글로벌 제약사로 성장하기 위해 선택한 오픈이노베이션 전략과 R&D 전략에 대해 유한양행의 중앙연구소장이신 오세웅 전무님을 인터뷰한 Scrip기사를 요약한 내용입니다.
https://scrip.pharmaintelligence.informa.com/SC146768/No-Future-Without-New-Drugs-Yuhan-CSO-On-Open-Innovation-Strategy
Korean-language podcast summarising a recent article from Scrip.
In this month’s Digital Health roundup, Medtech Insight’s Reed Miller talks about iRhythm and Withings’ smartwatches business, Barnaby Pickering reviews digital therapeutics Pear Therapeutics’ restructuring, and Marion Webb presents highlights from her new series on Agetech.
Medtech Insight articles addressing topics discussed in this episode:
Medtech Innovators Take on Fall Prevention, Mobility Challenges For Older Adults https://medtech.pharmaintelligence.informa.com/MT145689/Agetech-Innovators-Take-On-Fall-Prevention-Mobility-Challenges-For-Older-Adults
The Agetech Revolution: Telehealth Boom Opens New Doors To $8Tn Economy For Patients 50+ https://medtech.pharmaintelligence.informa.com/MT145664/The-Agetech-Revolution-Telehealth-Boom-Opens-New-Doors-To-8Tn-Economy-For-Patients-50
FDA Clears iRhythm’s Afib-Detecting Wearable Running Software Co-Developed By Verily https://medtech.pharmaintelligence.informa.com/MT145646/FDA-Clears-iRhythms-Afib-Detecting-Wearable-Running-Software-Co-Developed-By-Verily
Minute Insight: Withings Teams Up With Medable On Decentralized Trials https://medtech.pharmaintelligence.informa.com/MT145641/Minute-Insight-Withings-Teams-Up-With-Medable-On-Decentralized-Trials
Minute Insight: Are Things Going Pear-Shaped For Digital Therapeutics? https://medtech.pharmaintelligence.informa.com/MT145653/Minute-Insight-Are-Things-Going-Pear-Shaped-For-Digital-Therapeutics
https://scrip.pharmaintelligence.informa.com/SC146845/Quick-Listen-Scrips-Five-MustKnow-Things
In this episode, HBW Insight talks to Mihai Inceu about the challenges of innovating in Europe’s thriving food supplements market. Senior Regulatory Affairs Officer at Jensen R+, Inceu highlights some of the issue companies face in putting new wellness products onto the European market, particularly if they want to make health claims for herbal ingredients, also known as botanicals. As well as giving good advice about how to avoid getting into trouble with regulators, Inceu also points to some of the latest trends in this dynamic consumer healthcare space.
: 世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 A Japanese-language summary of selected content from Scrip and Pink Sheet, one story at a time. 今回取り上げた記事はこちら The article for this episode is: MSD’s Asia Pacific Chief On Lagevrio’s Gains In Clinical Utility Amid Paxlovid Luster （邦題意訳「アジアの医療現場で躍進 コロナ治療薬ラゲブリオの強みと戦略は」） https://scrip.pharmaintelligence.informa.com/SC146732/MSDs-Asia-Pacific-Chief-On-Lagevrios-Gains-In-Clinical-Utility-Amid-Paxlovid-Luster 【コンサルティングサービスのご紹介】 ファーマインテリジェンスのコンサルティングチームは、製薬やバイオ技術、医療機器といった分野で活躍する企業のお客様と緊密に連携し、個別の課題をピンポイントで解決します。開発途中の薬剤に関するビジネス機会評価や売上予測、価格予測をはじめ、医療経済評価モデルや臨床試験計画、ベンチマークの策定、協業戦略の策定やポートフォリオの優先順位評価など、幅広いニーズに応え、エビデンスに基づいた意思決定を支援します。今解決したい課題をお持ちの方、ぜひご相談ください。 担当者：今堀 逸太郎（itsutaro.imahori@informa.com）
Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC146801/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporter looks at the biggest US FDA and pharma industry stories of the week, including the status of US FDA user fee renewal legislation, new real-time oncology review program guidance, Biogen’s ALS accelerated approval play, and Teva settling opioid litigation.
Gennova Biopharma’s founder CEO Sanjay Singh talks to Scrip on developing the first Indian and the world’s third mRNA vaccine against COVID-19, following Moderna and Pfizer. After a couple of years in the US at The National Institutes of Health, he returned to set up the company, which is looking at using the technology against cancer and infectious diseases like dengue and is now being sought by funds/companies for an equity stake
https://scrip.pharmaintelligence.informa.com/SC146770/CEO-Of-Indias-mRNA-Pioneer-Gennova-On-Cancer-Vaccines-VC-Interest
In this episode, I speak to Adam Ricciardone, global head of self-care research and development at Johnson & Johnson Consumer Health. Adam identifies four macro trends the company is observing worldwide: total wellness, sustainability, a focus demographic shifts and the “techceleration” of self-care. International Self Care Day was last weekend on July 24, so Adam walks us through some of J&J’s new self-care technology and explains the importance of R&D in the self-care industry. Finally, while self-care trends are similar around the globe, Adam explains why non-western countries, particularly Asian countries, are quicker to adopt some than western countries are.
Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC146762/Quick-Listen-Scrips-Five-MustKnow-Things
Pink Sheet reporter and editors discuss another project to improve clinical trial diversity in the US, the Patent Trial and Appeal Board director review process, and the FDA promoting its head of controlled substance policy to deputy CDER director.
DCTS: Exploring The Innovative Technologies, Push For Diversity, Cybersecurity, And the Future Of Remote Trials
While diversity is largely recommended by regulators today, it is quickly becoming apparent diversity is vital for successful clinical trials in the future. For sponsors to fulfil the requirements, continual exploration and use of decentralized trials (DCTs) are the obvious solutions. For more information, listen to the podcast with experts from our partner at Clario.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
바이오텍 가치하락, 바이오신약의 특허 만료 등 시장상황의 변화로 글로벌 제약바이오 업계가 새로운 인수합병 파도에 휩쓸릴 수 있다는 Scrip Intelligence 기사를 요약한 내용입니다.
https://scrip.pharmaintelligence.informa.com/SC146589/Are-Market-Conditions-Setting-Up-A-Biopharma-MA-Wave
Articles mentioned in this podcast:
US FDA Has 10 Months To Provide Answer On Perrigo/HRA OTC Oral Contraceptive Application
Allowing States To Ban Abortion Services Increases Calls For Making Birth Control Available OTC
OTC Switch For Daily Oral Contraceptive Brandished In Senate Health Care Policy Duel
Barriers To US OTC Emergency Contraceptive Sales Remain Despite Court Rebuke Of Restrictions
Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process And For Consumers
Dual Rx/OTC Status In US ‘Additional Condition’ Switch Proposal: Necessary Or Questionable?
US FDA May Play Central Role In Assuring Access To Mifepristone Post Roe v. Wade Mifepristone Access Imperiled By Supreme Court’s Draft Decision Overturning Abortion Rights With Roe v. Wade In Rearview, What’s Next For Women’s Health
Telemedicine Among Sticky Wickets As Uncertainty Abounds Post-Roe v. Wade
Period-Tracking Apps Should Safeguard Data, Reassure Customers In Post-Roe Era
Pink Sheet reporters and editors discuss the FDA’s latest COVID-19 vaccine emergency use authorization, activities during the FDA commissioner’s remaining time in office, and patients requesting a gene therapy risk management plan.
In this month’s Digital Health roundup, Medtech Insight’s Barnaby Pickering discusses DeHealth, which developed a platform built on cryptocurrency, and executive interviews with Glooko and Omada Health about their diabetes platforms. Marion Webb will highlight a conversation with Nixon Gwilt Law attorney Bethany Corbin about key steps developers of period-tracking apps can take to ensure that sensitive health data remains safe and private. Reed Miller discusses Braidio’s health information platform and Pyx Health’s hybrid solution for loneliness.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Period-Tracking Apps Should Safeguard Data, Reassurance Customers In Post-Roe Era
Building Digital Platforms To Bridge Diabetes Care Gaps
DeHealth Applies Blockchain To Medical Data Transactions In Bid For Transparency
Pyx Health Is Addressing The Loneliness Crisis With Digital/Human Combination
Minute Insight: Braidio’s My Health Concierge Service Incorporates BlueSemi’s Eyva Health Tracker ‘Gadget’
Pink Sheet reporters and editors discuss new changes to the Senate drug pricing bill, the FDA’s decision to call a second advisory committee meeting for Amylyx’s ALS drug, and Covis’ request to skip a vote during the hearing on Makena’s withdrawal.
欢迎来Citeline中国生物制药热点博客做客！ 分析热点，政策解读和行业热门追踪是我们的宗旨。
在首期的节目中，中国主编杨宏新Brian和资深记者严洁Dexter首先讨论了康方生物最新获得药监局批准，世界首个双特异抗体卡度尼丁单抗Cadonilimab，治疗宫颈癌（China Approves World’s First Bispecific IO Drug Amid PD-1/L1 Glut）。
这个获批也是中国第一个批准治疗宫颈癌的肿瘤免疫治疗。默克的K药比较，这个获批有什么意义？对于其他在研的双特异抗体PD-1来说有什么影响？
接下来的话题是最近国家药监局公布《关于进一步加强外资企业服务工作的通知》，其中特别提出要加快临床急需境外新药，罕见病，儿童用药和重大传染病新药的审评审批（ Invitation Extended: New Chinese Policies Aim To Lure Foreign Pharma Firms） 。此外，亮点还包括：专栏链接制度，畅通企业诉求沟通渠道，作为“稳外资稳外贸”的一环，这些新政策将带来新药获批的加速和监管交流沟通的进一步加强。
Citeline的中国团队还讨论了抗体药物偶连体ADC的竞争格局，以及中国生物Sino Biopharma制药通过旗下InvoX对于纳斯达克上市的英国抗体药企F-Star的1.61亿美元的收购 （Asia Deal Watch: invoX Builds Novel Pipeline Through $161m F-star Acquisition）。这个收购也是2022年中国生物药企的首个亿元级别的大手笔收购。此次收购对于ADC关注的中国药企来说，无疑是一剂强心剂。
如果你有任何建议，意见和希望听到我们讨论的话题，欢迎留言！我们还将不定期邀请特邀嘉宾一起来到博客间，和CIteline中国团队一起深度潜水，聊聊影响深远的生物制药领域的热点和政策话题。
感谢收听，让我们下一期节目见！
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。
今回取り上げた記事はこちら:
China Rush Over? Korean Firms Step Up To Seize Opportunities
（邦題意訳「中国企業ブームに続くか？国際進出を強める韓国企業たち」）
https://scrip.pharmaintelligence.informa.com/SC146600/China-Rush-Over-Korean-Firms-Step-Up-To-Seize-Opportunities
【コンサルティングサービスのご紹介】
ファーマインテリジェンスのコンサルティングチームは、製薬やバイオ技術、医療機器といった分野で活躍する企業のお客様と緊密に連携し、個別の課題をピンポイントで解決します。開発途中の薬剤に関するビジネス機会評価や売上予測、価格予測をはじめ、医療経済評価モデルや臨床試験計画、ベンチマークの策定、協業戦略の策定やポートフォリオの優先順位評価など、幅広いニーズに応え、エビデンスに基づいた意思決定を支援します。今解決したい課題をお持ちの方、ぜひご相談ください。
担当者：今堀 逸太郎（itsutaro.imahori@informa.com）
ImmunoACT CEO Dr Rahul Purwar outlines progress made by the firm’s early-stage CAR-T therapy in India, which he believes can be available at a tenth of the price of current on-market treatments or around the cost range for bone marrow transplant. Laurus Labs, which holds about 27% in ImmunoACT, is expected to help shape the firm’s globalization plans.
https://scrip.pharmaintelligence.informa.com/SC146616/Whats-Next-At-Dr-Reddys-Biologics-CDMO-Cell-And-Gene-Therapy-Push https://scrip.pharmaintelligence.informa.com/SC125979/Early-Indian-Promise-For-A-Cut-Price-CAR-T-Therapy https://scrip.pharmaintelligence.informa.com/SC125879/Gene-And-Cell-Therapies-In-Asia-Indian-Environment-Evolving-But-Multiple-Issues-Unresolved https://scrip.pharmaintelligence.informa.com/SC144368/Dr-Reddys-Pilots-Sputnik-V-Soft-Launch-In-India-Explores-CART-Space
On this episode, HBW speaks to Victoria Nichols, project director of Free the Pill. Operated by Ibis Reproductive Health, a nonprofit advocacy organization focused on advancing sexual and reproductive autonomy worldwide, Free the Pill is a campaign supporting increased oral contraceptive access through OTC birth control pills. Ibis Reproductive is also working with Perrigo to submit an Rx-to-OTC switch NDA later this year for its progestin daily oral contraceptive. In the wake of the Supreme Court’s decision to overturn Roe v. Wade on June 24, Nichols talks about the importance of advocating for OTC birth control, the limited availability of OTC oral contraceptives in the US, and the current legislation being introduced that would help ensure OTC birth control is covered by insurance.
Medtech Monthly is here! Check out the first episode of our new podcast series: It's a knock-down (not really), drag-out (not really), freewheelin' (very much so) conversation about quality versus compliance, with the US FDA's Cisco Vicenty in one corner, and former FDA compliance chief Steve Silverman in the other. Medtech Insight articles addressing topics discussed in this episode: • Speaking Of Medtech, Ep. 9: The Case For Compliance • Speaking Of Medtech, Ep. 8: Medical Device Quality • Opinion: The Case For Quality – AND Compliance • Quality Control & Compliance
Datamonitor Healthcare’s oncology team discuss key results from ASCO 2022
Supporting links: post-ASCO report https://service.datamonitorhealthcare.com/hkc/thought-leadership/article239222.ece?sg=article
Other platforms in addition to SoundCloud:
Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836
Google Podcasts – https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz
TuneIn – https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/
Spotify Podcasts – https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
In this episode of Report Digest, reporter Barnaby Pickering speaks to analyst Mike Carmody about Meddevicetracker’s recent report on deep brain and Vagus nerve stimulation. The two discuss market players, recent tech developments and future potential for the market.
Scrip Intelligence에 실린 파이낸스 워치 (Finance Watch)기사의 요약 내용으로 글로벌 제약바이오업계가 올해 들어 현금 비중을 늘리고 인력 감축에 나서고 있으며, 올해 1분기 글로벌 시장에서 전체 제약바이오 투자 규모는 줄었지만 벤쳐캐피탈 (VC)의 제약바이오 투자 비중이 압도적으로 증가했다는 내용입니다.
https://scrip.pharmaintelligence.informa.com/SC146403/Finance-Watch-More-Job-Cuts-As-Companies-Prioritize-Cash-Conservation https://scrip.pharmaintelligence.informa.com/SC146493/Finance-Watch-Venture-Capital-Dominates-Biopharma-Funding-So-Far-In-2022
In this month’s Digital Health roundup, Medtech Insight’s Marion Webb discusses her deep-dive article on menopause with leading experts in this rising industry and Barnaby Pickering highlights UK-based Proximie, which developed a web-based platform that allows surgeons and other clinical experts to collaborate virtually in the operating suite. The company recently raised $80m in a series C round.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Hot Flash! Menopause May Not Be Sexy, But Investors Are Warming Up To Digital Health Solutions Digital Operating Theater Company Proximie Garners $80M In SoftBank-Jobs Raise
世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。
For listeners in the pharma industry, we deliver a summarized insight from Scrip and Pink Sheet in Japanese, one story at a time.
今回取り上げた記事はこちら The article for this episode is:
US FDA’s ‘Mature’ Approach To Quality: ‘Encourage More, Punish Less’ （邦題意訳「FDA、薬の品質対策に新戦略 “ムチよりアメ”のQMM制度とは？」）
https://pink.pharmaintelligence.informa.com/PS146314/US-FDAs-Mature-Approach-To-Quality-Encourage-More-Punish-Less
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担当者：今堀 逸太郎（itsutaro.imahori@informa.com）
Join Brian Yang in this wide-ranging interview with top executives from Jiangsu Hengrui’s US subsidiary Luzsana, on topics ranging from innovation to going global, US approvals of China-made drugs and China’s regulatory harmonization efforts.
In this episode, I speak to Annika Greve from Loop and Terracycle about the work that those companies do reducing waste across industries. Loop works with companies like Bausch+Lomb to create packaging that can be bought, used, and then dropped off in big box stores where consumers regularly shop. We spoke about how greenwashing from companies can harm consumer trust in the industry, and how the relatively recent habit of disposability will ultimately drive how companies switch to sustainable practices.
In this edition of Device Week, Medtech Insight’s Barnaby Pickering discusses recent developments in the highly competitive continuous glucose monitoring space and editor Marion Webb explains the application of robotics to common blood sampling.
The archive of Medtech Insight's Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, and Spotify Podcasts: https://medtech.pharmaintelligence.informa.com/podcasts
Medtech Insight articles addressing topics discussed in this episode:
Dexcom Kiboshes Insulet Merger Rumors: https://medtech.pharmaintelligence.informa.com/MT145464/Dexcom-Kiboshes-Insulet-Merger-Rumors
FDA Clears Abbott’s Libre 3: https://medtech.pharmaintelligence.informa.com/MT145463/FDA-Clears-Abbotts-Libre-3
Medtronic Starts Planned Portfolio Simplification With DaVita Renal Care Spin Off: https://medtech.pharmaintelligence.informa.com/MT145461/Medtronic-Starts-Planned-Portfolio-Simplification-With-DaVita-Renal-Care-Spin-Off
Dexcom Rumored To Be In Talks To Acquire Insulet: https://medtech.pharmaintelligence.informa.com/MT145442/Dexcom-Rumored-To-Be-In-Talks-To-Acquire-Insulet
Vitestro Introduces First Autonomous Phlebotomist Robot In Europe https://medtech.pharmaintelligence.informa.com/MT145467/Vitestro-Introduces-First-Autonomous-Phlebotomist-Robot-In-Europe
Microbot Medical Hopes To Bring First Disposable Endovascular Robot To US Market: https://medtech.pharmaintelligence.informa.com/MT145377/Microbot-Medical-Hopes-To-Bring-First-Disposable-Endovascular-Robot-To-US-Market
Speaking Of Medtech, Ep. 9: The Case For Compliance In this episode of Speaking Of Medtech: Over the past decade or so the US FDA and many device makers have been advocating for quality over compliance, but what if promoting compliance was seen as a good goal for the medtech industry? Medtech Insight articles addressing topics discussed in this episode: • Opinion: The Case For Quality – AND Compliance https://medtech.pharmaintelligence.informa.com/MT145406/Opinion-The-Case-For-Quality--AND-Compliance
• Quality Control & Compliance https://medtech.pharmaintelligence.informa.com/policy-regulation/quality-control
Title: Korean-language Scrip article summary 보스턴으로 몰리는 한국 제약바이오업계의 기회와 도전 (Korean Biopharmas Rush To Boston: What Are The Challenges And Opportunities?)
Description: 최근 국내 제약바이오사들의 미국 진출이 더욱 활발해지고 있는 이유와 이 기업들이 미국에 진출할 때 특히 어떤 어려움을 겪고 있는 지에 대한 Scrip Intelligence의 인터뷰 기사를 요약한 내용입니다. https://scrip.pharmaintelligence.informa.com/SC146422/Korean-Biopharmas-Rush-To-Boston-What-Are-The-Challenges-And-Opportunities
Ellie Davenport, Summer Colling, and Kripa Krishnan discuss the psychiatric disorder market and outlook, with a focus on schizophrenia, bipolar, and major depressive disorder.
Schizophrenia disease analysis report and forecast
https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/psychiatry/schizophrenia/disease-analysis/article216769.ece
Bipolar disease analysis report and forecast
https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/psychiatry/bipolar-disorder/disease-analysis/article219685.ece
Major depressive disorder disease analysis report and forecast
https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/psychiatry/depression/disease-analysis/article220083.ece
Other platforms:
Apple Podcasts - podcasts.apple.com/us/podcast/phar…sts/id923189836 Google Podcasts - podcasts.google.com/feed/aHR0cHM6Ly…C9zb3VuZHMucnNz TuneIn - tunein.com/podcasts/Business--…-Podcasts-p1140128/ Spotify Podcasts - open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Reporters and editors from the Pink Sheet and sister publications covering the medical device and health, beauty and wellness sectors look at Califf’s goals, accomplishments and trials during the early days of his second term.
Japanese-language summary insights from Scrip and Pink Sheet, a selected story at a time. 世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。
The article for this episode is: 今回取り上げた記事はこちら
Is It Tougher To Conduct Decentralized Trials In The EU? ‘Don’t Fall Prey To Negative Narrative’ 邦題意訳「EU圏ではDCTがやりにくい？ ネガティブな思い込みの盲点」 https://pink.pharmaintelligence.informa.com/PS146158/Is-It-Tougher-To-Conduct-Decentralized-Trials-In-The-EU-Dont-Fall-Prey-To-Negative-Narrative
In this episode, HBW speaks to Barbara Kochanowski and David Spangler from the Consumer Healthcare Products Association about OTC monograph reform. The old OTC monograph system was reimagined as a part of the 2020 CARES act passed in the early stages of the pandemic. Designed to streamline and modernize the OTC monograph system, the results have been slow as the FDA has had most of its attention on the pandemic. However, as the agency hires more staff, Spangler says that we should expect to see a ‘faster moving FDA’ in the next three years. Spangler and Kochanowski also talk about the efficacy of the reforms and how they have helped educate their members about the changes.
EU MedTech Forum 2022: Regulatory Predictability Impacts Renewed Calls For Devices Agency by Informa
Ausbiotech’s CEO and the Senior Trade and Investment Commissioner at the Australian Embassy in South Korea talk to Scrip’s Jung Won Shin on the sidelines of Bio Korea 2022 about what makes Australia an attractive clinical trial destination for Korean and other foreign firms, as well as collaborations and other opportunities between the two countries.
In this month’s podcast, Medtech Insight's Reed Miller discusses iRhythm’s CEO Quentin Blackford’s vision for the company as it plans for expanding its remote cardiac monitoring and arrythmia diagnostics market. Marion Webb highlights conversations with ORCHA’s clinical lead Fatima Ahmed on the shortfall of trustworthy femtech apps and with medical robotic authority Moshe Shoham on the future of robotics. Barnaby Pickering introduces SpectralMD’s developed AI-augmented imaging system and NHS’ recently published readout of the OCTAPUS AI study.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Don’t Trust That (Femtech) App – Most Health Apps Don’t Meet ORCHA’s Data Privacy, Assurance Standards SpectralMD Has Developed A Breakthrough Tool For Wound Healing Minute Insight: NHS Employs OCTAPUS AI To Predict Lung Cancer Recurrence Exec Chat: As Reimbursement Questions Get Answers, iRhythm Looks To The Future Exec Chat: Israel’s Authority On Medical Robotics Lifts Curtain Behind Technion’s Success Stories
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.
Sanjiv Navangul, managing director and CEO, Bharat Serums and Vaccines, outlines, in a wide ranging interview, the firm’s gameplan to establish itself as a “force to reckon with” in women’s health - it goes beyond drugs and encompasses devices and potentially digital therapeutics as well. The former Janssen India chief also weighs in on the worrying industry-wide input cost escalation scenario and supply chain turbulence.
Report Digest: Discussing What's Going On With Prostate Cancer Diagnosis And Treatment by Informa
Pink Sheet reporter and editors and HBW Insight editor discuss FDA reforms in the new user fee reauthorization bill, additional industry inducements to market OTC naloxone, and the impact of a Supreme Court’s potential overturning of Roe v. Wade on the agency.
In this episode, HBW Insight speaks to Michael Hufford, co-founder and CEO of Harm Reduction Therapeutics about the inaccessibility of naloxone, a life-saving opioid overdose antidote. Hufford unpacks on the history of naloxone access and explains why standing orders aren’t as helpful as they seem. We also explore the incentives for companies currently producing prescription naloxone to make the switch to OTC status—and why many of them have chosen not to. While the financial incentive may not be there, the public health need is dire, and Hufford explains the importance of Harm Reduction Groups and non-profit pharmaceutical companies for getting naloxone into the hands of those who need it the most.
In this episode, HBW Insight chats with IQVIA Consumer Health’s Prisana Pitale about research the organisation has done on the recent self-care trends that will endure after COVID. Commissioning an external organisation to speak to industry leaders, Pitale points to wellness and prevention, Rx-to-OTC switch and naturals as drivers of long-term change in global consumer health markets. We also dig a bit deeper into sustainability and artificial intelligence, which we agree are important disruptors that OTC companies need to act on if they are stay ahead of the pack in the years ahead.
Pink Sheet reporter and editor discuss next steps in the development of COVID-19 vaccines for young children, complaints about CMS’s coverage decision for Aduhelm, and the congressional investigation of McKinsey’s FDA conflicts of interest.
The EU HTA Regulation: How It Threatens Device Launches And Where The Solutions Lie by Informa
The CEO of Chinese biotech CANbridge talks to Scrip’s Brian Yang on a broad range of topics related to the company’s plans and strategy in this new series of audio interviews with senior biopharma executives in China.
In this episode, HBW speaks to AI technology expert Sampo Parkkinen, CEO of Revieve. We discuss the importance of customization for businesses and consumers, the future of AI in the cosmetics industry, and the younger demographics that are most interested in brand personalization. Finally, we talk about Revieve’s space in the metaverse, and how businesses can leverage new technology to build relationships with their consumers.
Pink Sheet reporter and editors discuss CDC advisors’ views on COVID-19 vaccine booster policy, new FDA guidance to promote clinical trial diversity, and what some FDA employees are finding when they return to the White Oak headquarters.
Zydus Lifesciences’ (formerly Cadila Healthcare) managing director Sharvil Patel speaks to Scrip on a host of topics ranging from a focus on rare diseases to a fresh corporate identity and plans for launch of a two-dose version of the world’s first plasmid DNA vaccine that it developed against COVID-19. Patel also talks about his personal business journey as well as the importance of building organizational agility to deal with uncertainty that companies are increasingly having to deal with.
In this episode, HBW Insight editors look ahead to Q1 sales and earnings reports of the world’s largest consumer healthcare companies. We reflect on what has happened in the last 12 months during the COVID-19 pandemic, and what the next few months might bring for industry. The return of cough and cold, inflation and the war in Ukraine and OTC business spin outs are all major trends shaping the market right now.
In this edition of Device Week, Medtech Insight’s Marion Webb reviews her recent interviews with Martha Shadan, the CEO of Miach Orthopedics, and Outset Medical’s CEO Leslie Trigg. Reed Miller has an update on Medtronic’s long-awaited renal denervation technology.
Listen to the podcast via the player below: The archive of Medtech Insight's Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, and Spotify Podcasts. Medtech Insight articles addressing topics discussed in this episode: Exec Chat: Outset Medical CEO Shares Lessons Learned On Road To Transforming Kidney Care
Exec Chat: Miach Orthopedics Bullish On BEAR For Repairing, Not Replacing, Torn ACLs AAOS 2022 Roundup: 3D Printing, Digital Tech In Surgery, Fixation Technologies, Curved Implants AAOS 2022 Roundup: Stryker, Zimmer Biomet, J&J’s DePuy Synthes, Canary Medical Cardiovascular Catch-Up: ACC Brings Encouraging Renal Denervation And TAVR Data For Medtronic
Cardiovascular Catch-Up: Philips New AI Finds AF Needle In ECG Haystack; LimFlow Moves Closer To US Approval
In this month’s podcast, Medtech Insight's Reed Miller reports on Amazon’s new deal with North Carolina-Triangle company Thread Research to create decentralized clinical trials and HIMSS coverage. Marion Webb discusses highlights from her live coverage at the AAOS and Sensors Summit conferences.
Medtech Insight articles addressing topics discussed in this episode:
Silicon Valley Bank Advisor Predicts 2022 Will Be Year For Healtech, Massive Consolidation https://medtech.pharmaintelligence.informa.com/MT145169/Silicon-Valley-Bank-Advisor-Predicts-2022-Will-Be-Year-For-Healthtech-Massive-Consolidation
AAOS 2022 Roundup: Stryker, Zimmer Biomet, J&J’s DePuy Synthes, Canary Medical https://medtech.pharmaintelligence.informa.com/MT145242/AAOS-2022-Roundup-Stryker-Zimmer-Biomet-JJs-DePuy-Synthes-Canary-Medical
AAOS 2022 Roundup: 3D Printing, Digital Tech In Surgery, Fixation Technologies, Curved Implants https://medtech.pharmaintelligence.informa.com/MT145251/AAOS-2022-Roundup-3D-Printing-Digital-Tech-In-Surgery-Fixation-Technologies-Curved-Implants
Amazon Partners With Thread To Help Decentralize Clinical Trials
In this episode, HBW Insight takes a bird’s eye view of sustainability in the cosmetics industry with HBW Insight Executive Editor Ryan Nelson. We discuss the drivers of sustainability efforts such as consumer demand for more eco-friendly products and the growing social consciousness about climate. We also discuss what steps companies are taking to make their products more sustainable, how the beauty industry is using third party regulatory groups to combat greenwashing, as well as the legislation in the US and UK that is putting pressure on businesses.
In this episode of Device Week: US lawmakers grilled FDA device center director Jeff Shuren on 30 March about the agency’s approach to putting together the latest user-fee agreement between industry and FDA. Medtech Insight articles addressing topics discussed in this episode: • FDA’s Shuren Grilled About Handling Of MDUFA V At House Hearing • Lifting The Hood On MDUFA V
Pink Sheet reporter and editors discuss lessons from the FDA’s advisory committee on Amylyx’s ALS drug, the FDA’s proposed FY 2023 budget surge, and the ongoing effort to change the CMS coverage decision on Aduhelm.
In this episode, HBW Insight catches up with Association of the European Self-Care Industry, AESGP, director general Jurate Švarcaite to chat about the association’s upcoming Annual Meeting. The 58th Annual Meeting will be the first since the coronavirus pandemic that will take place in person, at the Hotel Meliá Castilla in Madrid, Spain, from the 7th to the 8th June. Bringing together more than 300 delegates from the consumer health industry, partner organisations and policymakers, topics will include self-care market trends, regulatory innovations seen during the pandemic, sustainability and advertising. There will also be plenty of time for networking between sessions and at the opening evening, something that has been sorely missed and is a key highlight of the AESGP Annual Meetings.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
Pink Sheet reporter and editors discuss a grassroots campaign against coverage of a controversial Alzheimer’s treatment, the potential for drug pricing reform, and the pandemic effects on FDA hiring and retention.
In this episode of Speaking Of Medtech: Too often quality is overshadowed by regulatory and compliance, and some manufacturers view quality as an obstacle to getting product into the marketplace rather than a concept that will help a company save money, reputation, and patient lives. Medtech Insight articles addressing topics discussed in this episode: • Quality Control & Compliance
Post-market surveillance requirements apply to all products under the Medical Device Regulation. But it is not just about compliance. Companies would do well to evaluate the additional benefits added PMS efforts can offer them, leading devices expert Bassil Akra explained during a recent interview with Medtech Insight. And he explained how small companies can be equally competent at PMS as large companies.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
Welcome to Pharmaprojects’ 2022 review of trends in pharmaceutical R&D.
For 30 years now, we’ve been taking an annual look at the evolution of pharma R&D, and in this audiobook, we examine the state of play at the start of 2022.
In this episode, HBW Insight speaks to self-care marketing expert Stuart Mayell about the hottest trends in UK consumer health. Based on interviews with a variety of consumer health clients, Mayell – who is Head of Creative Difference at the Difference Collective – confirms many of the trends seen elsewhere, such as a need for health literacy as consumers move online and an emphasis on wellness and prevention. But what is perhaps new is the way this focus on prevention is pushing consumers, especially within younger generations, away from individualism and towards pro-social choices. Pressures on income from inflation, war and climate change are also shaping consumer choices, he thinks. Consumer health brands must find their purpose, he advises, if they are to stand out from the crowded shelf and compete with cheaper, generic options.
Pink Sheet reporter and editors discuss new accelerated approval legislation, the changing FDA patient-focused drug development initiative, and the importance of access for COVID-19 treatments.
In this edition of Device Week, Medtech Insight’s Reed Miller chats with UK-based reporter Barnaby Pickering about Zimmer Biomet’s recent spin-off of its spinal and dental businesses under the name ZimVie, and Marion Webb explains the emerging field of femtech, which includes innovations to treat often-overlooked needs in women’s health.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Zimmer Biomet Spin-Off’s Share Price Plummets https://medtech.pharmaintelligence.informa.com/MT145159/Zimmer-Biomet-Spin-Offs-Share-Price-Plummets
‘Femtech’ Evolving Beyond Periods, Pregnancy And Postpartum: What’s Next In $1.2Tr Women’s Health https://medtech.pharmaintelligence.informa.com/MT145121/Femtech-Evolving-Beyond-Periods-Pregnancy-And-Postpartum-Whats-Next-In-12Tr-Womens-Health
For MedTech Europe’s Patrick Boisseau, the newly launched Innovative Health Initiative is a real “game changer.” In this interview, he explains how companies should get involved in cross-sectoral medtech/pharma projects that will revolutionize European healthcare innovation.
Davinderpreet Mangat, Ellie Davenport, and Millie Gray provide a thought leadership piece on PARP inhibitors in various oncology markets.
Supporting links:
Breast cancer - https://service.datamonitorhealthcare.com/disease/oncology/gynecological-cancer/breast-cancer-hr-her2/disease-analysis/article212246.ece https://service.datamonitorhealthcare.com/disease/oncology/gynecological-cancer/breast-cancer-triple-negative/disease-analysis/article210516.ece Ovarian cancer - https://service.datamonitorhealthcare.com/disease/oncology/gynecological-cancer/ovarian-cancer/disease-analysis/article215125.ece Pancreatic cancer - https://service.datamonitorhealthcare.com/disease/oncology/gastrointestinal-cancer/pancreatic-cancer/market-spotlight/article200459.ece Prostate cancer - https://service.datamonitorhealthcare.com/disease/oncology/urological-cancer/prostate-cancer/disease-analysis/article223558.ece Other platforms: Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
In this episode, HBW Insight talks probiotics with David Pineda Ereño, founder of DPE International Consulting and consultant to the International Probiotics Association. Since 2006, no health claims for probiotics have been allowed by harmonised European Union regulations. Even the term probiotics is considered an unauthorised health claim by the European Commission. However, as David explains, many EU member states, including Italy and Spain, are starting to go their own way, adopting a more liberal approach to this booming wellness market. We discuss what the future of EU probiotics regulation may hold, as well as some of the exciting science that is coming out all the time, pointing to the health benefits of this extremely popular ingredient.
Pink Sheet reporters and editors discuss changes to the standard for some COVID-19 treatment emergency use authorizations, late-coming COVID-19 vaccines and their potential effect on the market, and an upcoming HHS biosimilar use and cost study.
In this edition of Device Week, Medtech Insight’s Reed Miller chats with UK-based reporter Barnaby Pickering about Abbott’s recent supplementary premarket submission to its CardioMEMS platform, recent safety data for Dexcom’s G7 continuous glucose monitor, and where KPMG expects life sciences investment to be focused in 2022. Medtech Insight articles addressing topics discussed in this episode:
-Abbott Hopes To Prevent Heart Failure Hospitalizations With New CardioMEMS HF Labeling - https://medtech.pharmaintelligence.informa.com/MT145103/Abbott-Hopes-To-Prevent-Heart-Failure-Hospitalizations-With-New-CardioMEMS-HF-Labeling -KPMG Speaks On What 2022 Medtech Investment May Look Like -Dexcom Shows Off More G7 Data - https://medtech.pharmaintelligence.informa.com/MT145078/KPMG-Speaks-On-What-2022-Medtech-Investment-May-Look-Like
US-based biotech Lactocore Group’s CEO and co-founder Anton Malyshev talks to Scrip on milk-derived, novel peptides that hold potential as safe and effective treatments for a range of common psychiatric, metabolic and cognitive disorders.
Lead asset LCGA-17 with indications for mental health conditions, like anxiety and post-traumatic stress disorder, is at the pre-Investigational New Drug stage and could have the unique advantage of intranasal administration. Another asset can regulate appetite, with potential to treat obesity and type-2 diabetes and a third could find use as adjunct or complimentary therapy for Parkinson’s disease.
In this month’s podcast, Medtech Insight's Reed Miller reports on IBM Watson Health’s divestiture, Barnaby Pickering discusses his Exec Chat with Bloom Diagnostics, autonomous robots and Philips’ ultrasound game. Al-Faruque (Danny) Ferdous highlights the latest digital health regulatory news.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Exec Chat: Bloom Diagnostics’ Chair Discusses The Future Of At-Home Lateral Flow Testing
Philips Steps Up Ultrasound Game With Lumify 4.0
Minute Insight: Can Robots Do Surgery Without Human Help?
IBM Divests Watson Health Assets To Focus On Cloud And AI Businesses
Experts: New Cybersecurity Standard Goes Beyond What US And Other Regulators Require
FDA Continues To Down-Classify Digital Health Apps With New Cardio App Rule
Pink Sheet reporters and editors consider Robert Califf’s priorities now that he is FDA commissioner, what sponsors can learn from the sintilimab advisory committee meeting, and the latest generics news from a major (and in-person) trade association conference.
In this episode of Speaking Of Medtech we’re talking real-world evidence and real-world data – what it is, who’s using it, and why the medtech industry and the US FDA are so keen to collect it.
Medtech Insight articles addressing topics discussed in this episode:
AdvaMed Asks US FDA To Add Causality, RWE To Safety-Reporting Draft Guidance (https://medtech.pharmaintelligence.informa.com/MT144840/AdvaMed-Asks-US-FDA-To-Add-Causality-RWE-To-SafetyReporting-Draft-Guidance) Real-World Evidence Deemed Essential For Breakthrough Designations (https://medtech.pharmaintelligence.informa.com/MT144525/Real-World-Evidence-Deemed-Essential-For-Breakthrough-Designations) FDA Doc Bemoans ‘Dearth’ Of Pediatric Devices, Says Real-World Data Could ‘Make A Difference’ (https://medtech.pharmaintelligence.informa.com/MT144492/FDA-Doc-Bemoans-Dearth-Of-Pediatric-Devices-Says-RealWorld-Data-Could-Make-A-Difference) Woodcock: Use Of Real-World Evidence Still Brings ‘A Lot Of Problems’ (https://medtech.pharmaintelligence.informa.com/MT144008/Woodcock-Use-Of-Real-World-Evidence-Still-Brings-A-Lot-Of-Problems)
When the White House Office of Management and Budget, or OMB, sent the US FDA’s draft harmonized Quality System Regulation back to the agency after only 35 days of review, it raised some eyebrows in industry. Check out what experts are saying about the reg review time frame in this week’s podcast. Medtech Insight articles addressing topics discussed in this episode: • Too Slow, Too Fast, Or Just Right? Experts Weigh In On OMB’s 35-Day Review Of FDA’s Draft QSR • OMB Completes Review Of FDA’s Draft Harmonized Quality System Regulation • At Long Last, FDA Sends Draft Harmonized Quality System Regulation To OMB For Review
In this episode, HBW Insight catches up with cannabis expert Stephen Oliver to talk about the current state of play in Europe’s cannabidiol markets. Co-founder of the Canna Consultants, Oliver predicts that, after a long waiting period, we may be about to see some movement from UK and EU regulators. However, while the European Commission moves closer to finding a route to CBD regulation, especially with synthetic and isolate CBD food products, the UK Food Standards Agency might find itself on the wrong end of legal actions from manufacturers and suppliers that feel disadvantaged by the country’s approach, he thinks.
The US Food and Drug Administration and the medtech industry failed to come to terms on a user fee package by the January 15 deadline. But conversations have resumed, and some say we might see a final deal in the near future. Senior reporter Danny Al-Faruque has the scoop.
On this week’s podcast, Medtech Insight's Marion Webb reviews the recent Digital Healthcare Innovation Summit and Barnaby Pickering provides an update on a major milestone for autonomous surgical robots.
Medtech Insight articles addressing topics discussed in this episode:
https://medtech.pharmaintelligence.informa.com/MT145031/Minute-Insight-Can-Robots-Do-Surgery-Without-Human-Help
Pink Sheet reporters and editors discuss the EUA request for Pfizer’s COVID-19 vaccine in children younger than 5, the full approval of Moderna’s COVID-19 vaccine, states ignoring FDA treatment and vaccine recommendations, and Zohydro ER’s withdrawal in the US.
In this episode, HBW Insight's David Ridley chats with Nestle Health Science's Anna Mohl about the firm's new podcast, Nutrition Unlocked, and about how podcasts are a good way to communicate the science behind nutritional products like dietary supplements. Anna also talks about how some of the biggest COVID-19 trends are driving growth in Nestle's Health Science division – which celebrates its 10th anniversary this year – and why it’s a good time to be in the consumer health business.
In this week’s podcast, senior reporter Brian Bossetta discusses two recent operations that show the promise genetically modified pig organs may hold for patients in need of new organs.
Pink Sheet reporters and editors discuss whether a new report on generic drug prices will affect efforts to green-light government price negotiations, Eli Lilly’s untitled letter for promotion on Instagram, and Oncopeptides deciding to withdraw its accelerated approval withdrawal.
In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, and Barnaby Pickering provide a recap of our digital health coverage from December and January, including Exec Chats with the CEOs of iRhythm and Cognetivity, discuss the potential of digital therapeutics for better health, including a company profile on Akili Interactive, and highlight innovative companies working on brain and neuro functions.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
‘Training People To Be Healthier’: Digital Therapeutics Programmed For Growth
Kids, Time To Play Your Medicine: Akili Prepares Launch Of EndeavorRx Video Game For ADHD
CES 2022: Abbott CEO Robert Ford Announces New Biowearables Line For Consumers, Paving the Way From Measuring Glucose To Ketone, Lactate, Alcohol
Minute Insight: Agendia Collaborates With Illumina And Brazilian Health Care Providers
Money And Materials Will Allow Medtech To Restore Lost Neuro Functions
Stryker Invests Big In Connected Health Care With $3.09Bn Acquisition Of Vocera
Renalytix Collaborates With ADA To Improve Early Detection Of Kidney Disease
Exec Chat: Cognetivity’s Simple Brain Test Could Unlock Trillions In Health Care Savings
Exec Chat: New iRhythm CEO Foresees Enormous Opportunity In AI For Arrhythmia Detection
On this week’s podcast, Medtech Insight's Reed Miller, Marion Webb and Barnaby Pickering provide a recap of our J.P. Morgan Health Care conference coverage including Abbott, Dexcom, Zimmer Biomet and Nuvasive and spotlight Scottish company PneumoWave.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
https://medtech.pharmaintelligence.informa.com/MT144959/Start-up-Spotlight-PneumoWave-Hopes-Sensor-Tech-Can-Prevent-Opioid-Deaths
https://medtech.pharmaintelligence.informa.com/MT144948/JPM-2022-Abiomed-Penumbra-Renalityx
https://medtech.pharmaintelligence.informa.com/MT144941/JPM-2022-Boston-Scientific-Inspire-Nuvasive-Vericel
https://medtech.pharmaintelligence.informa.com/MT144939/JPM-2022-MidWeek-IVD-Roundup-Guardant-Illumina-Ortho-Clinical-Thermo-Fisher
https://medtech.pharmaintelligence.informa.com/MT144935/JPM-2022-Abbott-iRhythm-Novocure-Zimmer-Biomet
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Pink Sheet reporters and editors discuss how the hearings for the withdrawal of Avastin’s accelerated approval in breast cancer could inform the same process for Makena, Robert Califf’s view that public trust in the agency will be rebuilt, and a request to increase the dispensing fees associated with COVID-19 treatments Paxlovid and molnupiravir.
For more details see https://pharmaintelligence.informa.com/events/awards/japan-awards-2022 (English) or https://pharmaintelligence.informa.com/ja-jp/events/awards/japan-awards-2022 (Japanese)
In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover. Medtech Insight article addressing topics discussed in this episode: • Happy New Year! (I Think?): Some 2022 Predictions For FDA’s Device Center - https://medtech.pharmaintelligence.informa.com/MT144897/Happy-New-Year-I-Think-Some-2022-Predictions-For-FDAs-Device-Center
In this first edition of “Report Digest,” UK-based reporter Barnaby Pickering discusses the liquid biopsy for oncology market with analyst, Phil Greenfield. The two discuss the main market drivers, and exactly what experts think will occur in the sector in future years.
For more information, take a look at Meddevicetracker’s report, here - https://www.meddevicetracker.com/ReportDetail.cfm?ReportID=477
On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices. Medtech Insight articles addressing topics discussed in this episode: • Right To Repair Proponents Gearing Up To Fight In State Legislatures Again
Pink Sheet reporter and editors discuss the CMS coverage decision for Biogen and Eisai’s Alzheimer’s treatment Aduhelm, the FDA conducting fewer advisory committee meetings in 2021 and the Defense Department’s efforts to increase domestic drug production.
In this episode, HBW Insight speaks to director general of the Association of the European Self-Care Industry (AESGP) and board member of the Global Self-Care Federation, Jurate Švarcaite. As a member of the GSCF board, Jurate has been involved in the creation of the association’s recently launched Charter for Environmentally Sustainable Self-Care, which it describes as the “first industry-wide climate action resolution issued by the consumer health sector.” Jurate tells us all about the story behind the charter and what it aims to achieve, as well as some of the challenges companies face in formulating ambitious, yet concrete and achievable climate action goals.
In the first Device Week podcast of 2022, Medtech Insight editor Marion Webb reviews the medtech highlights from CES, the world’s biggest technology convention.
Listen to the podcast via the player below:
The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider.
Medtech Insight articles addressing topics discussed in this episode: CES 2022: Abbott CEO Robert Ford Announces New Biowearables Line For Consumers, Paving The Way From Measuring Glucose To Ketone, Lactate, Alcohol
CES 2022: Defying Omicron, World’s Biggest Tech Show Goes Live In Las Vegas
Beyond Diabetes: Abbott Launches Glucose Sport Biosensor For Athletes To Track Blood Sugar
Davinderpreet Mangat discusses the forecast for the RSV market. Supporting links: RSV forecast https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/vaccines/respiratory-syncytial-virus-prevention/forecast/article133448.ece RSV disease analysis report https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/vaccines/respiratory-syncytial-virus-prevention/disease-analysis/article220186.ece
Other platforms:
Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Podcast description Davinderpreet Mangat, Pamela Spicer, and Kevin Grogan discuss the skin disease landscape (atopic dermatitis and psoriasis). Topics covered include: • Atopic Dermatitis - 01:00 • Psoriasis – 25:00 Supporting links: • Datamonitor’s Atopic dermatitis disease analysis report - https://service.datamonitorhealthcare.com/hkc/disease/immunology-and-inflammation/dermatology/atopic-dermatitis/disease-analysis/article232260.ece • Datamonitor’s Psoriasis disease analysis report - https://service.datamonitorhealthcare.com/hkc/disease/immunology-and-inflammation/dermatology/psoriasis/disease-analysis/article211531.ece Other platforms: Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
Ocugen’s founder and CEO Shankar Musunuri speaks to Scrip about his company’s mutation-agnostic gene therapy candidate OCU-400, a commercial agreement with CanSino Biologics and plans for a bridging study of partner Bharat Biotech’s COVID-19 vaccine Covaxin post a US FDA clinical hold.
How can self-care companies operating in the UK avoid 'greenwashing' when making environmental claims for their OTC brands? In this episode, HBW Insight's David Ridley speaks to PHD Marketing managing director Jo Stephenson about the new UK Green Claims Code, and how OTC firms can navigate this new guidance on making claims for 'eco-friendly' products. We also chat about the wider implications of sustainability for the consumer healthcare industry, with advice for companies small and large for how to begin to take strategic action against climate change in 2022.
Pink Sheet reporters and editors discuss US FDA commissioner nominee Robert Califf’s Senate confirmation hearing, new COVID-19 vaccine recommendations from the US CDC, and issues related to US approval of China-developed cancer drugs.
On this week’s podcast: Robert Califf goes through his first round nomination hearing in the US Senate, Medtronic and BrainsGate hits their own snags, and the US FDA defines counterfeit products under its new authorities.
In this special podcast, Medtech Insight commercial/R&D editor Reed Miller talks to In Vivo executive editor Ashley Yeo about the annual MTI 100 list and the major trends facing the top medtech companies entering the third year of the pandemic.
Related articles: https://medtech.pharmaintelligence.informa.com/datasets/company-rankings-2022 https://medtech.pharmaintelligence.informa.com/MT144758/MTI-100-Review-Medtechs-Drive-To-Keep-The-Status-Quo-In-A-Year-Like-No-Other https://medtech.pharmaintelligence.informa.com/MT144772/MTI-2022-Outlook-The-PostCOVID-Mantra-For-Medtechs-Prioritize-Optimize-And-Modernize https://medtech.pharmaintelligence.informa.com/MT144780/MTI-100-2022-Big-Cardio-Medtechs-Are-Moving-ESG-Agenda-To-Center-Stage
In this edition of Device Week, Medtech Insight’s Marion Webb talks to UK-based reporter Barnaby Pickering about Cognetivity’s FDA approved diagnostic tool for Alzheimer’s. The company hopes that by providing earlier diagnosis, cost savings in the trillions of dollars can be made. Reed Miller also discusses Boston Scientific’s new “Modular” cardiac rhythm management system. They launched the trial of their Modular system that includes both a subcutaneous ICD and a leadless pacemaker, with positive results expected.
Medtech Insight articles addressing topics discussed in this episode:
- Exec Chat: Cognetivity’s Simple Brain Test Could Unlock Trillions In Health Care Savings
- Boston Scientific Advances First ‘Modular’ Cardiac Rhythm Management System
In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, Ferdous (Danny) Al-Faruque and Barnaby Pickering provide a recap of our digital health coverage in November including interviews with Medtronic, Abbott and Congenica, partnerships and launches, and AI and cybersecurity announcements.
Medtech Insight articles addressing topics discussed in this episode:
Congenica Tries To Bring Clarity To Personalized Medicine For Rare Diseases https://medtech.pharmaintelligence.informa.com/MT144723/Congenica-Tries-To-Bring-Clarity-To-Personalized-Medicine-For-Rare-Diseases
Abbott Focuses On Improving Early Diagnosis Of Vascular Disease To Improve Outcomes https://medtech.pharmaintelligence.informa.com/MT144796/Abbott-Focuses-On-Improving-Early-Diagnosis-Of-Vascular-Disease-To-Improve-Outcomes
Exec Chat: Medtronic’s Linnea Burman Targets ‘Consensus-Driven Care’ Using AI, Robotics in Spine Care https://medtech.pharmaintelligence.informa.com/MT144753/Exec-Chat-Medtronics-Linnea-Burman-Targets-ConsensusDriven-Care-Using-AI-Robotics-In-Spine-Care
Medtronic Partners With Rune Labs To Explore New Frontiers In Deep Brain Stimulation https://medtech.pharmaintelligence.informa.com/MT144681/Medtronic-Partners-With-Rune-Labs-To-Explore-New-Frontiers-In-Deep-Brain-Stimulation
Cala Health Hopes To Jolt Essential Tremor Market With Wrist-Worn Non-Invasive Stimulation https://medtech.pharmaintelligence.informa.com/MT144742/Cala-Health-Hopes-To-Jolt-Essential-Tremor-Market-With-Wrist-Worn-Non-Invasive-Stimulation
Northwell Health And Aegis Ventures Form An Artificial Intelligence Joint Venture https://medtech.pharmaintelligence.informa.com/MT144673/Northwell-Health-And-Aegis-Ventures-Form-An-Artificial-Intelligence-Joint-Venture
Podcast: How Do You Protect Yourself When Your AI Makes Mistakes? https://medtech.pharmaintelligence.informa.com/MT144761/Podcast-How-Do-You-Protect-Yourself-When-Your-AI-Makes-Mistakes
AI Expert: Awareness Is Key To Managing Biases https://medtech.pharmaintelligence.informa.com/MT144747/AI-Expert-Awareness-Is-Key-To-Managing-Biases
Researchers Find Serious Cybersecurity Vulnerabilities In Siemens Operating System Software: Report https://medtech.pharmaintelligence.informa.com/MT144706/Researchers-Find-Serious-Cybersecurity-Vulnerabilities-In-Siemens-Operating-System-Software-Report
US FDA-Sponsored Cybersecurity Threat Modeling Playbook Tries To Make It Simple https://medtech.pharmaintelligence.informa.com/MT144784/US-FDA-Sponsored-Cybersecurity-Threat-Modeling-Playbook-Tries-To-Make-It-Simple
Minute Insight: Kaia Health Stretches Access To Online Physical Therapy With Luna Deal https://medtech.pharmaintelligence.informa.com/MT144711/Minute-Insight-Kaia-Health-Stretches-Access-To-Online-Physical-Therapy-With-Luna-Deal
Minute Insight: Philips Continues Building Monitoring Business By Acquiring Cardiologs https://medtech.pharmaintelligence.informa.com/MT144704/Minute-Insight-Philips-Continues-Building-Monitoring-Business-By-Acquiring-Cardiologs
Cures 2.0 Throws MCIT A Lifeline, And More https://medtech.pharmaintelligence.informa.com/MT144735/Cures-20-Throws-MCIT-A-Lifeline-And-More
Telehealth Advocates Disappointed, Reenergized To Get Coverage For Older Diabetes Patients
https://medtech.pharmaintelligence.informa.com/MT144702/Telehealth-Advocates-Disappointed-Reenergized-To-Get-Coverage-For-Older-Diabetes-Patients
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In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.
Medtech Insight articles addressing topics discussed in this episode: FDA Official: Uptick In PMA, 510(k) Applications Calls For More User Fee Dollars https://medtech.pharmaintelligence.informa.com/MT144795/FDA-Official-Uptick-In-PMA-510k-Applications-Calls-For-More-User-Fee-Dollars
MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance https://medtech.pharmaintelligence.informa.com/MT144544/MDUFA-IV-Report-US-FDA-Needs-To-Publish-Digital-Health-Guidance
US FDA’s Shuren Promises MDUFA Update ‘Relatively Soon’ https://medtech.pharmaintelligence.informa.com/MT144512/US-FDAs-Shuren-Promises-MDUFA-Update-Relatively-Soon
MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds https://medtech.pharmaintelligence.informa.com/MT144183/MDUFA-V-Industry-FDA-Tangle-Over-TAP-Program-Agency-Finances-Reinstatement-Of-FifthYear-Offset-Funds
MDUFA V: FDA And Industry Still At Odds Over Carryover Funds, Vacancies, Meeting Commitments https://medtech.pharmaintelligence.informa.com/MT143859/MDUFA-V-FDA-And-Industry-Still-At-Odds-Over-Carryover-Funds-Vacancies-Meeting-Commitments
Nearly three quarters of the UK adults suffer from sleep problems, yet the majority of them do not seek help. In this episode, HBW Insight's Senio Editor, Europe, David Ridley, speaks to Perrigo VP and PAGB president Neil Lister about what consumer healthcare companies can do to help sleep-deprived British consumers. We talk about UK sleep brand Nytol-owner Perrigo's new report, State of the Market Report on Sleep, and how adjacencies in the OTC sleep category offer opportunities for self-care product innovation.
Pink Sheet reporters and editor review Acting Commissioner Janet Woodcock’s long career at the US FDA and update Robert Califf’s confirmation process, consider the advisory committee decision on Merck’s oral COVID-19 treatment, and discuss an under-the-radar case on 340B policy at the US Supreme Court.
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.
APAC Podcast: Policies Play Out Against Pandemic, Corporate Activity Remains Strong by Informa
Medtech Insight spoke with Sidley Austin attorneys about the future of medical device AI negligence litigation and what manufacturers can do to protect themselves.
In this episode, HBW Insight’s US and EU Managing Editors Malcolm Spicer and Tom Gallen analyse Q3 OTC business trends, including why the biggest pharmaceutical companies in the world are spinning out their consumer health businesses to create new, publicly listed standalone firms and what's causing the supply chain troubles that are driving up OTC product prices.
Pink Sheet reporters and editors discuss the authorization of COVID-19 vaccine booster shots for all adults, Aduhelm’s impact on Medicare Part B and rejection by EMA, and the nomination of ex-FDA commissioner Robert Califf for another term.
In this edition of Device Week, Medtech Insight’s Reed Miller chats to Marion Webb about the recent announcement that Johnson & Johnson will split into two separate businesses – one focusing on medical products, and the other focusing on consumer. Reed and Barnaby also discuss recent results from the UK’s 100,000 Genome project, and how its analysis partner, Congenica, hopes to deliver personalized medicine through widescale genomic testing
Medtech Insight articles addressing topics discussed in this episode:
J&J To Split Consumer From Medtech and Pharmaceutical Businesses – Creating Two Companies To Unlock More Value, Growth, Innovation - https://medtech.pharmaintelligence.informa.com/MT144717/JJ-To-Split-Consumer-From-Medtech-and-Pharmaceutical-Businesses--Creating-Two-Companies-To-Unlock-More-Value-Growth-Innovation
- Congenica Tries To Bring Clarity To Personalized Medicine For Rare Diseases -https://medtech.pharmaintelligence.informa.com/MT144723/Congenica-Tries-To-Bring-Clarity-To-Personalized-Medicine-For-Rare-Diseases
In this episode of Speaking Of Medtech we discuss the regulatory side of digital health – that is, the US FDA side of digital – and some of the more important related policies and activities that are going on at the agency right now. Medtech Insight articles addressing topics discussed in this episode: • What Does ‘Digital’ Mean For FDA’s Device Center? - https://medtech.pharmaintelligence.informa.com/MT144553/What-Does-Digital-Mean-For-FDAs-Device-Center
On this week’s podcast: The US FDA finally issued a draft guidance for medical software in the premarket space, while an agency panel meeting focused on the safety of graft stents. Medtech Insight articles addressing topics discussed in this episode: • FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says • Bleeding Risks Still A Concern For Patients With Endologix Stent Grafts: FDA Advisory Panel
In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb and Ferdous (Danny) Al-Faruque provide a recap of our digital health coverage in October including updates on the digital therapeutics sector and FDA guidance documents.
Medtech Insight articles addressing topics discussed in this episode: https://medtech.pharmaintelligence.informa.com/MT144573/Pear-Therapeutics-Obtains-First-Medicaid-Coverage-For-PDTs https://medtech.pharmaintelligence.informa.com/MT144574/PDT-Company-Better-Therapeutics-Ready-To-Go-Public-With-SPAC-Deal https://medtech.pharmaintelligence.informa.com/MT144614/CTAs-Standards-For-Digital-Therapeutics-Clears-Up-Industry-Confusion https://medtech.pharmaintelligence.informa.com/MT144620/Cardiovascular-CatchUp-TAVR-Withstands-Delta-Virus-So-Far-Stereotaxis-Robot-Succeeds-In-Trial https://medtech.pharmaintelligence.informa.com/MT144568/FDA-Clears-Withings-Smart-Watch-For-Detecting-AF-and-Measuring-Blood-Oxygen https://medtech.pharmaintelligence.informa.com/MT144610/Market-Intel-Lessons-Learned-From-COVID-19-A-Global-Perspective-On-Digital-Health-Transformation https://medtech.pharmaintelligence.informa.com/MT144628/23andMe-Acquires-Telehealth-Company-Lemonaid-Health-For-$400M https://medtech.pharmaintelligence.informa.com/MT144629/FDA-Guidance-Priorities-For-FY-2022-Include-Transitioning-EUAs-List-Includes-CDS-Software-Again https://medtech.pharmaintelligence.informa.com/MT144650/US-UK-Canada-Agree-On-Good-Machine-Learning-Practices https://medtech.pharmaintelligence.informa.com/MT144625/Notified-Bodies-Group-New-Euro-AI-Regs-Could-Cause-Undue-Burdens
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In this episode, HBW Insight Senior Editor David Ridley chats with Bayer’s Daniella Foster about the emerging self-care movement. Daniella is global vice president and Head of Public Affairs, Science & Sustainability for Bayer Consumer Health. We dive deep into what is driving the self-care movement and some of the challenges industry faces in building this movement in a purposeful way as we come out of the pandemic.
Pink Sheet reporters and editors discuss the congressional agreement to allow Medicare drug pricing negotiations, the authorization of the Pfizer/BioNTech vaccine for children age 5 to 11, and the departure of the US FDA’s Chief Scientist.
In this week’s podcast, Medtech Insight's US Commercial manager Reed Miller provides an overview of Medtronic’s “refreshed brand” on environmental, social and governance targets. Managing editor Marion Webb highlights her deep-dive pieces on CEO post-pandemic perspectives while UK-based reporter Barnaby Pickering provides an analyst perspective on price targets following poor SPAC reception.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
CEO Perspectives: COVID Impacts On Supply Chain, Digital, At-Home Care, And Medtech’s Place In ‘Food Chain’
Leading Medtech CEOs Say Health Equity, Environmental Work Will Outlast Pandemic
Analyst Insight: Justifying A Price Target Following Poor SPAC Reception
Medtronic ‘Refreshes Brand,’ Announces New Environmental, Social, and Governance Targets Leading Medtech CEOs Say Health Equity, Environmental Work Will Outlast Pandemic
In this episode of Speaking Of Medtech we talk about arguably one of the biggest regulatory changes to come down the pike in decades: the ongoing harmonization of the US FDA’s QSR, which is going to broadly change the way the agency handles medical device quality oversight. Medtech Insight articles addressing topics discussed in this episode: • QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg • QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo • FDA’s Draft QSR: ‘Lucy’ Pulled The Football Away. Again
On this week’s podcast: The US FDA put some teeth to its regulation of the implants by issuing several new mandates, including a requirement that surgeons warn patients about the risks of the devices prior to surgery. Also this week the agency released its annual list of priority guidance documents. Medtech Insight articles addressing topics discussed in this episode: • FDA Strengthens Safety Requirements For Breast Implants https://medtech.pharmaintelligence.informa.com/MT144648/FDA-Strengthens-Safety-Requirements-For-Breast-Implants • FDA Guidance Priorities For FY 2022 Include Transitioning EUAs; List Includes CDS Software Again https://medtech.pharmaintelligence.informa.com/MT144629/FDA-Guidance-Priorities-For-FY-2022-Include-Transitioning-EUAs-List-Includes-CDS-Software-Again
Pink Sheet reporters and editors discuss the issues that could arise when the COVID-19 vaccines are given to children age 5 to 11, Merck’s agreement to share the license for its proposed oral COVID-19 treatment, and problems for a sponsor blocked by an accelerated approval conversion to full approval.
Boehringer Ingelheim India Chief On Strategy, Jardiance Challenge, Gender Balance In Pharma by Informa
Following the publication of its Self-Care Readiness Index, HBW Insight's David Ridley speaks to Global Self-Care Federation chair Heiko Schipper about what it takes to build a worldwide movement for self-care. We also discuss how industry players like Bayer Consumer Health - which Schipper heads up as division president - can contribute, for example as 'truth leaders' in an age of misinformation and public mistrust and as partners for community pharmacy, which still has an important role to play in the 21st century.
In this edition of Device Week, Medtech Insight’s Reed Miller discusses some important news from Medtronic and Marion Webb reviews the first of two feature articles on the impact of the pandemic on the medtech industry around the world.
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The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider.
Medtech Insight articles addressing topics discussed in this episode:
https://medtech.pharmaintelligence.informa.com/MT144610/Market-Intel-Lessons-Learned-From-COVID-19-A-Global-Perspective-On-Digital-Health-Transformation
https://medtech.pharmaintelligence.informa.com/MT144592/Medtronic-Pushes-Completion-Of-Pivotal-Renal-Denervation-Trial-To-Late-2022
https://medtech.pharmaintelligence.informa.com/MT144582/Medtronic-Refreshes-Brand-Announces-New-Environmental-Social-and-Governance-Targets
In this episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more. Medtech Insight articles addressing topics discussed in this episode: • Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark US/UK Clinical Trials https://medtech.pharmaintelligence.informa.com/MT123493/Breathing-Easy-ALung-CEO-Talks-Novel-Hemolung-Device-FDAs-Breakthrough-Pathway-Landmark-USUK-Clinical-Trials • US Breakthrough Devices Tracker https://medtech.pharmaintelligence.informa.com/datasets/us-breakthrough-devices
Davinderpreet Mangat and Shardha Millington discuss the current and future role of long-acting agents in HIV treatment and PrEP.
Topics covered include:
HIV treatment – 4:30 HIV PrEP – 22:45
Supporting links:
https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/viral-infections/hiv-pre-exposure-prophylaxis-hiv-prep/disease-analysis/article225313.ece
https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/viral-infections/human-immunodeficiency-virus/disease-analysis/article225293.ece
Other platforms:
Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836
Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz
TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/
Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union. Topics include discussion of ISO 13485, ongoing industry concerns with MDR implementation, and the Eudamed database expansion.
In this month’s podcast, Medtech Insight's Reed Miller and Marion Webb provide a recap of our digital health coverage in August and September, including start-ups that grabbed new funding, news from AAOS 2021 and regulatory news.
Medtech Insight articles addressing topics discussed in this episode:
Akili Pays $37.5M To License Tali’s Tech For Early Childhood Attention Impairments https://medtech.pharmaintelligence.informa.com/MT144365/Akili-Pays-375M-To-License-Talis-Tech-For-Early-Childhood-Attention-Impairments
Hagar Lands Funding To Develop Noninvasive Glucose Monitoring Watch https://medtech.pharmaintelligence.informa.com/MT144335/Hagar-Lands-Funding-To-Develop-Noninvasive-Glucose-Monitoring-Watch
Flywheel.io Raises $22M And Buys Out Competition https://medtech.pharmaintelligence.informa.com/MT144463/Flywheelio-Raises-22M-And-Buys-Out-Competition
Zoll Medical Signs Definite Agreement To Buy Itamar Medical For $538M https://medtech.pharmaintelligence.informa.com/MT144453/Zoll-Medical-Signs-Definite-Agreement-To-Buy-Itamar-Medical-For-$538M
A Closer Look At Think Surgical’s Active Open Implant Orthopedic Robot and What’s Ahead https://medtech.pharmaintelligence.informa.com/MT144506/AAOS-2021-A-Closer-Look-At-Think-Surgicals-Active-OpenImplant-Orthopedic-Robot-And-Whats-Ahead
Zimmer Biomet Canary Medical Win FDA De Novo For First Smart Knee Implant https://medtech.pharmaintelligence.informa.com/MT144400/Zimmer-Biomet-Canary-Medical-Win-FDA-De-Novo-For-First-Smart-Knee-Implant
Exec Chat: AAOS 2021 Outgoing President Bosco Discusses Hot-Button-Issues – Inpatient-Only List, Pre-Authorization, New Tech https://medtech.pharmaintelligence.informa.com/MT144412/Exec-Chat-AAOS-2021-Outgoing-President-Bosco-Discusses-HotButton-Issues--InpatientOnly-List-PreAuthorization-New-Tech
Market Intel: Robotic Surgery Holds Great Promise, But Is Not Quite There Yet https://medtech.pharmaintelligence.informa.com/MT144388/Market-Intel-Robotic-Surgery-Holds-Great-Promise-But-Is-Not-Quite-There-Yet
New FDA Web Page Spotlights AI/ML Progress https://medtech.pharmaintelligence.informa.com/MT144493/New-FDA-Web-Page-Spotlights-AIML-Progress
MDIC Digital Health Initiative Could Be Crucial To FDA Pre-Cert Program https://medtech.pharmaintelligence.informa.com/MT144390/MDIC-Digital-Health-Initiative-Could-Be-Crucial-To-FDA-Pre-Cert-Program
FDA Greenlights First-Of-Its-Kind Heart Software https://medtech.pharmaintelligence.informa.com/MT144454/FDA-Greenlights-First-Of-Its-Kind-Heart-Software
Another Set Of Eyes: US FDA Authorizes AI Software To Spot Prostate Cancer https://medtech.pharmaintelligence.informa.com/MT144487/Another-Set-Of-Eyes-US-FDA-Authorizes-AI-Software-To-Spot-Prostate-Cancer
Expert: AI/ML Pediatric Software Brings Hope – But Also Potential – To Magnifying Disparities https://medtech.pharmaintelligence.informa.com/MT144425/Expert-AIML-Pediatric-Software-Brings-Hope--But-Also-Potential--To-Magnifying-Disparities
FDA Panel Meeting To Focus On AI/ML Device Labeling, Transparency https://medtech.pharmaintelligence.informa.com/MT144379/FDA-Panel-Meeting-To-Focus-On-AIML-Device-Labeling-Transparency
Congress Marks First Telehealth Awareness Week https://medtech.pharmaintelligence.informa.com/MT144501/Congress-Marks-First-Telehealth-Awareness-Week
For more information on Medtech Insight and to start a free trial, click here:
http://bit.ly/2w7LnlR
Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.
Device Week, Oct. 08, 2021 – Boston Scientific Acquisition, And Poor SPAC Float
In this edition of Device Week, Medtech Insight’s Reed Miller discusses Boston Scientific’s acquisition of Baylis, and what it means for its heart business. UK-based reporter Barnaby Pickering looks into LumiraDX’s recent float on the stock market, and why it might have been so poorly received.
Medtech Insight articles addressing topics discussed in this episode:
-
Boston Scientific Continues Acquisition Streak With $1.75Bn Deal For Baylis’ Cardiology Products
-
LumiraDX Goes Public In SPAC Merger
Canadian biotech Providence Therapeutics CEO talks to Scrip on mRNA vaccines against COVID-19, cancer
Shownotes – Providence Therapeutics CEO Brad Sorenson talks about his company’s plans for Phase II, III clinical trials for an mRNA vaccine as well as marketing and manufacturing partnerships with Biological E, Everest Medicines, Emergent Biosolutions and Northern RNA. He also discusses Providence’s m-RNA vaccines against cancer
In the inaugural episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt discuss remote facility inspections and question whether they’re the wave of the future.
Medtech Insight articles addressing topics discussed in this episode:
• Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections https://medtech.pharmaintelligence.informa.com/MT144289/Come-On-In-The-Waters-Fine-FDA-Should-Fully-Embrace-Remote-Inspections
• Enforcement Comeback? FDA Predicts 1,767% Increase In US Inspections In FY ’22, Matching Pre-Pandemic Levels https://medtech.pharmaintelligence.informa.com/MT143997/Enforcement-Comeback-FDA-Predicts-1767-Increase-In-US-Inspections-In-FY-22-Matching-PrePandemic-Levels
• To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments https://medtech.pharmaintelligence.informa.com/MT144053/To-RRA-Or-Not-To-RRA-BD-Talks-DecisionMaking-Around-FDA-Requests-For-Remote-Regulatory-Assessments
• ‘We Were A Victim’: How An FDA Remote Regulatory Assessment Took One Device Maker By Surprise https://medtech.pharmaintelligence.informa.com/MT143998/We-Were-A-Victim-How-An-FDA-Remote-Regulatory-Assessment-Took-One-Device-Maker-By-Surprise
In this week’s podcast, reporters discuss the high points of the recent AdvaMed MedTech Conference. Ferdous Al-Faruque goes in-depth on FDA comments about user fees, while Brian Bossetta discusses varying points of view on Medicare coverage of breakthrough devices – including the crucial role of real-world evidence.
Pink Sheet reporters and editors look at the search for COVID-19 vaccine correlates of protection, a potential effort to simplify the US FDA’s expedited approval pathways, and new guidance on the use of real-world evidence.
Ex-Hilleman CEO talks to Scrip on COVID-19 vaccines and challenges as the disease becomes endemic
On this week’s podcast: One of the more interesting and important trends in medtech in recent years is the emergence of robotic assisted surgery. But as RAS procedures increase, so do the chances of something going wrong. And when it does, who’s to blame? The robot or the surgeon? Medtech Insight articles addressing topics discussed in this episode: • More Robots In The Operating Room Could Mean More Lawsuits In The Courtroom (https://medtech.pharmaintelligence.informa.com/MT144478/More-Robots-In-The-Operating-Room-Could-Mean-More-Lawsuits-In-The-Courtroom)
HBW Insight's David Ridley speaks to regulatory expert and TheScienceGrad founder Natash Barrow about trust in self-care, and how consumer healthcare companies can become a 'source of truth' in a confusing and misleading world.
In this edition of Device Week, Medtech Insight’s Marion Webb gives a summary of this year’s American Academy Of Orthopedics annual meeting, where she discusses new products from a range of companies, and interesting meetings with executives. UK-based reporter Barnaby Pickering sheds light on Owlstone Medical’s new diagnostic method, and Editor Reed Miller highlights a story about the troubled Stereotaxis.
Medtech Insight articles addressing topics discussed in this episode:
Zoll Medical Signs Definite Agreement To Buy Itamar Medical For $538M - https://medtech.pharmaintelligence.informa.com/MT144453/Zoll-Medical-Signs-Definite-Agreement-To-Buy-Itamar-Medical-For-$538M
AAOS 2021: Digital Tools In Surgical Ecosystem, Software-Enabled Tech, Robots, Wearables, Sensors - https://medtech.pharmaintelligence.informa.com/MT144444/AAOS-2021-Digital-Tools-In-Surgical-Ecosystem-SoftwareEnabled-Tech-Robots-Wearables-Sensors
Stereotaxis Continues Its Turnaround, Bringing Robots To Endovascular Intervention - https://medtech.pharmaintelligence.informa.com/MT144456/Stereotaxis-Continues-Its-Turnaround-Bringing-Robots-To-Endovascular-Intervention
Owlstone Medical Secures Funding To Develop Its Breath Biopsy Technology - https://medtech.pharmaintelligence.informa.com/MT144446/Owlstone-Medical-Secures-Funding-To-Develop-Its-Breath-Biopsy-Technology
Pink Sheet reporters and editors discuss new developments in US drug pricing reform, FDA considering mandatory opioid prescriber education again, and including China in the agency’s international parallel review initiative, Project Orbis.
Pink Sheet reporters and editors consider the leadership shake-up at the FDA Office of Vaccines Research and Review, the COVID-19 vaccine booster shot debate, and the impact of new safety measures for several JAK inhibitors.
Davinderpreet Mangat, David Dahan, and Ellie Davenport discuss new developments in the diffuse large B-cell lymphoma (DLBCL) and melanoma space.
Topics covered include: • DLBCL – CAR-T therapies: 1:23 • DLBCL – Polivy: 12:40 • Melanoma – Lifileucel: 20:20 • Melanoma – Keytruda: 27:25
Supporting links:
https://service.datamonitorhealthcare.com/hkc/disease/oncology/lymphoma/diffuse-large-B-cell-lymphoma/ https://service.datamonitorhealthcare.com/hkc/disease/oncology/skin-cancer/malignant-melanoma/disease-analysis/article223365.ece https://www.biomedtracker.com/EventDetail.cfm?EventID=416767 https://www.biomedtracker.com/EventDetail.cfm?EventID=418078 https://www.biomedtracker.com/EventDetail.cfm?EventID=422214 https://www.biomedtracker.com/EventDetail.cfm?EventID=421354 https://www.biomedtracker.com/EventDetail.cfm?EventID=421183
Other platforms:
Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
In this week’s podcast, Marion Webb discusses the future of robotic surgery and Barnaby Pickering breaks down the trauma fixation device market.
The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider. Medtech Insight: articles addressing topics discussed in this episode:
Market Intel: Robotic Surgery Holds Great Promise, But Is Not Quite There Yet
Exec Chat: AAOS 2021 Outgoing President Bosco Discusses Hot-Button Issues – Inpatient-Only List, Pre-Authorization, New Tech
Amulet IDE Trial Supports Abbott’s New LAA Closure Device
Infographic: Fracture Fixation Devices Market Projected A Return To Steady Growth
Zimmer Biomet, Canary Medical Win FDA De Novo For First Smart Knee Implant
In both the US and EU, we are seeing a push for large-scale cosmetics regulation, with the Personal Care Products Safety Act and European Green Deal respectively. For HBW Insight executive editor Ryan Nelson, this raises questions about what and whom it will serve ultimately, particularly when compared with the burdens being levied on industry and the repressive effects on small business, free competition, and innovation.
On this week’s podcast we discuss the US agency’s final regulation on the intended use of products, which device makers must follow beginning on 1 September. Medtech Insight articles addressing topics discussed in this episode: • FDA Widens Scope In Considering Evidence For Off-Label Use
In this month’s podcast, Medtech Insight's Reed Miller and Marion Webb provide a recap of our digital health coverage in July, including start-ups that grabbed new funding, product launches and regulatory clearances.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Exec Chat: New CEO of Digital Therapeutics Alliance Says Reimbursement Remains Big Issue
Handheld Ultrasound Developer Exo Raised $200M In Series C
Babson Diagnostics Plans To Deliver What Theranos Could Not
Spire Health Closed A $38M Financing Round To Expand Commercialization Of Respiratory Remote Patient Monitoring Platform
Signifier Medical Technologies Raises $35M In Series D
Happify Health Launches Prescription Digital Therapeutics To Treat Depression Or Anxiety
HeartFlow Wants To Accelerate Adoption Of Al-Powered Heart Disease Test With $24Bn SPAC Deal
Carrot’s Pivot Breath Sensor Helps Motivate Smokers To Quit
Paige Obtains NHSx Award Allowing It To Launch AI Prostate Test
Biden Admin Looks To Broaden Telehealth, Increase Access To Mental Health Care
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Pink Sheet reporter explains the increased pressure on the FDA now that a coronavirus vaccine booster plan is in place, the surprising results of a survey of agency advisory committee members, and the recalculation of FY 2022 PDUFA fees.
In this week’s podcast, Medtech Insight's US Commercial manager Reed Miller provides an overview of Abbott’s Amplatzer Amulet, which was approved by the US FDA for preventing thrombus embolization in patients with nonvalvular atrial fibrillation. Managing editor Marion Webb discusses Zimmer Biomet’s FDA clearance of its Rosa robotic surgery platform for total hip replacement and the intensifying competition in the rising surgical robotics market.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
As the entry deadline (1 September) for the UK OTC Marketing Awards approaches, HBW Insight Senior Editor David Ridley talks to multi-award-winning agency Satellite PR's Pauline Kent about how to put together a winning entry.
In this week’s podcast, we take a look at the concerns a US FDA advisory panel recently expressed about Keystone Heart’s TriGUARD 3, then discuss some expert predictions on the FDA’s hotly anticipated Quality System Regulations (QSR) rewrite.
Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull is gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump Administration’s most favored nation rule.
Pink Sheet reporters and editor discuss the inspector general assessment of the US FDA’s approval of Aduhelm as well as the accelerated approval program, the FDA race to finish its review of the Pfizer/BioNTech COVID-19 vaccine BLA, and the lack of agency advisory committee meetings.
In this edition of Device Week, Medtech Insight’s Barnaby Pickering discusses a market intelligence report about robotically assisted surgery. Reed Miller discusses exciting mergers in the medtech space, paying focus to a company looking to image damage to the heart in order to spot potential heart attacks before they happen.
Medtech Insight articles addressing topics discussed in this episode:
- Market Intel: Expanding Applications And Improved Offerings To Drive Robotically Assisted Surgery Market - https://medtech.pharmaintelligence.informa.com/MT144294/Market-Intel-Expanding-Applications-And-Improved-Offerings-To-Drive-Robotically-Assisted-Surgery-Market
Scrip Podcast: Sanofi India Chief, Ex-GSK Exec Discuss Pharma’s Digitization Journey by Informa
Pink Sheet reporters and editors discuss Viatris receiving the first interchangeable biosimilar designation, CMS hearing from stakeholders about Aduhelm and other Alzheimer’s drugs, and concerns about expanding pediatric coronavirus vaccine trials to look for rare adverse events.
On this week’s podcast we highlight US Medicare reimbursement topics that industry should keep an eye on, and discuss important regulatory changes underway in the UK. Medtech Insight articles addressing topics discussed in this episode: • Latest Physician Fee Schedule Proposal Could Impact Companies’ Bottom Line • Glaukos Takes Another Hit From CMS; Investors Respond Negatively As Stock Falls • Biden Admin Looks To Broaden Telehealth, Increase Access To Mental Health Care • UK ABHI Perspectives On Enabling Regulation – Part 1: Regulatory Certainty Vital For Medtechs • MHRA Must Seize UK Digital And Diagnostics Opportunity: ABHI Perspectives On Enabling Regulation – Part 2 • MDR Makes EU ‘Much Less Attractive’ For Start-Ups, Says Medtronic EMEA Chief
This week– J&J’s outlook for coronavirus vaccines, Cosentyx comes in strong for Novartis, Biogen’s views on Aduhelm pricing, competition in the “dustat” sector, and dealing with endemic COVID-19.
Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.
In this edition of Device Week, Medtech Insight’s Marion Webb discusses the huge number of digital health deals being done at the moment, including exciting developments in the SPAC space. UK-based reporter Barnaby Pickering talks about Angle, a British liquid diagnostics company that has developed a novel approach to liquid diagnostics.
- Exec Chat: Pear Therapeutics’ CEO Charts Future For Digital Therapeutics Following SPAC Deal - https://medtech.pharmaintelligence.informa.com/MT144127/Exec-Chat-Pear-Therapeutics-CEO-Charts-Future-For-Digital-Therapeutics-Following-SPAC-Deal
- HeartFlow Wants To Accelerate Adoption Of AI-Powered Heart Disease Test With $2.4Bn SPAC Deal - https://medtech.pharmaintelligence.informa.com/MT144222/HeartFlow-Wants-To-Accelerate-Adoption-Of-AIPowered-Heart-Disease-Test-With-24Bn-SPAC-Deal
- Angle Will Reshape Liquid Diagnostics By Capturing Circulating Tumor Cells - https://medtech.pharmaintelligence.informa.com/MT144198/Angle-Will-Reshape-Liquid-Diagnostics-By-Capturing-Circulating-Tumor-Cells
HBW Insight talks to the Global Self Care Federation's director general, Judy Stenmark, about the impact of pandemic on global self-care industry, as well as what GSCF is doing to promote self-care in the wake of the pandemic. Marking International Self-Care Day (24 July) Stenmark tells HBW Insight's Senior Editor (EU) David Ridley about the GSCF's "Self-Care Promise" initiative, its work on producing an index to analyse the self-care readiness of national health systems, as well as ongoing projects in self-care economics and sustainability.
Davinderpreet Mangat, Pamela Spicer, Jessica Merrill, and Catherine Kelly discuss the approval of Aduhelm in Alzheimer’s disease.
Topics covered include: • Drug development and approval - 01:45 • Pricing and commercial potential - 15:12 • National reimbursement processes - 30:55
Supporting links: • Datamonitor’s Alzheimer’s Disease Analysis report - https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/alzheimers-disease/disease-analysis/article209751.ece • Biogen: Aduhelm’s Price Is Part Of Alzheimer’s ‘Evolution’ - https://scrip.pharmaintelligence.informa.com/SC144754/Biogen-Aduhelm-Price-Is-Part-Of-Alzheimers-Evolution • Medicare Coverage Analysis Of Alzheimer’s Drugs Begins With Focus On Outcomes, Patient Eligibility - https://pink.pharmaintelligence.informa.com/PS144631/Medicare-Coverage-Analysis-Of-Alzheimers-Drugs-Begins-With-Focus-On-Outcomes-Patient-Eligibility
Other platforms: • Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 • Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz • TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ • Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67
This year’s CPhI Pharma Awards will be taking place on 9th November and entries for 2021 are open! Listen to the CPhI Pharma Awards podcast in order to find out more on how the entry process works, the categories for this year and tips on how to improve your entry’s odds. The entry deadline is 6th August.
In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb and Barnaby Pickering offer a recap of Medtech Insight’s digital health coverage in June, including the record-breaking H1 digital health funding, a recap of ADA 2021 and updates on telehealth legislation.
Medtech Insight articles addressing topics discussed in this episode:
Quanta Raises $245M In Series D, Plans To Expand Into Home-Based Dialysis In US https://medtech.pharmaintelligence.informa.com/MT144130/Quanta-Raises-245M-In-Series-D-Plans-To-Expand-Into-HomeBased-Dialysis-In-US
CMR Surgical Closes SoftBank-Led Funding Round Worth $600M https://medtech.pharmaintelligence.informa.com/MT144132/CMR-Surgical-Closes-SoftBank-Led-Funding-Round-Worth-$600M
Pear Therapeutics Goes Public To Support Expansion Of Prescription Digital Therapeutics https://medtech.pharmaintelligence.informa.com/MT144127/Exec-Chat-Pear-Therapeutics-CEO-Charts-Future-For-Digital-Therapeutics-Following-SPAC-Deal
ADA 2021: Encouraging Trial Data on CGMs, Insulin Pens, Digital Solutions, And More https://medtech.pharmaintelligence.informa.com/MT144145/ADA-2021-Encouraging-Trial-Data-On-CGMs-Insulin-Pens-Digital-Solutions-And-More
Exec Chat: Dexcom Continues To Evolve Blood Glucose Measurement Market https://medtech.pharmaintelligence.informa.com/MT144175/Exec-Chat-Dexcom-Continues-To-Evolve-Blood-Glucose-Measurement-Market
Cures 2.0 Would Circumvent CMS’ Pause On Breakthrough Payment Rule, Improve Telehealth, And More https://medtech.pharmaintelligence.informa.com/MT144113/Cures-20-Would-Circumvent-CMS-Pause-On-Breakthrough-Payment-Rule-Improve-Telehealth-And-More
MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds https://medtech.pharmaintelligence.informa.com/MT144183/MDUFA-V-Industry-FDA-Tangle-Over-TAP-Program-Agency-Finances-Reinstatement-Of-FifthYear-Offset-Funds
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
This week – pharma’s Q2 prospects; Bayer’s plans for the US launch of its CKD drug; big tobacco takes further steps into healthcare; KRAS’s emergence in oncology amid ongoing challenges; and tips for European biotech fundraising.
In this week’s podcast, EU regulatory editor Amanda Maxwell walks us through the latest news and documents coming out of the European Union’s efforts to revamp its medical device and diagnostics rules and makes some predictions about what we can expect to see going forward.
Pink Sheet reporters and editors discuss another explanation of the FDA’s Aduhelm label, the first lawsuit attempting to force the sale of samples for generic development, and the agency questioning promotion of Amgen’s Neulasta.
It is an interview with 2 ABHI executives about the post-Brexit transition to standalone regulation for devices in the UK. About 27 minutes in length.
In this week’s podcast, Medtech Insight editors Marion Webb and Reed Miller discuss the latest news from the American Diabetes Association conference as well as an interview with Dexcom CEO Kevin Sayer about the company’s strategy in the blood glucose measurement market.
The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud and TuneIn - and also now on Spotify Podcasts - and via smart speakers if one of these platforms has been set up as your default podcast provider.
Articles discussed in this podcast:
Dexcom, Abbott File Dueling Lawsuits On Diabetes Management Technology
Exec Chat: Dexcom Continues To Evolve Blood Glucose Measurement Market
ADA 2021: Encouraging Trial Data On CGMs, Insulin Pens, Digital Solutions, And More
Needles Are Out, Future Tech Is In, For Blood Glucose Measurement
Market Intel: Glucose Monitor Market Set To Explode As Patients Access Better Devices
Pink Sheet reporters and editors discuss the implications of Aduhelm’s updated indication, CDER’s new drug approvals in the first half of 2021, and an FTC policy change that will make investigating pharma easier.
In this week’s podcast, senior reporter Ferdous Al-Faruque discusses the most interesting tidbits from his recent interview with US FDA device center chief Jeff Shuren, and managing editor Elizabeth Orr offers updates on what two recent Supreme Court patent decisions could mean for medtech.
Pink Sheet reporters and editors discuss new Aduhelm documents explaining the FDA’s views on the accelerated approval, comments from the former FDA commissioner on his tenure and future, and options for improving advisory committee meetings.
David Dahan, Ellie Davenport, Tom Tyler and Zachary McLellan discuss the 2021 ASCO conference.
Topics covered include: CheckMate 648 trial, Opdivo in Esophageal Cancer - 00:47 VISION trial, 177Lu-PSMA-617 in Prostate Cancer – 08:20 RELATIVTY-047 trial, Relatlimab and Opdivo in Melanoma – 15:36 CARTITUDE-1 trial, Cilta-cel in Multiple Myeloma – 19:45 ELEVATE-RR trial, Calquence vs. Imbruvica in Chronic Lymphocytic Leukemia – 26:01
The head of the US agency’s device center spoke with Medtech Insight in a wide-ranging interview about his priorities for the future, the nuances of the MDUFA V user-fee negotiations, how COVID-19 has changed the agency, and more.
In this bonus edition of HBW Insight's new 'Over The Counter' podcast, David Ridley (Senior Editor, EU), speaks to the PAGB's Michelle Riddalls about the association's upcoming Digital Week event (5th to 9th July) and the promise of digitalization for the UK consumer healthcare industry. In this wide-ranging interview, we discuss how digital adoption by industry and consumers has been accelerated by the pandemic, as well as the opportunities and challenges of the recent e-commerce boom and how this highlights the need for consumer digital literacy. Social media influencers, mobile health apps and wearables and real-world data/evidence are all also on the agenda.
In this edition of Device Week, Medtech Insight's UK-based reporter Barnaby Pickering provides an insight into Procyrion’s novel device for decongesting cardiorenal syndrome patients. US Commercial and R&D manager, Reed Miller, highlights details on Pear Therapeutics’ recent SPAC acquisition, and managing editor, Marion Webb, discusses two companies that received types of approval for novel devices.
Medtech Insight articles discussed in this week’s episode:
Onward Secures FDA Breakthrough Designation To Improve Movement, Quality Of Life After Spinal Cord Injuries
Start-Up Spotlight: Procyrion Trials Novel Device To Tackle Cardiorenal Syndrome
In this edition of HBW Insight's new 'Over The Counter' podcast, David Ridley (Senior Editor, EU), talks to Canna Consultants' Steve Oliver about the current state of CBD regulation in the UK and European Union. Specifically, we discuss what is going on with the hundreds of CBD novel food applications submitted to the UK Food Standards Agency and why only four synthetic CBD novel food applications have been validated by the European Commission so far. We also speculate about the possibility of CBD becoming an OTC medicinal ingredient in the future.
Podcast Time Stamps 00:08 Introduction 01:01 The spin-off from Merck: The world needs a company like Organon 03:13 Taking a broad view on women’s health - beyond reproductive health 05:24 Wall of Voices – Listening to the needs and challenges of women 10:32 Partnering and Inorganic Growth 12:51 The cultural fit for alliances 14:06 Majority-female board of directors 15:50 Renewed focus on established products portfolio, life cycle management 19:07 Biosimilars franchise 21:30 Putting women’s health high up on the agenda
On this week’s podcast we give an update on the Medical Device User Fee Amendments (MDUFA V) process. We also discuss US FDA device center director Jeff Shuren’s comments about pre-submission meetings and IVD submissions during a recent podcast interview with AdvaMed. Finally, we discuss the FDA’s latest scheduling of the release of its draft harmonized Quality System Regulation, due out this month.
Medtech Insight articles addressing topics discussed in this episode: • MDUFA V: FDA Proposes New Program To Engage External Experts Early – But Industry’s Skeptical • ‘A New Kind Of Future’? FDA’s Shuren Questions Whether Engagement With Industry Will Change Post-Pandemic • IVDs: ‘Every Non-COVID Premarket Submission That Was Held Up Is Moving Forward’ Soon, FDA’s Shuren Vows • After 3 Years Of Work, FDA Says It Will Release Its Revamped Quality System Regulation This Month
Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.
In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, Barnaby Pickering and Danny Al-Faruque offer a recap of our digital health coverage in May and early June, including the latest Market Intel on the “Future of Surgery” focusing on immersive technologies, an interview with the author of “The Digital Pill” and US FDA news on Verily, Cognoa and cybersecurity standards.
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Market Intel: How Augmented, Mixed And Virtual Reality Unveils New Possibilities For Surgeons
Market Intel: Medtechs, Surgeons Embrace ‘Virtual Operating Theater’ As New Reality
First-Of-Its-Kind Autism Software Could Help Diagnose, Treat Children Faster: FDA
Verily’s Study Watch Rejected By FDA As Parkinson’s Drug-Development Tool
FDA Says SBOMs Are Key To Better Cybersecurity In NIST Report
‘The Digital Pill’ Author Sees Digital As Catch-All Solution For Health Care
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Medtech Insight articles addressing topics discussed in this episode:
Outside the EU, the UK is setting its own regulatory standards and has a remit to promote innovation, leverage international best practice, listen more closely to the patent voice and raise safety standards. Industry watches developments closely.
In this edition of HBW Insight's new 'Over The Counter' podcast, David Ridley (Senior Editor, EU) talks to University of Birmingham professor Martin Hewison about vitamin D's immunity benefits, whether it can help prevent infection with or lessen the effects of COVID-19 and what industry can do to help researchers unlock the potential of this trending dietary supplement ingredient.
In this week’s podcast, Medtech Insight's UK-based reporter Barnaby Pickering provides an update on Medtronic’s MiniMed 780G insulin pump cost-savings study, presented at the Advances Technologies & Treatments for Diabetes (ATTD) conference. US Commercial and R&D manager, Reed Miller, highlights details on CVRx’s recent IPO.
Medtech Insight articles addressing topics discussed in this episode:
ATTD 2021: Despite High Upfront Cost, Medtronic’s 780G Could Offer Cost Savings https://medtech.pharmaintelligence.informa.com/MT144044/ATTD-2021-Despite-High-Upfront-Cost-Medtronics-780G-Could-Offer-Cost-Savings
CVRx Raises $75M In IPO To Commercialize And Develop Heart Failure Therapy https://medtech.pharmaintelligence.informa.com/MT144039/CVRx-Raises-$75M-In-IPO-To-Commercialize-And-Develop-Heart-Failure-Therapy
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Podcast Time Stamps: 00:08 Introduction 00:58 IQVIA Biotech’s Latest Expansion In Japan/Asia Pacific 04:40 Diverse APAC Region, Oncology/Immunology Focus Of Biotechs, Partnering Models 11:53 Pandemic-Driven Virtualization Of Trials, Site Contracting Timelines 17:57 Digital Launch Efforts, Democratization Of Healthcare Providers’ Access To Information 21:25 Evolving Patient Journey 24:16 AI In Drug Development,Treatment
This week’s podcast highlights Medtech Insight’s coverage of Medtronic's decision to pull its HeartWare Ventricular Assist Device from the market and the implications as well as Biden's proposed budget to increase funding for the US FDA.
Pink Sheet reporters and editors discuss the end of stem cell clinic enforcement discretion, the US FDA’s projection that inspections will return to normal levels in FY 2022, and improved hiring in CDER.
Davinderpreet Mangat, Michael Haydock, and Andrew McConaghie discuss next-generation COVID-19 vaccines.
Davinderpreet Mangat, Michael Haydock, and Andrew McConaghie discuss COVID-19 vaccines and hemophilia A & B gene therapies.
Topics covered in this episode include: • COVID-19 next-generation vaccines (0:58) • Hemophilia A & B gene therapies (32:40)
This week’s podcast highlights Medtech Insight’s latest Market Intelligence report on continuous glucose monitors, a rapidly growing sector driven by innovation and patients’ demand for easier-to-use devices.
In this week’s podcast, managing editor Elizabeth Orr and executive editor Shawn Schmitt discuss breaking news out of this year’s Medcon conference, sponsored by the FDA and Xavier University. Key topics include QSR harmonization, class II recalls, the new Inspectional Affairs Council, and the breakthrough pathway.
Pink Sheet reporters and editors discuss Emergent BioSolutions’ congressional appearance, plans for the next 21st Century Cures bill, and the FDA’s statement on the clinical trials for CytoDyn’s investigational COVID-19 therapy.
How the UK can manage its own device regulatory affairs outside the EU – either alone or with partners on selected areas of work.
In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb and Barnaby Pickering offer a recap of Medtech Insight’s digital health coverage in April, including the digital transformation in the OR and clinical trials as well as remote monitoring.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
Market Intel: Medtechs, Surgeons Embrace ‘Virtual Operating Theater’ As New Reality https://medtech.pharmaintelligence.informa.com/MT143839/Market-Intel-Medtechs-Surgeons-Embrace-Virtual-Operating-Theater-As-New-Reality
Smile Train And BioDigital Introduce App To Train Surgeons In Cleft Palate Repair https://medtech.pharmaintelligence.informa.com/MT143840/Smile-Train-And-BioDigital-Introduce-App-To-Train-Surgeons-In-Cleft-Palate-Repair
Expert Panel Says Interoperability Remains Barrier In Digital Surgery Transformation https://medtech.pharmaintelligence.informa.com/MT143910/Expert-Panel-Says-Interoperability-Remains-Barrier-In-Digital-Surgery-Transformation
FDA Authorizes GI Genius As A Smarter AI-Based Colonoscopy Tool https://medtech.pharmaintelligence.informa.com/MT143777/FDA-Authorizes-GI-Genius-As-A-Smarter-AI-Based-Colonoscopy-Tool
Exec Chat: Manus Neurodynamica Will Augment Pharmaceutical Companies’ Drug Trials https://medtech.pharmaintelligence.informa.com/MT143849/Exec-Chat-Manus-Neurodynamica-Will-Augment-Pharmaceutical-Companies-Drug-Trials
Exec Chat: Cumulus Neuroscience Help Trials Collect Previously Underutilized, Vital Data https://medtech.pharmaintelligence.informa.com/MT143903/Exec-Chat-Cumulus-Neuroscience-Help-Trials-Collect-Previously-Underutilized-Vital-Data
ObvioHealth Is Building A New Digital Ecosystem To 'Revolutionize' Trials https://medtech.pharmaintelligence.informa.com/MT143811/ObvioHealth-Is-Building-A-New-Digital-Ecosystem-To-Revolutionize-Trials
Report: Q1 Sets New Digital Health Investment Record, Telehealth Continues To Take Lion’s Share https://medtech.pharmaintelligence.informa.com/MT143906/Report-Q1-Sets-New-Digital-Health-Investment-Record-Telehealth-Continues-To-Take-Lions-Share
Mayo Clinic Launches Two Companies To Support New Remote Monitoring Initiative https://medtech.pharmaintelligence.informa.com/MT143786/Mayo-Clinic-Launches-Two-Companies-To-Support-New-Remote-Monitoring-Initiative
FDA Will No Longer Regulate Certain Medical Software https://medtech.pharmaintelligence.informa.com/MT143802/FDA-Will-No-Longer-Regulate-Certain-Medical-Software
HBW Insight editors discuss the latest European consumer healthcare industry news. This week, Tom Gallen and David Ridley look at the Q1 financial results of four major Europe-based OTC players - GSK, Sanofi, Bayer and Reckitt - to analyse the impact that the coronavirus is still having on the region's consumer healthcare industry. An almost non-existent cough and cold season, due to lockdown measures, and last year's stockpiling of OTC drugs, have led to double-digit decreases in Q1 sales. A continuing trend for wellness and dietary supplements has offset some of the negative impacts of COVID-19, and, when the cough and cold season returns, points to a bright future for the European OTC market.
Pink Sheet reporters and editors discuss the US FDA decision to lower the eligibility age for the Pfizer/BioNTech COVID-19 vaccine, CMS drug pricing project plans, and mid-stream standard of care changes in drug development.
In this edition of Device Week, Medtech Insight’s Marion Webb discusses AdvaMed’s Medtech Conference Hosted last week, where issues regarding the mesh between medtech and consumer tech were discussed. Reporter Barnaby Pickering talks about a company he recently covered, Cumulus Neuroscience, and its innovative work in clinical trial monitoring.
For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: - When Medtech Meets Consumer Tech It Comes Down To Machine Meets Human - Exec Chat: Cumulus Neuroscience Help Trials Collect Previously Underutilized, Vital Data
The podcast takes a look at the story behind the Pharmaprojects’ Pharma R&D Annual Review 2021
In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.
Pink Sheet reporters and editors discuss the potential for the US and other governments to waive IP protections for COVID-19 vaccines, the FDA’s inspection backlog during the pandemic, and potential reimbursement changes for CAR-T therapies.
Pink Sheet reporters and editors discuss the three-day US FDA advisory committee review of several oncology accelerated approvals, President Biden’s speech to Congress and its impact on drug pricing legislation, as well as the implications of the US helping India battle its COVID-19 surge.
In this week’s podcast, Medtech Insight's Barnaby Pickering features Finnish start-up GlucoModicum, which created a way to measure blood glucose levels without using needles. Managing editor Marion Webb discusses her latest Market Intel, which highlights three companies that developed technologies to help surgeons collaborate with remote surgical experts, including medical device specialists.
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Start-Up Spotlight: GlucoModicum Hopes To Market Disruptive Glucose Monitoring Technology
Market Intel: Medtechs, Surgeons Embrace ‘Virtual Operating Theater’ As New Reality
Smile Train And BioDigital Introduce App To Train Surgeons In Cleft Palate Repair
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
In this week’s podcast, Medtech Insight managing editor Elizabeth Orr discussed the implications for medtech patent law from the US Supreme Court’ Minerva Surgical v. Hologic Inc. case. Ferdous Al-Faruque outlined the USPTO’s efforts to encourage inventors to file for COVID-19 product patents.
Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.
In this week’s podcast, Medtech Insight's managing editor Marion Webb discusses plans by the Mayo Clinic and Veterans Health Administration to position themselves as medical device makers of 3D printing technologies. UK-based reporter Barnaby Pickering gives an overview of the global market for arthroscopy and sports medicine products.
Listen to the podcast via the player below:
https://medtech.pharmaintelligence.informa.com/MT143767/MDM-BIOMEDigital-2021-There-is-No-Easy-Button-On-3D-Printing-Panelist-Says
https://medtech.pharmaintelligence.informa.com/MT143752/Market-Brief-Global-Market-For-Arthroscopy-And-Sports-Medicine-Products-Will-Reach-63Bn-By-2025
https://medtech.pharmaintelligence.informa.com/MT143779/Reimbursement-Dispute-Between-Novitas-And-iRhythm-Hits-An-Impasse
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Medtech Insight articles addressing topics discussed in this episode:
HBW Insight editors discuss the latest European consumer healthcare industry news. This week, Tom Gallen and David Ridley look at some predictions for the future of the UK and European CBD market. Some experts see the market in two or three years dominated by big pharma, and with many products going the OTC medicines route, while others expect CBD firms in the UK to challenge the country's food regulator, the FSA, for what they call its "muddled" approach to bringing order to the already well-established British cannabidiol food supplements market.
In this week’s case study podcast we discuss first-of-their-kind US FDA emergency use authorizations for at-home COVID-19 diagnostics made by Lucira Health and Ellume.
Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.
The FDA’s outgoing second-in-command, Amy Abernethy, is confident she’s leaving the agency in good hands but plans to continue to advocate for patients by focusing on areas such as trial design and use of real-world evidence. In this interview with Medtech Insight, Abernethy also talks about the work she put in to make sure there was a change in IT culture at the agency, among other topics.
In this week’s podcast, Medtech Insight managing editor Reed Miller discusses Augmedics’ and NeuroPace’s financing deals, and UK-based reporter Barnaby Pickering offers some insights from Octopus Ventures, a venture capital fund based in London.
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Medtech Insight articles addressing topics discussed in this episode: Investor Eye: Octopus Ventures Tackles Tough, Taboo Problems In Health Care NeuroPace Seeks $75M In IPO Augmedics Raises $36M To Support Stereotactic Surgical Navigation For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Listen to our experts as they outline the perfect entry for the 2021 OTC Marketing Awards
HBW Insight editors discuss the latest European consumer healthcare industry news. This week, Tom Gallen and David Ridley examine how a growing number of EU member states are allowing prebiotic and probiotic on food supplement labels, despite EFSA regulations; a last minute revision of the UK's CBD regulations, which allow products linked to a novel food application - not necessarily validated - to remain on the market from the end of this month, as well as a group of companies that have all received a pre-validation from the FSA thanks to a consortium-based approach; and finally how GSK is exploring sustainable paper bottles for three of its biggest consumer health brands to advance its ambitious sustainability strategy.
This week’s podcast tackles FDA second-in-command Amy Abernethy’s surprise announcement that she’s leaving the agency. Then, we reveal how an FDA panel thinks dermal fillers like Restylane can be made safer for consumers following a recent uptick in serious adverse events.
Pink Sheet reporters and editors consider the impact of pre-announced domestic inspections, as well as look at the various COVID-19 vaccine safety monitoring programs and new data on application decisions during the pandemic.
In this week’s podcast, Marion Webb reviews her recent conversation with the leader of Edwards Lifesciences’ critical care business and Barnaby Pickering offers a look at the near future of M&A and finance in medtech.
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Medtech Insight articles addressing topics discussed in this episode: Expanding Medicare Coverage For Digital Health Technologies Gains Support http://bit.ly/2P4hGhi
Medtronic CEO Regrets Not Moving More Aggressively On Some M&A Deals During Pandemic http://bit.ly/2OMaFSe
Glooko Raises $30M To Accelerate Commercial Strategy, R&D, Tuck-In Acquisitions http://bit.ly/3lpz5Nr
Pandemic Perspectives: A Lasting Impact On Medtech, But Not Dealmaking http://bit.ly/3rS4Gd3
HBW editors Tom Gallen and David Ridley discuss the big issues in the European consumer health market from the past week. In this edition, they delve into Stada's annual results and US launch plans and Bayer's ambitious sustainability strategy.
In this week’s podcast, we talk about what the most recent COVID-19 relief package might mean for the device industry, including funding for diagnostic development and manufacturing as well as small business loans. There’s also information about a new international standard that urges manufacturers to use laboratory-grown skin instead of animals for irritation testing.
Pink Sheet reporters and editors discuss the impact of the COVID-19 pandemic on pharma and the FDA and consider former commissioners’ pleas for President Biden to nominate a permanent agency commissioner.
In an exclusive interview with Medtech Insight Medtronic CEO Geoff Martha discussed what it has been like not just taking the reins at the start of the pandemic but adjusting the company to meet public need.
HBW Insight editors Tom Gallen and David Ridley discuss the big issues in the European consumer health market from the past week. In this edition, they delve into probiotics, digital health and Bayer’s recent turnaround.
In this week’s podcast, Medtech Insight's managing editor Marion Webb discusses a new monthly digital health roundup which will soon feature on Medtech Insight. Managing editor Reed Miller discusses reimbursement difficulties as it applies to remote cardiac monitoring. UK-based reporter Barnaby Pickering gives an overview of an interview he did with the chief medical officer of Adaptive Biotechnologies about its new T-Detect platform.
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Reimbursement Questions Jeopardize Hillrom/Bardy Merger
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Medtech Insight articles addressing topics discussed in this episode:
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
In this week’s podcast, Medtech Insight's managing editor Marion Webb discusses Guardant Health’s launch of a new liquid biopsy test to detect early-stage colorectal cancer. Deputy editor Reed Miller discusses Canadian-based Neovasc’s recent funding and what it could mean for its Reducer transcatheter technology. UK-based reporter Barnaby Pickering gives an overview of the fast-growing insulin pump market.
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Guardant Health Launches Liquid Biopsy Test For Detecting Colorectal Cancer Recurrence
Market Intel: Rivalry Among Insulin Pump Makers Heats Up With Expected Launches In 2021
Neovasc Maintains Investor Confidence Despite FDA Struggles; Sells $72M In Stock
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Medtech Insight articles addressing topics discussed in this episode:
Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
On this week’s podcast we talk about four hot topics that medtech quality and regulatory professionals should keep a close eye on this year, and discuss an increase in False Claims Act cases in 2020.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Pink Sheet reporters and editor discuss the latest coronavirus vaccine news, CMS’ effect on the future of aducanumab, as well as new assessment goals for PDUFA VII.
This week’s podcast includes an update on the growing trend of “blank check” companies taking medtech companies public, a spotlight on Manus’ pen that can diagnose Parkinson’s disease, and a look at how pandemic is impacting valve replacements.
Medtech Insight articles addressing topics in this episode: Blank Check Companies’ Hunt For Innovative Medtech Start-Ups To Heat Up Further, Experts Predict http://bit.ly/2YIxqIn
Start-Up Spotlight: Manus Neurodynamica Hopes To Write The End Of Traditional Parkinson’s Diagnosis http://bit.ly/3aA7VOP
Edwards Keeps TAVR Going During COVID-19 Surge http://bit.ly/3cIyJiK
MDMA’s Mark Leahey talked with Medtech Insight about how the medical device industry responded to the COVID-19 pandemic, plans for working with a new administration and Congress, and hopes for the MDUFA negotiations.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
On this week’s podcast we talk about 5G cellular technology and the role it could play in the health care industry. We also discuss President Biden’s recent decision to invoke the Defense Production Act and what it means for medtech, and we tell you the names of three people who are on the short list to be the next director of the US Medicare agency CMS. Medtech Insight articles addressing topics discussed in this episode: • Ericsson Is Readying For A 5G Health Care Revolution • AdvaMed: Medtech Industry Wants Seat At Biden’s Coronavirus Response Table • Source: 3 Former Obama US CMS Officials Being Considered To Lead Biden’s Medicare Agency
Pink Sheet reporters and editor discuss Biden’s look at coronavirus dose-sparing strategies, FDA plans for vaccine adjustments in lieu of viral variants, new CMS administrator candidates and groups lobbying for the new FDA commissioner.
Scrip’s preview of the fourth-quarter and full year 2020 earnings calls – Editors Jessica Merrill and Mandy Jackson are joined by Derek Burkhard, head of financial content for Datamonitor Healthcare and Biomedtracker, to discuss current trends for biopharmaceutical companies.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
In this week’s podcast, Medtech Insight's managing editor Marion Webb and deputy editor Reed Miller discuss highlights from the recent J.P. Morgan Healthcare and North American Neuromodulation Society (NANS) virtual meetings. London, UK-based reporter Barnaby Pickering profiles start-up CorWave SA, which developed a left ventricular assist device for treating end-stage heart failure.
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NANS 2021: Nevro’s HF10 Spinal-Cord Stimulator Succeeds In Two Trials
NANS 2021: Boston Scientific Advances New Personalized Pain Therapy
JPM 2021: EY Says Pandemic Leaves Medtech With $500Bn In M&A Firepower
Start-Up Spotlight: CorWave Takes Inspiration From Nature To Tackle Heart Failure
JPM 2021: Conformis Announces ACS Knee For 2H 2021, Integra Weathers Pandemic
JPM 2021: Intuitive Surgical, Accelerate Diagnostics, Siemens Healthineers, Exact Sciences, Renalytix
JPM 2021: Boston Scientific, Abbott, Dexcom, Insulet, Silk Road Medical
JPM 2021: Medtronic, Biogen, Edwards LifeSciences, Guardant Health, Illumina
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Medtech Insight articles addressing topics discussed in this episode:
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
On this week’s podcast we talk about outgoing US FDA chief Stephen Hahn and the role he wants to play beyond 20 January, as an ex-commissioner. We also discuss the US enforcement landscape around COVID-19-related products and how it’s still taking shape. Medtech Insight articles addressing topics discussed in this episode: • FDA Commissioner Hahn To Seek Public Health Leadership Post To Work On COVID-19 Issues Next • Attorneys Expect COVID-19 ‘Enforcement Press’ Centered On PREP Act, Diagnostics
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Pink Sheet reporters and editors discuss the implications of a Democratic Congress for the pharma industry, ongoing problems with slow coronavirus vaccination rates, and the high CDER novel approval count in 2020.
In this week’s podcast, Medtech Insight's deputy editor Reed Miller discusses Stryker’s buy-out of OrthoSensor and the rising importance of biosensor technology in orthopedics. Marion Webb discusses Hologic’s buy-outs of Somatex and BioTheranostics and planned coverage for next week’s J.P. Morgan Healthcare Conference, Digital Medicine & Medtech Showcase, and NANS meeting.
In a podcast interview with Medtech Insight, Hogan Lovells attorneys Mike Heyl and Jodi Scott predict what to expect this year when it comes to US regulation and policy matters.
In an exclusive Q&A with Medtech Insight, Medtronic’s Robert Kowal talks about how COVID-19 has gotten the company to focus on remote capabilities for their cardiac devices, permanently changed its corporate culture and more.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
On this week’s podcast we talk about a recent survey that shows how medical device makers and their sales reps have been impacted by surgical restrictions brought on by the pandemic. Also: a spotlight on Ellume Health’s COVID-19 Home Test.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
In this week’s podcast: LivaNova sells its heart valve business to a private equity firm, an expert panel discusses the challenges of addressing so-called “metabesity,” and Dexcom explains its plans to double its revenue over the next few years.
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Medtech Insight article addressing topics discussed in this episode:
LivaNova Sells Surgical Heart Valve Business To Gyrus Capital For $73M Conquering Metabesity: Expert Panel Discusses Roadmap To Find Solutions Exec Chat: Dexcom CEO Kevin Sayer Talks About Access, Growth, Resiliency During Pandemic
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.
Medtech Insight article addressing topics discussed in this episode:
• Recent eMDR Change By FDA Asks Adverse Event Reporters About Third-Party Servicers https://medtech.pharmaintelligence.informa.com/MT142951/Recent-eMDR-Change-By-FDA-Asks-Adverse-Event-Reporters-About-Third-Party-Servicers
Pink Sheet reporters and editors look at the UK MHRA’s surprising approval of the Pfizer/BioNTech coronavirus vaccine, as well as the US reaction, and discuss President-elect Joe Biden’s potential US FDA commissioner nominees.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Device Week, 19 November 2020 – Glooko Exec Chat; Boston Scientific Kills Lotus TAVR by Informa
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
On this week’s podcast: The US FDA is plotting a pilot program that will allow agency investigators to conduct virtual facility inspections; enforcement experts say pandemic cleanup efforts could last for years; a peek ahead as to how quickly President-elect Joe Biden will fill top roles at the HHS and the FDA; and more. Medtech Insight articles addressing topics discussed in this episode: •FDA Quietly Plots Pilot Program For Virtual Inspections As Pandemic Rages On https://medtech.pharmaintelligence.informa.com/MT143051/FDA-Quietly-Plots-Pilot-Program-For-Virtual-Inspections-As-Pandemic-Rages-On •Enforcement Experts: COVID-19 Backlog Could Last Years https://medtech.pharmaintelligence.informa.com/MT143059/Enforcement-Experts-COVID-19-Backlog-Could-Last-Years •Experts: Biden Will Rush To Fill HHS, FDA Posts; Georgia Senate Races May Decide ACA’s Fate https://medtech.pharmaintelligence.informa.com/MT143054/Experts-Biden-Will-Rush-To-Fill-HHS-FDA-Posts-Georgia-Senate-Races-May-Decide-ACAs-Fate •Attorneys, Insurers Disagree With Manufacturers On Need For Clinical Evidence For MCIT Coverage https://medtech.pharmaintelligence.informa.com/MT143058/Attorneys-Insurers-Disagree-With-Manufacturers-On-Need-For-Clinical-Evidence-For-MCIT-Coverage
Pink Sheet reporters and editor discuss the potential changes at the FDA under President-elect Biden and the take-aways from the negative advisory committee recommendation for Biogen’s proposed Alzheimer’s drug aducanumab.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
In this week’s podcast, Medtech Insight's managing editor Marion Webb discusses how the US Preventive Services Task Force’s recommendations to lower colon screening to age 45 may impact Exact Sciences’ Cologuard stool test. Deputy editor Reed Miller highlights third-quarter results of Stryker, Boston Science and Edwards Lifesciences.
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Stryker Sees ‘V-Shape’ Recovery In Third Quarter
Boston Scientific Exceeds Wall Street’s Expectations In Q3
Edwards Returns To Growth In The Third Quarter
USPSTF Recommendations For Colon Cancer Screening At Age 45 Could Give Cologuard A Boost
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Medtech Insight articles addressing topics discussed in this episode:
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
In this week’s podcast, Medtech Insight's senior reporters Sue Darcey and Ferdous Al-Faruque discuss which political candidates are getting campaign donations from the medtech industry in the 2020 US Senate and House elections, and where the US Food and Drug administration and other stakeholders including the medtech industry stand as the medical device user negotiations get under way.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
In this week’s podcast, Medtech Insight's managing editor Marion Webb has an update from the virtual HLTH panel discussions on telehealth and robotics. Deputy editor Reed Miller discusses trial results from Boston Scientific’s next-generation Accurate neo2 self-expanding aortic valve presented during the Transcatheter Cardiovascular Therapeutics (TCT) meeting.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
HLTH 2020: Panel Finds Pandemic Accelerates Uses For Robots In Health Care, Even ‘Zumba’
HLTH 2020: Amwell CEO Foresees Patient Demand Will Drive Telehealth’s Future
Boston Scientific’s TAVR Pipeline Delayed; FDA Approval Of Accurate neo2 Set For 2024
Pink Sheet reporters and editors discuss their take-aways from the recent advisory committee meeting on coronavirus vaccine development and approval, as well as the upcoming FDA hearing on Makena’s withdrawal.
HBW Insight's David Ridley (Senior Editor, EU) and Tom Gallen (Managing Editor, EU) discuss the current situation with cannabidiol food supplements in Europe, covering the latest moves by the European Commission to classifyfy CBD as a narcotic, as well as the way that individual members states Germany and France have approached the regulation of this popular ingredient. We also get the lowdown from CBD expert Greer Deal - Director, Global Regulatory Services - on what are the key considerations for consumer health companies either already operating in this exciting space, or are thinking about entering the European CBD market.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Following CMS’ recent proposed rule to give immediate national coverage for breakthrough medical devices, Impulse Dynamics’ CEO Simos Kedikoglou spoke with Medtech Insight about what it could mean for companies like his.
On this week’s podcast: The US FDA was busy with draft and final guidance documents this week, issuing three within 24 hours. The docs address disparate device-industry concerns, ranging from of-the-moment issues like coronavirus test supplies, to more traditional concerns around device materials testing. Medtech Insight articles addressing topics discussed in this episode: • Citing Shortages Tied To COVID-19, FDA Allows Some Alternative Flu Test Materials • FDA Proposes Negating Need For Biocompatibility Testing For Certain Materials • FDA Guidance: Sponsors Of Nitinol Devices Must Address Thermomechanical Properties Of Alloy
Pink Sheet reporters and editor discuss the future of coronavirus products with an emergency use authorization, potential pandemic-inspired regulatory changes at the FDA, and preview the agency’s upcoming advisory committee meeting on coronavirus vaccines.
APAC Podcast Episode 4: Vaccines, NASH, Digital Tools, India Q2 And Japan Deals by Informa
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Republican incumbent President Donald Trump and Democratic challenger and former Vice President Joe Biden offer starkly different visions for the future of the country – including the courts system. But for medtech companies, some of the effects on the ground may be muted by the continuing power of Trump’s judicial appointments. Medtech Insight articles addressing topics discussed in this episode: • US Election 2020: Trump’s Sway Over Courts Expected To Linger • Legal Experts Predict How US Supreme Court Shake-Up Will Impact Medtech
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
This episode of the Device Week podcast covers Cognoa’s development of an app to detect autism spectrum disorder early, Novocure’s customer-focused strategy during the pandemic, and the new $585m fund created by Longitude Capital to invest in medtech, pharma and biotech.
Medtech Insight articles addressing topics discussed in this episode:
Cognoa Seeks De Novo Clearance For AI-Powered Diagnostic App For Autism After Successful Study https://bit.ly/2RVDqtU
Novocure Transforms Patient Support System During Pandemic https://bit.ly/2FRAGLO
Pink Sheet Podcast: US FDA Power Plays, Vaccine EUA Without The Sponsor, RBG’s Impact On Pharma by Informa
In the age of coronavirus, human factors professionals are doing their best to find their way through the pandemic by putting unique twists on usability testing to see what works and what doesn’t in the new reality. That’s the topic of this week’s podcast. Medtech Insight articles addressing topics discussed in this episode: • Human Factors Experts Forge Ahead With ‘Tricky’ In-Person Studies In The Age Of Coronavirus
Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Pink Sheet reporters and editor discuss the ramifications of the AstraZeneca vaccine trial hold, and vaccine sponsors pledging to wait until the completion of Phase III before submitting applications, as well as efforts to extend the rare pediatric disease priority review voucher program.
On this week’s podcast we discuss Israeli fetal care start-up Nuvo Group, Grail’s $100m IPO and a new rapid, antigen test from Qiagen.
Medtech Insight articles addressing topics discussed in this episode: https://medtech.pharmaintelligence.informa.com/MT142715/Grail-Files-For-100M-IPO-Plans-To-Launch-MultiCancer-Early-Detection-Test-In-2021 https://medtech.pharmaintelligence.informa.com/MT142709/Qiagen-Ready-To-Rival-Abbott-With-Rapid-Portable-Antigen-COVID19-Test https://medtech.pharmaintelligence.informa.com/MT142690/StartUp-Spotlight-Nuvo-Groups-Remote-Monitoring-Platform-Could-Make-Prenatal-Checks-More-Accessible
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Pink Sheet reporters and editor discuss coronavirus vaccine allocation and prioritization proposals, sponsors submitting before phase III is completed, and a CBER proposal to create a coaching staff for inexperienced gene therapy sponsors.
Pink Sheet reporters and editor discuss coronavirus vaccine allocation and prioritization proposals, sponsors submitting before phase III is completed, and a CBER proposal to create a coaching staff for inexperienced gene therapy sponsors.
On this week’s podcast we talk about a potentially game-changing proposed rule from the US CMS that would provide four-year conditioned coverage for breakthrough medical devices and diagnostics. Medtech Insight articles addressing topics discussed in this episode: https://medtech.pharmaintelligence.informa.com/MT142680/GameChanger-CMS-Proposes-Rule-To-Cover-Breakthrough-Devices-On-Provisional-Basis
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
This week’s podcast includes discussion of Medtronic’s latest sales and earnings report and an update on Freenome’s multiomics liquid biopsy test for early-stage colorectal cancer.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Medtronic ‘Plays Offense’ Despite Pandemic Challenges, Q1 Results Provide Optimism https://bit.ly/3b2c1iB ADA 2020: Medtronic Explains Strategy To Return Growth To Diabetes Business https://bit.ly/3dkyCX4 Freenome Raises $270M In Series C, Accelerates Trial For Colorectal Cancer Test https://bit.ly/32xADfd Freenome Scores $160M In New Funding. So What's Next? https://bit.ly/32zzKCK
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Device Week, 21 August 2020 – Medicare Updates Cardiac Treatment Coverage; FDA Gives Premarket Submission Advice On this week’s podcast we talk about the US Medicare agency’s move to update its coverage for two lifesaving cardiac treatments and tips from FDA on premarket submissions for spinal devices. Medtech Insight articles addressing topics discussed in this episode: • FDA Shares Best Tips To Alleviate Premarket Submission Pain Points: https://medtech.pharmaintelligence.informa.com/MT142607/FDA-Shares-Best-Tips-To-Alleviate-Premarket-Submission-Pain-Points • CMS Updates Medicare Coverage For LVADs, Artificial Hearts: https://medtech.pharmaintelligence.informa.com/MT142591/CMS-Updates-Medicare-Coverage-For-LVADs-Artificial-Hearts
Pink Sheet reporters and editors discuss the surprise complete response letter for a new gene therapy, the specialists who may be added to the FDA’s coronavirus vaccine advisory committee, and look at facility inspections during the pandemic.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Pink Sheet reporters and editor discuss differing views of coronavirus vaccine approval plans from Operation Warp Speed and the FDA, Commissioner Hahn encouraging providers to be confident in agency-approved vaccines and therapeutics, and a study of internal disagreements in FDA drug assessments.
In this week's edition of the Device Week podcast, Medtech Insight managing editor discusses the rapid growth of telehealth services for mental health and Catherine Longworth explains Thermo Fisher is dropping plans to acquire Qiagen.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode: Opportunities For Medtech In Mental Health Qiagen Terminates Thermo Fisher Deal After Shareholders Reject Last Offer Hedge Fund Seeks Higher Price For Qiagen As COVID-19 Boosts Sales
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Pink Sheet reporters and editors dig into the emerging coronavirus vaccine regulatory schedule, look at vaccine purchasing trends, and consider the curious case of a federal government billboard encouraging convalescent plasma donations.
In this Device Week, Ashley Yeo asks PB Consulting managing director Dan Jones about the adjustments needed by UK medtechs as they face a confluence of change brought about by Brexit, COVID-19 and NHS reform, at time when the MHRA has come under increased scrutiny.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
On this week’s podcast we talk about a new study that says medical products companies that include women on their board of directors recall the most problematic of goods weeks faster. Medtech Insight articles addressing topics discussed in this episode: • Want To Make Faster Class I Recall Decisions? Then Put Women In The Boardroom, Study Says
Pink Sheet reporters and editor discuss the start of Phase III coronavirus vaccine trials, FDA’s pandemic work moving away from the idea stage, and the push for a permanent extension of the rare pediatric disease priority review voucher program.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Pink Sheet reporters and editors discuss the performance of the leaders of several coronavirus vaccine manufacturers during a recent congressional hearing and discuss proposed changes to the generic and prescription drug user fee programs.
In this edition of Device Week, Medtech Insight discuss second quarter results from some of medtech’s biggest companies and new guidelines for elective orthopedic surgery to minimize the risk of COVID-19 infection in hospitals.
For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: - Philips Sales Slide In Q2 But COVID-19 Drives Growth In Connected Care: https://bit.ly/2WPSNac - Abbott Sees Signs Of Post-Pandemic Recovery In Q2: https://bit.ly/2EdnHmd - J&J Bullish On Procedure Recovery As Q2 Device Sales Beat Analyst Expectations: https://bit.ly/2OPIKgM - Hip And Knee Surgeons Offer Recommendations For Resuming Elective Surgeries To Reduce Risk Of COVID-19: https://bit.ly/2OPIKgM
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Craft the perfect entry for the 2020 #GGBAwards with our experts in this Entry Guideline Podcast. Entries close on August 14th 2020.
In this Device Week, Medtech Insight’s Amanda Maxwell reviews the EU regulatory outlook for device companies against the backdrop of COVID-19 and consequent delay in the MDR application date, the knock-on effects on the IVDR, and the pressures being felt by notified bodies.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
In this week’s podcast, Medtech Insight's managing editor Marion Webb chats with editor-in-chief Phil Greenfield about start-up Protaryx Medical, which raised $8.3m to develop its first-in-class device for transseptal access to the left atrium. Deputy editor Reed Miller discusses proposed updates by the Centers for Medicare and Medicaid Services for coverage of transcatheter mitral valve repair and reporter Catherine Longworth talks about her Exec Chat with Angelo De Rosa, VP of Boston Scientific’s cardiac rhythm management business about opportunities for digital transformation in health care.
Listen to the podcast via the player below:
CMS Proposes Coverage Policy For Transcatheter Edge-to-Edge Mitral Valve Repair https://bit.ly/3efqac1
Start-Up Spotlight: Protaryx Aims To Simplify Transseptal Access https://bit.ly/2O4AQQ7
Exec Chat: Boston Scientific’s Angelo De Rosa Forsees Digital Transformation In The COVID-19 Era https://bitly.is/31YTIIC
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
With the CPhI Pharma Awards going Digital in 2020, what does that mean for entries? Get an insight into crafting the perfect entry in our latest podcast
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Summary:
This week's Device Week podcast covers recent regulatory developments in Asia in the wake of COVID-19, and how regulators are adjusting to working under the pandemic. Having published two updates from our regular Asian Medtech Associations Reg Networking discussions this week, Medtech Insight speaks to Asia Regulatory Professional Association founder Jack Wong on Asian regulatory themes and South Korea's hosting of the next International Medical Device School.
In this Device Week, we speak to Singapore-based regulatory specialist Jack Wong, founder of the Asia Regulatory Professional Association, and go deeper into the regional Asian themes explored in our twin regulatory updates published this week. ([A#MT142362]) and ([A#MT142364])
The first half of the podcast is a discussion of the benefits – or otherwise – of a move to a virtual working environment for medtech regulatory affairs professionals, and the priorities now and in the future as the incidence COVID-19 continues to be brought under control in the Asian economies. The second half addresses the need for greater awareness and training in the sector generally, and describes the remit and next stages of the new International Medical Device School.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
When might the first COVID-19 vaccine arrive, which companies might get there first, and just how good that vaccine or vaccine needs to be at protecting the world against Sars-COV2? A look at the competitors and the challenges facing them and global healthcare systems. Including an exclusive interview with one of the frontrunners, China’s CanSino Biologics.
Hosted by Andrew McConaghie and Kevin Grogan from the Scrip Pharma Intelligence team
Pink Sheet reporter and editors discuss the lower new drug submission rate in 2020, another EUA for a potential coronavirus treatment, and the biosimilar user fee program missing revenue estimates again.
Join us for an audio catch-up on the latest key developments in the worldwide biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
This week’s Device Week podcast covers the recent American Diabetes Association conference, which was held online for the first time. The major diabetes device makers – Abbott, Medtronic and Dexcom – used the meeting to announce new clinical data and explain their diabetes product pipeline to customers and investors.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
ADA 2020: Abbott Expects CGM To Reduce Insulin Needed For Type 2 Diabetes https://bit.ly/2NbZmOZ
ADA 2020: Medtronic Explains Strategy To Return Growth To Diabetes Business https://bit.ly/3dkyCX4
ADA 2020: Tandem Wins FDA Nod For T:Slim Pump Technology In Children; Positive Feedback on Studies https://bit.ly/2AHtDmh
ADA 2020: CGM Maker Dexcom Gains CE Mark, Launches G6 Pro While Rivalry With Abbott Builds https://bit.ly/2YLiZ5S
Pink Sheet reporter and editor discuss Operation Warp Speed’s manufacturing goals, the US FDA’s decision to pull the hydroxychloroquine EUA, and the race to beat the deadline to remain eligible for a rare pediatric disease priority review voucher.
On this week’s podcast we discuss some recent news out of the US FDA about its efforts to harmonize its Quality System Regulation with international quality systems standard ISO 13485. Medtech Insight articles addressing topics discussed in this episode: Q&A: New Details Emerge From FDA About Long-Delayed Draft Rule That Harmonizes Quality System Reg With ISO 13485 For FDA, The Third Time Wasn’t The Charm For Releasing A Draft Of Its Harmonized Quality System Reg FDA’s Retooled Quality System Regulation Coming ‘Sometime This Year,’ CDRH Chief Shuren Says
Pink Sheet reporters and editor discuss Merck CEO Ken Frazier’s thoughts on racial inequity, US FDA Commissioner Stephen Hahn’s explanation of coronavirus-related decision-making and changes at Operation Warp Speed, as well as consider fears user fee goal delays may be imminent.
In this edition of Device Week, Medtech Insight’s Reed Miller chats to Marion Webb about strategies medtech businesses can take to recover from the COVID-19 pandemic. He also discusses a new $100M Pandemic Innovation Fund created by Israeli crowd investing fund OurCrowd with reporter Catherine Longworth.
For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: • Beyond COVID-19: Industry Insiders Offer 10 Strategies For Medtech Recovery: https://bit.ly/2Xytz0B • Interview: Lessons Learned From The Pandemic And Five Strategies For Medtech Recovery: https://bit.ly/2AEgdXQ • MeMed Ready To Partner On IVD Technology That Can Cut Antibiotic Overuse: https://bit.ly/3dCJ6Ch
In 2018 the US FDA and the Medical Device Innovation Consortium (MDIC) embarked on a mission to recast corrective and preventive action – CAPA – as a continuous learning tool, rather than a place where problems often go to linger, be ignored and never die. On this week’s podcast we talk about the latest in those efforts, including a pilot program that’s testing a risk-based CAPA framework. Medtech Insight articles addressing topics discussed in this episode: • Not Your Grandfather’s CAPA: Case For Quality Pilot Gives Corrective And Preventive Action A Facelift • How A Team Led By Medtronic Quality Experts Plans To Stand Up To 'A Monster Called CAPA' – And Make It 'Cool'
On this week’s podcast we talk about steps the agency is taking to begin conducting in-person surveillance audits again in the US. Medtech Insight articles addressing topics discussed in this episode: • When Will FDA Inspections Resume? Agency Looks To CDC, White House For Guidance • No Firings, No Furloughs: FDA Staff Weathering COVID-19 Pandemic
In this week’s podcast, Medtech Insight's deputy editor Reed Miller highlights trial results from Boston Scientific and Medtronic at HRS 2020. Marion Webb discusses the impact of COVID-19 on Q1 2020 earnings results of major orthopedics companies.
Pink Sheet reporter and editor discuss the virtual appearances by US FDA Commissioner Stephen Hahn and others on Capitol Hill, GOP right-to-try questions for former BARDA Director Rick Bright, and new BIO CEO Michelle McMurry-Heath.
On this week’s podcast we talk about further steps the US Medicare agency CMS is taking when it comes to expanding testing for COVID-19. We also discuss how the pandemic is wreaking havoc on planned meetings by the US FDA and industry groups. Medtech Insight articles addressing topics discussed in this episode: https://medtech.pharmaintelligence.informa.com/MT126702/CMS-Expands-Coronavirus-Testing-By-Allowing-NonPhysicians-To-Order-The-Diagnostics https://medtech.pharmaintelligence.informa.com/MT126592/CMS-Doubles-Up-On-Test-Reimbursements-Will-Pay-Labs-100-Per-Test-For-COVID19-Clinical-Diagnostic-Ass https://medtech.pharmaintelligence.informa.com/MT126648/Latest-Coronavirus-Bill-Passage-Adds-$100Bn-To-National-Testing-Effort https://medtech.pharmaintelligence.informa.com/MT126602/MDUFA-Meeting-Postponed-Again-Due-To-COVID19-This-Time-Indefinitely https://medtech.pharmaintelligence.informa.com/MT126679/No-End-In-Sight-FDA-Postpones-Another-InPerson-Meeting-Due-To-COVID19 https://medtech.pharmaintelligence.informa.com/MT126613/AdvaMed-CEO-Says-Some-Top-Agenda-Items-For-the-Year-Are-Taking-A-Back-Seat-To-Address-COVID19
Pink Sheet reporters and editor discuss the potential trade-offs associated with speedy coronavirus vaccine development, changes in FDA approval volume since mass-teleworking began, and a study showing the Part D donut hole fix is not keeping up with price increases.
In this edition of the Device Week podcast, Medtech Insight’s Marion Webb and Reed Miller discuss how Edwards Lifesciences is handling the postponement of most transcatheter aortic valve replacement procedures during the pandemic and how it is planning to help customers complete these procedures by the end of 2020.
Medtech Insight articles addressed in this episode:
Edwards Sees ‘Tough Time’ Ahead For TAVR Patients https://bit.ly/3cZk0fZ Wall Street Tries To Guess The Impact Of Pandemic On Medtech Revenues https://bit.ly/2UwqbAQ UK Court Blocks Edwards’ TAVR Device For Patent Infringement https://bit.ly/2y3CCNk
Gilead is set to release pivotal data for its antiviral remdesivir. But will the drug really play a decisive role against coronavirus? Plus an interview with Carl Hansen, CEO of AbCellera, one of several companies racing to find an antibody drug which could provide ‘passive immunity’ against coronavirus while we await a vaccine. Plus analysis of the first quarter impact of the pandemic on biopharma business, and reasons to be cheerful during the lockdown. Hosted by Andrew McConaghie, Sarah Karlin-Smith and Kevin Grogan from the Scrip Pharma Intelligence team in the UK and Beijing.
Pink Sheet reporters and editors discuss the ramifications of Rick Bright’s removal as head of BARDA, government efforts to help prevent coronavirus-related drug shortages, and a proposed preferred specialty tier for Medicare Part D.
On this week’s podcast we highlight the development and US FDA regulation of serology tests for the novel coronavirus. Medtech Insight articles addressing topics discussed in this episode: • COVID-19: FDA Anticipates Further Serology Test Development • COVID-19: FDA Warns Of Potential Risks Of Antibody Tests • Senate Passes Fourth COVID-19 Spending Package, Includes $25Bn For Additional Testing, Contact Tracing
Medtech Insight chatted with AdvaMed CEO Scott Whitaker about how the lobby group is continuing to operate during the COVID-19 pandemic and shifting its priorities to address industry needs.
In this edition of Device Week, Medtech Insight’s Catherine Longworth chats to Reed Miller about how Johnson & Johnson’s medical device business has been impacted by COVID-19 in Q1. She also discusses with Marion Webb Abbott and Dexcom’s permission by US FDA to bring their CGM’s into hospital settings to monitor COVID-19 patients. For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
https://medtech.pharmaintelligence.informa.com/MT126594/JJ-Remains-Optimistic-Despite-5-Decline-In-FirstQuarter-Device-Sales
https://medtech.pharmaintelligence.informa.com/MT126586/New-Frontier-COVID19-Crisis-Opens-Door-For-Dexcom-Abbott-To-Bring-CGMs-Into-Hospitals-For-First-Time
Pink Sheet reporters and editor discuss the potential effects of virtual advisory committees, should they be scheduled, as well as the coronavirus implications of the new first generic for Proventil HFA, and the FDA getting pulled into a Zofran product liability suit.
On this week’s podcast we put the spotlight on two former US Food and Drug Administration officials who say they’re worried about product problems down the line as the agency pauses inspections, auto manufacturers make medical ventilators and device companies quickly scale up manufacturing on items like personal protective equipment. Medtech Insight articles addressing topics discussed in this episode: ‘Have Some Level Of Fear’: How Scrapped FDA Inspections, Hastily Made Ventilators Could Portend Product Problems https://medtech.pharmaintelligence.informa.com/MT126463/Have-Some-Level-Of-Fear-How-Scrapped-FDA-Inspections-Hastily-Made-Ventilators-Could-Portend-Product
In this edition of the Device Week podcast, Medtech Insight managing editor Marion Webb discusses LifeSignals’ plans for a vital-sign monitoring patch that could help remotely monitor patients during the pandemic. Deputy editor Reed Miller highlights some important device trials presented at the American College of Cardiology online conference.
Pink Sheet reporters and editors discuss the lingering questions surrounding the emergency use authorization of chloroquine and the FDA’s new program to speed therapeutic development for coronavirus, as well as break down the agency decision to not sanction Novartis over its Zolgensma data integrity problems.
A special edition focused on biopharma and the coronavirus pandemic. Taking a look at the coronavirus pipeline, including Gilead’s remdesivir ‘The People’s Hope’; has China beaten COVID-19? Plus the long-term impact on pharma R&D and commercial operations. Hosted by Andrew McConaghie, Brian Yang and Kevin Grogan from the Scrip Pharma Intelligence team in the UK and Beijing.
Pink Sheet editor and reports discuss pharma’s wins in the latest coronavirus stimulus bill, explain Gilead’s decision to pull the remdesivir orphan designation, and consider Teva’s suit to force Copaxone’s transition to regulation as a biologic.
Pink Sheet editor and reporters unpack the White House’s confusing coronavirus treatment announcement, and celebrate the arrival of the biologics transition, an important day for pharma.
In this episode of our weekly podcast, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about her story on US hospitals cancelling elective surgeries to preserve critical resources in response to COVID-19 and joining forces with medtechs to find rapid technological solutions to keep patients and caregivers healthy.
Listen to the podcast via the player below:
US Hospitals Cancel Elective Surgeries; Team Up With Medtechs To Find Remote-Monitoring Solutions https://medtech.pharmaintelligence.informa.com/MT126406/US-Hospitals-Cancel-Elective-Surgeries-Team-Up-With-Medtechs-To-Find-RemoteMonitoring-Solutions
Former FDA Chief Urges Manufacturers To Shift Gears In Coronavirus Efforts https://medtech.pharmaintelligence.informa.com/MT126396/Former-FDA-Chief-Urges-Manufacturers-To-Shift-Gears-In-Coronavirus-Efforts
COVID-19: FDA Expands Overseas Inspections Freeze Through April https://medtech.pharmaintelligence.informa.com/MT126388/COVID19-FDA-Expands-Overseas-Inspections-Freeze-Through-April
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
In this edition of Device Week, the weekly podcast from Medtech Insight; senior reporters Ferdous Al-Faruque, Sue Darcey and Elizabeth Orr discuss the federal government’s response to the coronavirus crisis and who will pay for COVID-19 tests; and how the Medical Device Innovation Consortium’s work on Case for Quality is progressing.
Pink Sheet reporter and editor discuss the implications of the FDA decision to cancel meetings and postpone inspections, as well as its new Type 2 Diabetes drug development guidance.
In this edition of Device Week, the weekly podcast from Medtech Insight, managing editor Marion Webb discusses the growing market for robotic-assisted surgery systems and reporter Catherine Longworth provides an update on how medical device companies are responding to the COVID-19 outbreak.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
• Market Intel: Medtech Giants Ready To Battle Frontrunner Intuitive Surgical In 'Soft Surgery Robotics' • Market Brief: Robotic Surgery Systems Market Will Reach $9.7Bn By 2023; Driven By Innovation, Procedure Volume Growth And Access To Emerging Markets • The Cost Of Coronavirus: Medtech Market Wins And Losses • Fact File: Coronavirus Pipeline And Corporate Updates
Pink Sheet reporter and editor give an update on the latest coronavirus news and how it relates to pharma, as well as describe the impact changing one word in a guidance will have on the upcoming biologics transition process.
Jeff Shuren discussed CDRH’s recent successes and his plans for the remainder of 2020, including priorities for upcoming MDUFA negotiations, in an exclusive interview with Medtech Insight. Check out our podcast or read the transcript.
On this week’s podcast, executive editor Shawn M. Schmitt shares expert tips and advice on how device makers can integrate the recently revised international risk management standard ISO 14971 into their quality systems. Medtech Insight articles addressing topics discussed in this episode: • Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971 • Crosswalk: ISO 14971:2007 Vs. ISO 14971:2019
MDMA's Mark Leahey talked with Medtech Insight about repealing the medical device tax, some successes on the reimbursement front and the issues that lie ahead for the medical device industry over the coming year including the upcoming MDUFA negotiations.
Hosted by Andrew McConaghie, Brian Yang and Kevin Grogan from the Scrip Pharma Intelligence team in London and Beijing. Topics covered include what life is really like in China coping with the coronavirus outbreak, Novartis’ groundbreaking work with the NHS in England on its heart disease treatment inclisiran, and the future of Alzheimer’s treatment, including the impending file of Biogen’s aducanumab.
With less than one hundred days left before the European Union Medical Device Regulations kick in, Medtech Insight Executive Editor Ashley Yeo and Managing Editor Amanda Maxwell discuss the growing concern in the medtech industry they may not be ready in time and may inadvertently go afoul of the new regulations.
In this edition of Device Week, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about his recent story on Abiomed's plan to counter unfavorable study outcomes of its Impella heart pump.
Medtech Insight articles addressing topics discussed in this episode:
AbioMed Launches Plan To Counter Unfavorable Impella Data https://medtech.pharmaintelligence.informa.com/MT126227/Abiomed-Launches-$100M-Plan-To-Counter-Unfavorable-Impella-Data
Start-Up Spotlight: BioIntelliSense Launches New FDA-Cleared BioSticker For Remote Monitoring Of Patients' Vital Signs https://medtech.pharmaintelligence.informa.com/MT126231/StartUp-Spotlight-BioIntelliSense-Launches-New-FDACleared-BioSticker-For-Remote-Monitoring-Of-Patien
Knees Boost Zimmer Biomet; Turnaround Continues, But FDA Woes Linger https://medtech.pharmaintelligence.informa.com/MT126216/Knees-Boost-Zimmer-Biomet-Turnaround-Continues-But-FDA-Woes-Linger
Boston Scientific Expects Up to $40M Impact In Q1 From Coronavirus Outbreak; 10%-12% Revenue Increase For 2020 https://medtech.pharmaintelligence.informa.com/MT126214/Boston-Scientific-Expects-Up-To-40M-Impact-In-Q1-From-Coronavirus-Outbreak-1012-Revenue-Increase-For
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As the UK Brexited from the EU on 31 January not much has changed and perhaps much won't change structurally according to Medtech Insight reporter Ashley Yeo but the 11 month negotiations are just getting started between the EU and the UK in terms of how jurisdiction issues will be resolved.
In this edition of Device Week, Medtech Insight’s Catherine Longworth chats to Reed Miller about fourth-quarter 2019 sales and earnings reports coming in from the big medical device companies. She discusses with Reed the findings of a new innovation report published by the UK Medical Technology Group. For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
New Report Calls For UK NHS To Provide Early Access To Medtech https://bit.ly/2UfZuSu
UK Readies Medtech And Pharma Sectors For Regulatory Life Outside The EU http://bit.ly/36Ekg0t
J&J Has Big Plans For Robotic Surgery In 2020 http://bit.ly/2O9WfYV
J&J Takes Full Ownership Of Verb Surgical, Verily Breaks Off Robotics Partnership http://bit.ly/2tnKZAA
Philips Delivers On Aim To Focus Exclusively On Health And Healthtech http://bit.ly/36EJJ9U
US-China Trade War Hits Philips Connected Care Biz In Q3 http://bit.ly/37DU9YS
In a lengthy exclusive with Medtech Insight, chief of the largest medtech lobby group talked about how they won repealing the medical device excise tax and what’s on the plate for 2020 including reimbursement challenges, negotiating with key governments, ethylene oxide regulation and more.
On this week’s podcast, senior reporter Elizabeth Orr highlights the most exciting medical device technology coming down the pike as part of the US FDA’s Breakthrough Devices Program.
In this edition of Device Week, Medtech Insight's Marion Webb discusses her experiences at the recent Consumer Electronics Show in Las Vegas, including her interview with Amy Abernethy, the US Food and Drug Administration's principal deputy commissioner. Deputy editor Reed Miller discusses a recent study from the University of Michigan that suggests the growth of robotic-assisted surgery may be outpacing the evidence to support that technology.
The US FDA oncology chief celebrates his 20th year at the agency with a wide-ranging podcast interview in which he addresses the next two phases of the Oncology Center of Excellence, the new “Project Avatar” and whether advisory committees still give good advice
On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporters Danny Al-Faruque and Sue Darcey about specific pieces of legislation that are expected to pass through the US Congress in the new year and how they’ll impact the medical device sector. Medtech Insight articles addressing topics discussed in this episode: • How A Pro-Software Patent Bill Could Affect The Medtech Industry • 2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight
Pink Sheet reporters recap the biggest pharma regulatory stories of 2019 and their impact on 2020, including the government shutdown, the FDA commissioner carousel and the Zolgensma data manipulation scandal.
In this edition of Device Week, Medtech Insight's deputy editor Reed Miller chats with managing editor Marion Webb about the most popular Market Intel stories in 2019 and next-generation insulin pumps expected to be introduced in 2020.
Hosted by Andrew McConaghie and Alex Shimmings from the Scrip Pharma Intelligence team in London. Andrew and Alex review their pick of the best biopharma and healthcare books of 2019, with contributions from special guests John Hawkins and Mike Rea.
Senior Medtech Insight reporters discuss the new appropriations bill on the president's desk that would repeal the medical device tax, add funding for US FDA and authorize the LAB Act.
In this their first podcast, the Asia content team from Scrip and the Pink Sheet talk about recent developments in their respective regional markets including an Alzheimer’s drug in China, the Indian diabetes and NASH markets, a big approval for a Korean firm, and major M&A deals in Japan.
Karen Currie and Doro Shin discuss the Citeline Awards which recognize outstanding achievements in pharma R&D across a wide range of drug development activities.
This podcast includes tips on how to create a good entry and the judging process.
In this edition of Device Week, Medtech Insight's deputy editor Reed Miller chats with managing editor Marion Webb about her latest in-depth Market Intel story, the first part of a two-part series on the competitive landscape of the global insulin pump market.
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Market Intel: After A Year Of Partnerships, Insulin Pump Manufacturers Will Face Fierce Competition In 2020 https://medtech.pharmaintelligence.informa.com/MT125985/Market-Intel-After-A-Year-Of-Partnerships-Insulin-Pump-Manufacturers-Will-Face-Fierce-Competition-In
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Over the past year a number of medical device sterilization facilities that use ethylene oxide, or EtO, have shut down as US state regulators have raised concerns about their potential environmental impact. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Danny Al-Faruque about what’s happened to date, as well as where this EtO issue is headed in the future. Medtech Insight articles addressing topics discussed in this episode: • Risk Of Sterilization Plant Shutdowns Across US Sends Shockwave Through Industry https://medtech.pharmaintelligence.informa.com/MT125844/Risk-Of-Sterilization-Plant-Shutdowns-Across-US-Sends-Shockwave-Through-Industry • US FDA Experts Caution Against Banning EtO, Encourage More Duodenoscope Training https://medtech.pharmaintelligence.informa.com/MT125882/US-FDA-Experts-Caution-Against-Banning-EtO-Encourage-More-Duodenoscope-Training • Listen: Medtronic Exec Highlights Ethylene Oxide Standards At First Day Of FDA EtO Meeting https://medtech.pharmaintelligence.informa.com/MT125874/Listen-Medtronic-Exec-Highlights-Ethylene-Oxide-Standards-At-First-Day-Of-FDA-EtO-Meeting • Teleflex Says It Will Lose $9m – And Maybe More – Due To EtO Plant Shutdown https://medtech.pharmaintelligence.informa.com/MT125869/Teleflex-Says-It-Will-Lose-$9m--And-Maybe-More--Due-To-EtO-Plant-Shutdown
Hosted by the Scrip Pharma Intelligence team in London. Looking at Novartis’ acquisition of The Medicines Company; are there secret UK-US trade talks on medicines; Highlights from the Jefferies Healthcare investor conference.
In this edition of Device Week, Medtech Insight’s Catherine Longworth chats to Reed Miller about the big clinical trial news from the American Heart Association meeting held in Philadelphia and provides an investor update from the Jefferies Healthcare Conference in London.
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Enforcement of the False Claims Act is always a hot-button topic for industry. That’s because fines for FCA violations can be costly, reaching into the billions of dollars. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Elizabeth Orr about some of the more important FCA cases from 2019. Medtech Insight articles addressing topics discussed in this episode: • FCA 2019: Key Issues Include DOJ Dismissal, Statute Of Limitations • Neurosurgeon, PODs Subject Of DOJ Spinal Device Probe
Pink Sheet reporters discuss the key takeaways from Stephen Hahn's confirmation hearing to become FDA commissioner, as well as a few items from the Fall 2019 regulatory agenda.
Pink Sheet reporters preview the Stephen Hahn confirmation hearing for the FDA commissioner role, and also look at the revocation of buprenorphine's orphan drug designation and Rick Pazdur's comments on Project Orbis.
In this edition of Device Week, Medtech Insight managing editor Marion Webb summarizes her interviews with Ted Tanner, the CTO of IBM Watson Health, and Catherine Mohr, president of the Intuitive Foundation. Both executives addressed the Exponential Medicine conference in San Diego about the future of global medtech. Deputy Editor Reed Miller discusses the appointment of Robert Ford as the new CEO of Abbott Laboratories, the latest in a recent series of high-profile CEO appointments in medtech.
Medtech Insight articles addressing topics discussed in this episode:
Exec Chat: XMed2019: How IBM Watson Health's CTO Uses Blockchain To Eliminate 'Friction Points' In Health Care http://bit.ly/2qdmnJv
Exec Chat: XMed 2019: Intuitive Foundation's President Catherine Mohr's Team Jackets Read 'Plan For 100 Years' http://bit.ly/2qR4aBq
Medtech Veteran Robert Ford Will Take Over As Abbott CEO From Miles White http://bit.ly/2qcCZks
Medtronic CEO Omar Ishrak Announces Retirement; Geoff Martha Will Be New CEO http://bit.ly/2CLuXBM
BD Names COO Thomas Polen As Next CEO; Vince Forlenza Will Retire In January http://bit.ly/32NyPwX
FDA's Suzanne Schwartz discusses her take on a recent advisory committee meeting to discuss ethylene oxide sterilization and duodenoscope infections.
Device Week, 8 November 2019 – Medicare Rules! Some exciting changes to US Medicare payment rules will take effect in January for device-related procedures performed in different hospital settings. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Sue Darcey, who covered these changes for Medtech Insight – as well news out of the Centers for Medicare and Medicaid Services (CMS) that it designated several new medical technologies for passthrough payments and will offer new home-use infusion therapy benefits. Medtech Insight articles addressing topics discussed in this episode: • Final 2020 CMS Outpatient, ASC Payment Rules Broaden Patient Access To Medtech (https://medtech.pharmaintelligence.informa.com/MT125873/Final-2020-CMS-Outpatient-ASC-Payment-Rules-Broaden-Patient-Access-To-Medtech) • CMS Releases Final 2020 Home-Health Rule On Payments For Home Infusion-Therapy Equipment (https://medtech.pharmaintelligence.informa.com/MT125866/CMS-Releases-Final-2020-HomeHealth-Rule-On-Payments-For-Home-InfusionTherapy-Equipment)
The top executive overseeing sterilization issues at Medtronic talked about the importance of developing new ethylene oxide cleaning standards during the first day of a two-day FDA hosted meeting to discuss ideas to mitigate potential medical device shortages due to EtO plants being shut down by state regulators. Phil Cogdill sat down with Medtech Insight to elaborate on the issue and gave his perspective of what he learned from the first days discussions.
In this edition of Device Week, Medtech Insight’s Reed Miller chats to Marion Webb about the future of voice assistant technologies within healthcare and Edwards Q3 results which were driven by demand for its TAVR technology.
Medtech Insight articles addressing topics discussed in this episode: (list relevant stories with bullets, and supply Bit.ly links):
Market Intel: Meet The New Voice In Health Care: Alexa Is Empowering Patients, Doctors http://bit.ly/2JEknR1
LifePod Debuts 'Proactive' Voice Assistant Designed To Ease Elder Care http://bit.ly/2puv01Y
Edwards Invests In Mitral, Tricuspid Solutions As TAVR Growth Exceeds Expectations http://bit.ly/2PBiybw
Diabetes, Mitral Repair And Diagnostics Drive Big Quarter For Abbott http://bit.ly/2r1gbV3
Pink Sheet reporters discuss the implications from recent US FDA advisory committee meetings for Agile's contraceptive patch Twirla and AMAG’s preterm birth drug Makena.
In this edition of Device Week, Medtech Insight senior reporter Ferdous Al-Faruque chats with senior reporters Sue Darcey and Elizabeth Orr about changes to the Anti-Kickback Statutes and the Stark Law, and what that means for the medical device industry as well as the legal community.
Scrip journalists Andrew McConaghie and Kevin Grogan discuss the rise and fall of British fund manager Neil Woodford, the increase in rare disease transactions across the biopharma sector, as well as the ups and downs of Brexit, and what it means for the life science industry.
In this edition of Device Week, Medtech Insight's managing editor Marion Webb chats with deputy editor Reed Miller about the most recent earnings report from Johnson & Johnson and with London-based Catherine Longworth about her upcoming "taboo" tech coverage from the 2019 Global Innovation and New Technology Health Event (GIANT).
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J&J’s Investment In Medical Device Businesses Is Starting To Pay Off http://bit.ly/31oXkQe https://medtech.pharmaintelligence.informa.com/MT125771/JJs-Investment-In-Medical-Device-Businesses-Is-Starting-To-Pay-Off
Ethicon Expects Powered Circular Stapler To Address A Common Source Of Cancer Surgery Complications http://bit.ly/2OY8mJt https://medtech.pharmaintelligence.informa.com/MT125758/Ethicon-Expects-Powered-Circular-Stapler-To-Address-A-Common-Source-Of-Cancer-Surgery-Complications
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Medtech Insight articles addressing topics discussed in this episode:
Get the most out of your entry into the 2020 OTC Marketing Awards with our latest podcast. Listen to find out more about the categories and how to enter.
On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information. Medtech Insight articles addressing topics discussed in this episode: • 'SoomSafety': How A Real-Life Recall Scare Led A Father To Develop A Free App That Gives Detailed Device Safety Info https://medtech.pharmaintelligence.informa.com/MT125732/SoomSafety-How-A-RealLife-Recall-Scare-Led-A-Father-To-Develop-A-Free-App-That-Gives-Detailed-Device • ‘Big Data’ Poses New Product Recall Challenges, FDA Official Says https://medtech.pharmaintelligence.informa.com/MT125649/Big-Data-Poses-New-Product-Recall-Challenges-FDA-Official-Says • Compliance Corner: FDA Officials Share Tips To Ensure A Smooth Recall https://medtech.pharmaintelligence.informa.com/MT125748/Compliance-Corner-FDA-Officials-Share-Tips-To-Ensure-A-Smooth-Recall
In this edition of Device Week, reporter Catherine Longworth provides an update on how Demant Group is recovering from a ransomware attack that forced the Danish hearing aid manufacturer to shut down its IT systems. Deputy editor Reed Miller reviews the highlights from the clinical trial presentations at the recent Transcatheter Cardiovascular Therapeutics conference in San Francisco.
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Medtech Insight articles addressing topics discussed in this episode:
Market Intel: Hearing-Aid Companies' Use Of AI, Apps, New Tech Excites Audiologists; Global Hearing-Aid Market Will Reach $11Bn By 2023 http://bit.ly/2McmTyt
TCT 2019: Boston Scientific's Acurate Neo TAVR Misses Endpoint In SCOPE I http://bit.ly/2Ovf61B
TCT 2019: New COAPT Results Support, Durability And Cost-Effectiveness Of Abbott’s MitraClip http://bit.ly/2pnjDIV
TCT 2019: IDEAL LM Inconclusive, While Onyx ONE Boosts Polymer-Based DES http://bit.ly/2nm1QkC
TCT 2019: Evolve Short DAPT And Model U-SUS Study Show Short DAPT Was Comparable To Longer-Term DAPT http://bit.ly/2LJXNb3
TCT 2019: Five-Year PARTNER 2A Results Support TAVR In Most Intermediate Risk Patients http://bit.ly/2MhYZS0
TCT 2019: TRILUMINATE Six-Month Results Support Abbott’s TriClip http://bit.ly/3317Azi
TCT 2019: One-Year PARTNER 3 Outcomes Show Better Quality Of Life With TAVR http://bit.ly/35a6V0b
Pink Sheet reporters discuss the potential withdrawal of Makena’s accelerated approval, CDER director Janet Woodcock’s remarks on the development of biobetters and the advisory committee meeting on the neuropsychiatric events safety risk for Merck’s Singulair.
The US FDA has been furiously releasing a boatload of updated, draft and new guidance documents over the past month. On this week’s podcast, we discuss three of them, related to clinical decision support (CDS) software, Humanitarian Use Devices (HUD) and Humanitarian Device Exemption (HDE). Medtech Insight articles addressing topics discussed in this episode: • Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances • New FDA Guidance Expands HUD Patient Limit • Final Guidance Clarifies HDE Process, ‘Probable Benefit’
Pink Sheet reporters discuss the US FDA's launch of its Project Orbis collaboration, the agency's call for comments on the development of abuse-deterrent formulations for central nervous system stimulants and the new Rare Disease Cures Accelerator.
Device Week, Sept. 20, 2019 – Medtech Giants Sign Major Diabetes Partnerships by Informa
In this week’s Medtech Insight podcast, senior reporter Elizabeth Orr gives the skinny on the latest developments surrounding the National Evaluation System for health Technology Coordinating Center, or NESTcc. Medtech Insight article addressing topics discussed in this episode: • NESTcc Updates On Projects, Prepares For Winter Launch https://medtech.pharmaintelligence.informa.com/MT125627/NESTcc-Updates-On-Projects-Prepares-For-Winter-Launch
DLA Piper’s Danny Tobey recently spoke with Medtech Insight about how patient privacy regulations under HIPAA may impact medtech products that use AI technology. He notes depending on the case, some companies may need to comply with HIPAA for one business division but not another based on how they are set up.
Pink Sheet Reporters discuss Purdue Pharma's pending settlement on the opioid crisis, the FDA's review of future opioid applications and a proposal to better describe rare disease flexibility.
In this edition of Device Week, Medtech Insight's deputy editor Reed Miller chats with managing editor Marion Webb about her digital health coverage at the recent Connected Health Summit in San Diego. And London, UK-based senior reporter Catherine Longworth talks about her visit with Intuitive Surgical at their new training suite in Oxford.
Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Smart Homes, AI-Assisted Devices, Home Security – Connected Health Summit Puts Spotlight On Independent Living http://bit.ly/2k59gHl
Intuitive Surgical Opens New UK/Ireland HQ In Oxfordshire http://bit.ly/2k593Uz
Assessing The Future Of Robotics In Medtech http://bit.ly/2k5ztWc
International Demand For Robotic Surgery Drives Intuitive Surgical’s Revenues Up 21% in Q2 http://bit.ly/2m2viuU
Connected Health Summit: VCs Discuss Digital Health Investment https://bit.ly/2kmStzL
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Pink Sheet reporters discuss Acting FDA Commissioner Norman Sharpless' future, his comments on the Zolgensma data manipulation scandal, and a setback in Mylan's efforts to move a follow-on insulin application.
Pink Sheet reporters discuss Ed Cox's departure from the FDA to Regeneron, Johnson & Johnson's defeat in an opioid lawsuit and industry comments on the FDA's proposal to release clinical study reports.
In this week’s Medtech Insight podcast, executive editor Shawn M. Schmitt explains how an ongoing "Quality as a Career" initiative from the Medical Device Innovation Consortium (MDIC) is aiming to train the next generation of QA experts. Medtech Insight articles addressing topics discussed in this episode: • Quality Desert: How An Academic Minor In Quality Could Be The Key To Quenching Industry's Thirst For QA Professionals • Device Firms Struggle To Find Qualified Quality Assurance Professionals
Pink Sheet reporters discuss the complete response letter for Sarepta's Duchenne muscular dystrophy drug golodirsen, the Trump administration's appeal of the DTC list price court ruling and the new Business Roundtable statement of purpose.
Pink Sheet reporters assess the implications of the Zolgensma data manipulation announcement, ICER’s findings on the net health benefits of DMD drugs, and the LPAD approval of Pretomanid.
In this edition of Device Week, Medtech Insight managing editor Marion Webb reports on her discussions with diagnostic company executives at the recent American Association for Clinical Chemistry meeting in Anaheim. Senior reporter Catherine Longworth previews her feature on MDisrupt, a new company that touts itself as the world’s first medical diligence company for the healthcare industry.
Medtech Insight articles discussing topics discussed in this episode: Exec Chat: Deepak Nath, President Of Siemens Healthineers' Laboratory Diagnostics, Offers An Insider's Look At AACC 2019 Survey Suggests 'New Normal' In Securities Suits Against Life Sciences Firms Theranos' Holmes, Balwani Slammed By SEC For 'Massive Fraud'
Medtech Insight senior reporters discuss the latest safety concerns over cardiac devices such as drug-eluting stents and implantable cardioverter defibrillators. They also cha about the agency’s recently released user fee rates and how they’ve increased historically.
Pink Sheet reporters ask critical questions about the new drug importation framework and assess the FY 2020 US FDA user fee rates.
In this edition of Device Week, Medtech Insight’s Catherine Longworth chats to Marion Webb about the growth of the global hearing aid market which is set to rise from $7.7bn in 2018 to $11bn by 2023. She also speaks to Reed Miller to discuss Zimmer Biomet’s second quarter results and its long-term plan to return to steady growth. For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: Market Intel: Hearing-Aid Companies' Use Of AI, Apps, New Tech Excites Audiologists; Global Hearing-Aid Market Will Reach $11Bn By 2023: https://medtech.pharmaintelligence.informa.com/MT125413/Market-Intel-HearingAid-Companies-Use-Of-AI-Apps-New-Tech-Excites-Audiologists-Global-HearingAid-Mar Zimmer Biomet Continues Turnaround Lead by ROSA Robot: https://medtech.pharmaintelligence.informa.com/MT125441/Zimmer-Biomet-Continues-Turnaround-Lead-by-ROSA-Robot
Zach Rothstein, the top AdvaMed lobbyist tasked with supporting the medical device industry’s interests in artificial intelligence and machine learning, talked to Medtech Insight about how FDA should regulate the fast-growing sector. He argues there likely won’t be a guidance on AI/ML for at least a year and even then the agency may need new congressional authorities for the guidance to come into effect.
No one likes unhappy surprises, especially when it comes to medical billing. In this week's Medtech Insight podcast, executive editor Shawn M. Schmitt and senior reporter Sue Darcey talk about so-called surprise billing by hospitals and other health-care facilities, how legislation wending its way through Congress is aiming to curb it, and why the medtech industry should care. Medtech Insight articles addressing topics discussed in this episode: • US Senate Sponsors Push Back Vote On Balanced Billing Legislation To Autumn • New US State And Proposed Federal Laws Would Stop Specialists From Balance Billing
In this edition of Device Week, Medtech Insight's managing editor Marion Webb chats with deputy editor Reed Miller about recent earning reports from medtech giants Johnson & Johnson and Abbott.
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Medtech Insight articles addressing topics discussed in this episode:
Johnson & Johnson Growth Led By Biosense Webster and Cerenovus
Abbott Delivers Strong Q2 Sales, Led By Spike In FreeStyle Libre Sales
Global Device Approvals Snapshot: 9-15 July 2019; MitraClip G4, Relievion, RAPID Imaging, ExAblate Neuro
Thinking of nominating yourself, a colleague, your company, or your team for an award this year but not sure where to start? We’ve prepared a podcast just for you with tips on putting together your entry as well as an overview of the CPhI Awards 2019.
In this edition of Device Week, Medtech Insight’s Marion Webb reviews her interview with Omron Healthcare CEO Ranndy Kellogg at the recent AdvaMed conference in San Francisco. Reed Miller discusses the latest cost-effectiveness study of Boston Scientific’s Watchman left-atrial appendage closure device.
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Medtech Insight articles addressing topics discussed in this episode.
Expert Panel Discusses Impact Of Stricter US, EU Data Privacy Laws On Medtech Industry http://bit.ly/2XydvJI
CES 2016: Consumer and Medical Devices Come Together in Digital Health http://bit.ly/30fZeCG
Long-Term Analysis Shows Boston Scientific’s Watchman Device Saves Money http://bit.ly/2Xr4KAD
Global Device Approvals, Weekly Snapshot: FDA Approves Bard’s Venovo Stent; Abbott’s MitraClip Gets Indication-Expansion; Boston Scientific’s Watchman FLX Earns CE Mark http://bit.ly/2LaaVYb
Starts & Stops: Boston Scientific Completes Enrollment In Precision SCS, Watchman FLX, Lotus TAVR, Ranger II SFA Studies http://bit.ly/2xxRRdo
It may often seem like Brexit is the only story in town in the UK, but within health care and medtech, a lot of system transformation and future planning for access to medtech innovation is underway, as this Medtech Insight podcast with Ashley Yeo and Amanda Maxwell underlines.
In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about her upcoming Market Intelligence story based on interviews with the biggest players in the diabetes market at the recent annual American Diabetes Association meeting. Reed Miller discusses Global Kinetics' recent data on its Personal KinetiGraph that can help identify Parkinson's patients most likely to benefit from device-assisted therapy and Myriad Genetics' POLO trial results.
Listen to the podcast via the player below:
https://medtech.pharmaintelligence.informa.com/MT125248/ADA-Exec-Chat-Hiten-Chawla-Medtronics-VP-Of-Global-Marketing-Discusses-Diabetes-Business-Plans
https://medtech.pharmaintelligence.informa.com/MT125209/Glooko-Inks-Partnership-Deal-With-Companion-Medical-To-Integrate-Insulin-Pen-Data
https://medtech.pharmaintelligence.informa.com/MT125203/Glooko-And-T1D-Exchange-Enter-Partnership-To-Leverage-Device-Data-From-Type-1-Diabetics
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
Global Kinetics’ Personal KinetiGraph Identifies Parkinson’s Patients Suitable For Deep Brain Stimulation https://medtech.pharmaintelligence.informa.com/MT125266/Global-Kinetics-Personal-KinetiGraph-Identifies-Parkinsons-Patients-Suitable-For-Deep-Brain-Stimulat
Myriad Foresees Important Role For Genetic Testing In Pancreatic Cancer, Breast Cancer, And Beyond https://medtech.pharmaintelligence.informa.com/MT125251/Myriad-Foresees-Important-Role-For-Genetic-Testing-In-Pancreatic-Cancer-Breast-Cancer-And-Beyond
https://medtech.pharmaintelligence.informa.com/MT125258/Why-Unprecedented-Numbers-Are-Flocking-To-Brussels-In-Uncertain-Times
https://medtech.pharmaintelligence.informa.com/MT125264/Lack-Of-Funding-Stalls-Major-US-FDA-Cybersecurity-Initiative
In this week's Medtech Insight podcast, executive editor Shawn M. Schmitt and senior reporter Sue Darcey discuss recent reporting on efforts by US senators to control and stop Chinese researchers in the US from using their research jobs at the National Institutes of Health, and at American medical colleges and universities, to steal genomic data and share it with the Chinese government. Medtech Insight articles addressing topics discussed in this episode: • US Senators Ask HHS IG To Investigate CMS Genetic Test Payments To Chinese Firms (https://medtech.pharmaintelligence.informa.com/MT125235/US-Senators-Ask-HHS-IG-To-Investigate-CMS-Genetic-Test-Payments-To-Chinese-Firms) • Sen. Cornyn Plans Bill To Secure US Genomic Research From Foreign 'Interference, Espionage And Exfiltration' (https://medtech.pharmaintelligence.informa.com/MT125225/Sen-Cornyn-Plans-Bill-To-Secure-US-Genomic-Research-From-Foreign-Interference-Espionage-And-Exfiltra)
In this edition of Device Week, Medtech Insight's Marion Webb discusses the AdvaMed MedTech Conference in San Francisco which focused on digital health devices and senior reporter Catherine Longworth discusses the Inhalation & Respiratory Drug Delivery device meeting held in New York City.
In this edition of Device Week, Medtech Insight's Catherine Longworth reports on her experience at the BIOMEDevice meeting in Boston, where she talked to CEO Scot Huennekens, the former CEO of Verb Surgical, the robotics start up formed by Google and Johnson & Johnson’s Ethicon. Verb is combining robotics, advanced instrumentation, advanced visualization, data analytics and machine learning to create a platform for digital surgery, rather than trying to compete with the existing surgery robotics companies like Intuitive Surgical.
Medtech Insight articles addressing topics discussed in this episode.
SAGES 2019: Spotlighting Competitive Robotic Systems And Procedures
Johnson & Johnson Diversifies Robotic Efforts With Auris Health Acquisition
New Report Spotlights Intensifying Rivalry Between Tech And Health-Care Companies :: Medtech Insight
In this week's Medtech Insight podcast, Danny Al-Faruque discusses a recent speech by former FDA head Scott Gottlieb at the National Press Club in Washington, DC, that focused on product reimbursement issues. And Sue Darcey talks about a new push by US Rep. Rosa DeLauro to remove PMA-product liability suit protections for devices, with her reintroduction of the Medical Device Safety Act. Medtech Insight articles addressing topics discussed in this episode: • From Regulation To Reimbursement: Ex-FDA Chief Says CMS Needs New Reimbursement Frameworks https://medtech.pharmaintelligence.informa.com/MT125112/From-Regulation-To-Reimbursement-ExFDA-Chief-Says-CMS-Needs-New-Reimbursement-Frameworks • US Rep. DeLauro Reintroduces Device Safety Bill To Remove PMA Product Liability Suit Protections https://medtech.pharmaintelligence.informa.com/MT125103/US-Rep-DeLauro-Reintroduces-Device-Safety-Bill-To-Remove-PMA-Product-Liability-Suit-Protections
In this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her upcoming Market Intelligence story covering the global arthroscopy and sports medicine products market, based on Informa's new Meddevicetracker report, with a focus on the fast-growing hip arthroscopy market. Reed Miller discusses Biotronik's new BIO-LIBRA study designed to measure sex-specific outcomes in patients with non-ischemic cardiomyopathy treated with implantable cardioverter defibrillators (ICD) and cardiac resynchronization defibrillators (CRT-D).
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Medtech Insight articles addressing topics discussed in this episode:
Biotronik Starts First ICD Study Designed To Measure Sex-Specific Outcomes https://medtech.pharmaintelligence.informa.com/MT125074/Biotronik-Starts-First-ICD-Study-Designed-To-Measure-SexSpecific-Outcomes
In this week's Medtech Insight podcast, Sue Darcey and Shawn M. Schmitt discuss what a rash of new “Medicare for All” bills being explored by the US Congress and several 2020 Democratic presidential hopefuls could mean for the medtech and diagnostics industry.
Medtech Insight articles addressing topics discussed in this episode: • Medtech CEOs Like Stryker's Lobo 'Scared' Of 'Medicare For All' Driving Lower Device Prices, Former CMS Chief Says
In this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her Start-Up Spotlight feature on Paragonix Technologies, which hopes to replace conventional organ transportation with its newly launched SherpaPak system. Reed Miller discusses the impact of Boston Scientific's entry into the US TAVR market after the US FDA approved its Lotus Edge TAVR system.
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Medtech Insight articles addressing topics discussed in this episode:
Boston Scientific Becomes Third US TAVR Competitor With Lotus Edge Approval Transcatheter Systems Set To Dominate Heart Valve Market Start-Up Spotlight: Paragonix Wants To Put 'More Heart' Into Transporting Organs
Frans van Houten, CEO of Philips, talked about the future of AI and what his company is doing to be a part of it. He spoke with Medtech Insight at the World Medical Innovation Forum.
In this week's Medtech Insight podcast, Shawn M. Schmitt explains why the FDA ordered transvaginal mesh products removed from the US market, and Ferdous Al-Faruque highlights a growing device-shortage issue linked to problems at two US sterilization facilities. Medtech Insight articles addressing topics discussed in this episode:
• FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan • There's A Pediatric Air-Tube Shortage Because A Sterilization Facility Was Shut Down • Sterilization Facility Shutdowns Could Spell Medical Device Shortage; FDA Urges Firms To Assess 'Downstream Impacts'
The associate director for digital health talked with Medtech Insight at the World Medical Innovation Forum about international interest in the agency’s precertification pilot program and what is needed to get a new draft guidance on artificial intelligence. Tags: bakul patel, medical devices, artificial intelligence, pre-cert, digital health, AI, guidance, FDA, world medical innovation forum, WMIF19
In this edition of Device Week, Catherine Longworth reports on eye-care giant Alcon's $28bn spin-off from Novartis. Marion Webb reviews her interview with executives from EOS imaging SA, a developer of imaging medical devices for orthopedics.
Medtech Insight articles addressing topics discussed in this episode:
All 'Bye' Itself: Alcon Spins Out From Novartis In $25Bn Stock Listing https://bit.ly/2G4qLhX
Adios To Alcon In April As Novartis Confirms Spin-Off Date https://bit.ly/2Z1xbXA
The Many Layers Of EOS Imaging – Surgical Planning, Low-Dose Imaging, 3D Services https://bit.ly/2Gf8lwd
In this week’s podcast, Medtech Insight journalists Shawn M. Schmitt, Ferdous Al-Faruque and Elizabeth Orr discuss a recent flurry of guidance document news from US FDA on facility inspections, artificial intelligence and anthrax detection devices. Medtech Insight articles addressing topics discussed in this episode: • With Fresh Guidance, US FDA Aims For Consistency In Device Facility Inspections (https://protect-us.mimecast.com/s/fbN6CQWNOwhkRVZoLsPtuEU?domain=medtech.pharmaintelligence.informa.com) • Rise Of The Machines: FDA Artificial Intelligence Guidance Is Coming (https://protect-us.mimecast.com/s/BJD-CR6MLxfvOYZ5XTPiIw3?domain=medtech.pharmaintelligence.informa.com) • After Years Of Waiting, FDA Classifies Anthrax Detection Devices As Class II (https://protect-us.mimecast.com/s/cBW0CVO5NBcxZBQg8sJEbEK?domain=medtech.pharmaintelligence.informa.com)
In this week's podcast, Medtech Insight's Catherine Longworth discusses UK Oxfordshire's plans to create a regional 'digital-health' hub. And Marion Webb talks about meeting with leaders from Zimmer Biomet and DePuy Synthes to discuss robotic systems and other solutions presented at the recent American Academy of Orthopedics Surgeons' conference in Las Vegas.
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Medtech Insight articles addressing topics discussed in this episode:
Zimmer Biomet's ROSA One Spine System Wins FDA Nod; Other Solutions Presented At AAOS 2019 AAOS Exec Chat: An Insider Look Into DePuy Synthes' Anterior Approach AAOS Results Recap: Stryker’s Knee-Surgery Robot And Miach’s New ACL Scaffold AAOS 2019: OSSO VR Develops VR Training Tool For Smith & Nephew's NAVIO Robot, And More On Orthorobotics UK Champions Oxfordshire As Next Global Digital Health Hub What Brexit Effect? UK Biotech Start-Ups Reach Record Numbers
In Vivo discusses ways to enhance the visibility of the market access function in biopharma with two leaders of a 20-company initiative to promote best practices in the field: Indranil Bagchi, Senior Vice-President, Global Value and Access, Novartis Oncology; and Srikant Vaidyanathan, Senior Partner and Managing Director, the Boston Consulting Group.
FDA Commissioner Scott Gottlieb spoke at the Brookings Institution March 20 to talk about his departure from the agency. He noted that among the top issues that he hopes will be addressed after he leaves on April 5, are legislation addressing over-the-counter drugs and laboratory developed tests under a in-vitro clinical test bill known as the VALID Act.
In this week’s podcast, senior reporters Elizabeth Orr and Ferdous Al-Faruque give a quick rundown of FDA goings-on the device industry should keep a sharp eye on, including a reorganization of the Center for Devices and Radiological Health, remarks from outgoing agency head Scott Gottlieb on laboratory developed tests, and news from a recent FDA neurological devices advisory panel meeting. Medtech Insight articles addressing topics discussed in this episode: • FDA Device Center Reorg Set To Roll Out This Week https://medtech.pharmaintelligence.informa.com/MT124798/FDA-Device-Center-Reorg-Set-To-Roll-Out-This-Week • Neuro Devices Panel Skeptical On Alzheimer’s Treatment https://medtech.pharmaintelligence.informa.com/MT124823/Neuro-Devices-Panel-Skeptical-On-Alzheimers-Treatment
One of the top US medical device lobbyists spoke to Medtech Insight about their work to extend a moratorium on the medical device excise tax and getting reimbursement for medical devices sooner. He commended FDA Commissioner Scott Gottlieb and their work to implement provisions in MDUFA IV.
In this edition of Device Week, Medtech Insight’s Catherine Longworth discusses Smith & Nephew’s $660m acquisition of regenerative medicine company Osiris Therapeutics and Reed Miller talks about the clinical trial highlights from the recent CRT Meeting in Washington and looks forward to the American College of Cardiology conference next week.
For more information on Medtech Insight and to start a free trial, click here. https://pharmaintelligence.informa.com/products-and-services/news-and-insights/medtech-insight
Medtech Insight articles addressing topics discussed in this episode: AAOS 2019: OSSO VR Develops VR Training Tool For Smith & Nephew's NAVIO Robot, And More On Orthorobotics https://bit.ly/2XOGuto
2018 Earnings Spotlight: Stryker And Nuvasive Lead The Ortho Pack In 2018 https://bit.ly/2TAB3je
Exec Chat: New Smith & Nephew CEO Namal Nawana Outlines Growth Strategy At JP Morgan https://bit.ly/2GHcWIi
Results Recap: CRT In DC Features New Biotronik Stent Data, Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal Denervation https://bit.ly/2W1CkfV
Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive https://bit.ly/2TLcfEF
2018 Earnings Spotlight: Transcatheter Valve Repair Remains Big Drivers For Medtronic, Edwards, Abbott https://bit.ly/2VIoQ8V
On the latest Medtech Insight podcast, David Filmore and Ferdous Al-Faruque discuss the unexpected news that Scott Gottlieb is leaving US FDA next month. What has been his legacy for medtech, and who will replace him? For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: •Scott Gottlieb Calls It Quits After An Active Tenure At US FDA: https://bit.ly/2SRlQVM •Gottlieb Wants His US FDA Team To Stay Together After He Departs: https://bit.ly/2HkWQUO
In the last decade, anti-PD-1/L1 checkpoint inhibitors have been revolutionary in oncology, but while the impact has been dramatic, many patients still do not respond. Dan Chen, M.D., Ph.D., former global head of the cancer immunotherapy franchise at oncology leader Roche/Genentech, talks to Scrip and Pink Sheet journalist Emily Hayes about the cancer immunity cycle, lessons learned from trials of combinations of drugs and more. Recorded onsite at the ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco on March 1, 2019.
In this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her upcoming Market Intelligence story on the global breast cancer imaging and biopsy market with Reed Miller highlighting late-breaking trials that will be presented at the upcoming American College of Cardiology Conference in New Orleans.
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Medtech Insight articles addressing topics discussed in this episode:
Breast Surgeons Advise All Breast Cancer Patients Be Offered Genetic Testing https://medtech.pharmaintelligence.informa.com/MT124656/Breast-Surgeons-Advise-All-Breast-Cancer-Patients-Be-Offered-Genetic-Testing
2018 Earnings Spotlight: Transcatheter Valve Repair Remains Big Drivers For Medtronic, Edwards, Abbott https://medtech.pharmaintelligence.informa.com/MT124703/2018-Earnings-Spotlight-Transcatheter-Valve-Repair-Remains-Big-Drivers-For-Medtronic-Edwards-Abbott
TCT 2018: Abbott Expects COAPT Results To Support Expanding MitraClip's Indication https://medtech.pharmaintelligence.informa.com/MT123311/TCT-2018-Abbott-Expects-COAPT-Results-To-Support-Expanding-MitraClips-Indication
In this week’s podcast, senior reporter Sue Darcey talks about troubling developments for US laboratories and diagnostic test-makers that say the Government Accountability Office was mistaken in conclusions it reached in a recent report about how much labs will be billing Medicare for clinical tests. Also discussed are comments lab associations sent to US legislators, who have been trying to win industry and stakeholder consensus on a regulatory reform proposal for laboratory developed tests (LDTs) that they call the VALID Act. Medtech Insight articles addressing topics discussed in this episode: • Lab Groups Disagree With GAO That Medicare Will Be Overbilled For PAMA Test Payments https://medtech.pharmaintelligence.informa.com/MT124672/Lab-Groups-Disagree-With-GAO-That-Medicare-Will-Be-Overbilled-For-PAMA-Test-Payments
Brian Chapman of consulting firm ZS talks to In Vivo in this podcast about the big challenges and the climate of change for medtechs in 2019
Several 2018 cases and a new USPTO guideline have added to the patent-eligibility discourse. Harness Dickey’s Chris Cauble talked to Medtech Insight about what patent-seekers need to know and do to win their patents.
In this edition of Device Week, Medtech Insight’s Reed Miller talks to managing editor Marion Webb about the growing interest among investors in "femtech," technology that specifically addresses women's health issues that have been frequently overlooked in the past. And London-based reporter Catherine Longworth addresses the recent media reports that Smith & Nephew may make a bid for spine-device company Nuvasive.
For more information on Medtech Insight and to start a free trial, click here.
Medtech Insight articles addressing topics discussed in this episode:
Market Intel: Let's Talk About It — The Rising Tide Of 'Femtech' Companies
Exec Chat: New Smith & Nephew CEO Namal Nawana Outlines Growth Strategy At JP Morgan
The burgeoning Medical Device Single Audit Program is the focus of this week’s podcast. Deputy editor Shawn M. Schmitt talks about the latest news on MDSAP and shares some tips for acing an MDSAP audit. Medtech Insight articles addressing topics discussed in this episode: • Canada's Switch From CMDCAS To MDSAP Went Off Without A Hitch – Despite 403 Firms Leaving The Market • MDSAP Is A Snap If Your Firm Follows Quality Systems Standard ISO 13485, Auditor Says • Compliance Corner: MDSAP Auditor Answers 5 Frequently Asked Questions • Compliance Corner: 8 Handy Tips From An MDSAP Auditor To Help You Ace Your Next Audit
In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about Livongo's acquisition of behavioral health company myStrength and with Reed Miller about the controversy surrounding the meta-analysis finding of a higher mortality risk with paclitaxel-eluting peripheral devices.
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Medtech Insight articles addressing topics discussed in this episode:
SCAI, Manufacturers Defend Peripheral Paclitaxel Devices Against Doubts
Livongo Buys Behavioral Health Firm in Multimillion Dollar Deal, Plans to Hire 300-500 People
On this week’s podcast, deputy editor Shawn M. Schmitt gives a roundup of recent Compliance Corner and Medtech Tips reports that featured combination drug-device product advice from quality experts at Eli Lilly and Johnson & Johnson. Medtech Insight articles addressing topics discussed in this episode: • Medtech Tips: Should A Combo Product-Maker's Quality System Be Device- Or Drug-Led? J&J, Eli Lilly Experts Weigh In https://medtech.pharmaintelligence.informa.com/MT124525/Medtech-Tips-Should-A-Combo-ProductMakers-Quality-System-Be-Device-Or-DrugLed-JJ-Eli-Lilly-Experts-W • Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak https://medtech.pharmaintelligence.informa.com/MT124506/Compliance-Corner-JJ-Quality-Expert-Urges-Makers-Of-Combo-Products-To-Be-Bilingual-In-Device-And-Dru • Compliance Corner: In Today's 24/7 World, Have Experts On Call For FDA Inspections, Eli Lilly Quality Director Says https://medtech.pharmaintelligence.informa.com/MT124513/Compliance-Corner-In-Todays-247-World-Have-Experts-On-Call-For-FDA-Inspections-Eli-Lilly-Quality-Dir • Compliance Corner: Having A Tight Grip On Suppliers Is Critical For Combination Product Manufacturers https://medtech.pharmaintelligence.informa.com/MT124534/Compliance-Corner-Having-A-Tight-Grip-On-Suppliers-Is-Critical-For-Combination-Product-Manufacturers
In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about some key takeaways at this year's JP Morgan Healthcare conference. That includes a Q&A with Smith & Nephew's new CEO, Namal Nawana on his growth strategy for the British medtech giant, new partnership announcements between medtech and tech companies, and trends in digital health.
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Medtech Insight articles addressing topics discussed in this episode:
Bringing A Digital Pill to Oncology: Proteus Partners With Health System To Prescribe Sensor-Enabled Chemotherapy
Exec Chat: New Smith & Nephew CEO Namal Nawana Outlines Growth Strategy At JP Morgan
Ascensia Inks Distribution Deal To Enter CGM Market
On this week's podcast, Ashley Yeo talks about a the "Long Term Plan" for the UK's health-care system published by the country's NHS this week, and the implications of Brexit. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.
Medtech Insight articles addressing topics discussed in this episode: NHS' New Plan: 'Long-Termism' Is Also Needed In Adoption And Spread Of Technology In UK: https://bit.ly/2D61q6T ABHI 30: NHS Long-Term Plan Promises Diagnosis And Tech Uptake Boost For Industry And Patients: https://bit.ly/2FsOoSo Brexit At The 11th Hour: UK Refreshes No-Deal Guidance For Medtech : https://bit.ly/2RJyfib
In this edition of Device Week, Medtech Insight’s Catherine Longworth reviews the year in mergers and acquisitions – including big moves by Medtronic, Stryker, and Boston Scientific. Looking forward to 2019, companies will be looking for acquisitions to help them take advantage of the emergence of Asia as the second-biggest device market, respond to Brexit, and potentially cope with new device regulations around the world.
For more information on Medtech Insight and to start a free trial, click here: https://bit.ly/2LPIfkC
Medtech Insight articles addressing topics discussed in this episode:
Boston Scientific's Drive To Add To Core Strength Continues With BTG Buy https://invivo.pharmaintelligence.informa.com/IV124150/Boston-Scientifics-Drive-To-Add-To-Core-Strength-Continues-With-BTG-Buy
Major M&A Bookends Year Of Mainly Steady Growth For Leading Medtech Groups https://scrip.pharmaintelligence.informa.com/SC124342/Major-MA-Bookends-Year-Of-Mainly-Steady-Growth-For-Leading-Medtech-Groups
Stryker Makes Big Investment In Spine Surgery With $1.4Bn K2M Acquisition https://medtech.pharmaintelligence.informa.com/MT123208/Stryker-Makes-Big-Investment-In-Spine-Surgery-With-14Bn-K2M-Acquistion
Israel's Medtech Market Evolution: Seeking The Next Big Thing https://invivo.pharmaintelligence.informa.com/IV124142/Israels-Medtech-Market-Evolution-Seeking-The-Next-Big-Thing
Deals and Financings https://medtech.pharmaintelligence.informa.com/commercial/deals-and-financings
On this week’s podcast, senior reporter Elizabeth Orr gives a recap on the year in US legal news and how the courts impacted the medical device industry, from new Supreme Court justices Neil Gorsuch and Brett Kavanaugh to multimillion-dollar settlements in device safety cases – and much more.
Senior Medtech Insight Reporter Ferdous Al-Faruque talked about some of the discussions that took place at the summit and what they mean for industry. He opines what we can expect to see in 2019 and what industry should keep an eye on.
Researchers Apply Cancer Radiation To Cardiac Arrhythmia In this edition of Device Week, Medtech Insight’s weekly podcast, managing editor Marion Webb gives an overview of physicians’ perspective of digital apps for diabetes patients and Deputy Editor Reed Miller discusses the early research into a potentially promising non-invasive radiation technique for treating ventricular tachycardia.
For more information on Medtech Insight and to start a free trial, click here.
Medtech Insight articles addressing topics discussed in this episode:
Market Intel: Managing Diabetes With Digital Apps: Physicians' Views On Pros And Cons
[The other one is coming soon]
On this week's podcast, David Filmore talks to Elizabeth Orr and Reed Miller on the outcomes of this week's FDA Circulatory System Devices Panel, where agency advisors addressed a "Breakthrough" heart failure device and the data needs for hypertension devices. Listen to the podcast via the player below:
Articles addressing topics discussed in this podcast:
FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device https://bit.ly/2E7YwzC
Work With Patients To Design Trials For Anti-Hypertensive Devices, FDA Advisors Suggest https://bit.ly/2G42YSl
The CARE Awards 2019 is your opportunity to be recognized in the company of other luminaries in the industry for your outstanding contributions toward improving the quality of life for present and future generations around the globe. Don’t wait – submit your 2019 CARE Awards nomination today!
In this edition of Device Week, Medtech Insight managing editor Marion Webb discusses the ongoing research that could lead to 3D-printing of human replacement organs and Catherine Longworth highlights the developments in “femtech,” medical technology primarily or exclusively for female patients.
Articles addressing topics discussed in this episode:
Market Intel: Cornea, Bio-Drugs, Artificial Hips On Track For 3D Printing https://bit.ly/2DB85a1
International Women's Day: Medtech's Women Movers & Shakers https://bit.ly/2FiGPPz
Scrip Asks… What Are The Biggest Barriers To Women In Leadership Roles? https://bit.ly/2KHyBzY
This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourteenth installment, former FDA investigations branch director Ricki Chase explains how device-makers can leverage publicly available data from the agency to determine where they might fall short when it comes to complying with FDA rules and regulations.
The device industry is bracing for of an in-depth, global investigation of the sector that is anticipated from an international consortium of journalists. AdvaMed’s top officials talk about their concerns with the project and plans to respond.
On this week's podcast, Elizabeth Orr and David Filmore discuss FDA's recent Patient Engagement Advisory Committee and a recent announcement from the agency about post-market surveillance updates and investments. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles referenced in this podcast: FDA Wrestles With Social Media At Patient Engagement Meeting: https://bit.ly/2FLJIJt https://medtech.pharmaintelligence.informa.com/articles/2018/11/16/fda-wrestles-with-social-media-at-patient-engagement-meeting
FDA Looks To Lead World In Post-Market Device Surveillance With Safety Plan, Investments: https://bit.ly/2S7rbZo
On this week’s podcast, Reed Miller talks to Medtech Insight’s managing editor Marion Webb about digital health technologies of the future, showcased at the Exponential Medicine conference in San Diego, featured in depth in the latest Market Intelligence story. Medtech Insight’s deputy editor Reed Miller introduces Medtech Insight’s new “Tracking Trials” section, which features a list of trials that are starting, ending or finishing enrollment; including the “Results Recap,” a summary of trials that announced results. He also gives an update of key clinical trial news from this week’s American Heart Association meeting in Chicago. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.
Medtech Insight articles referenced in this podcast:
Market Intel: Apps For Epilepsy, Steps for Health, Meditation Guides, Mouth Labs Cross Digital Divide For Better Health https://bit.ly/2yZR9b7 Abiomed Touts New Study Results, Potential To Revolutionize Heart-Attack Treatment https://bit.ly/2Tifi4a
Results Recap: VIVA Conference Yields Plethora Of Vascular Intervention Data https://bit.ly/2Pw065j
Q3 Earnings Spotlight: Abiomed Shines Among Cardiology Device-Makers https://bit.ly/2Fmdynj
On this week's podcast, David Filmore and Ferdous Al-Faruque discuss the results of this week's midterm elections in the US and what it could mean for the medtech sector. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.
Medtech Insight articles referenced in this podcast: 3 Big Medtech Takeaways From US Midterms https://bit.ly/2PhO6UL US Midterms: Industry Loses Some Supporters In Congress, But Retains Many https://bit.ly/2SU86eb
Have you submitted your nomination to the 24th Annual OTC Marketing Awards yet? This spectacular evening honouring the achievements of those making important contributions to the British OTC industry is coming soon, and you can be a part of the excitement.
Learn more about how you can nominate your campaigns, brand or organisation for one or more of these unique awards that focus exclusively and entirely on suppliers of OTC products – non-prescription medicines, food supplements, and selected unlicensed healthcare products in the pharmacy, retail and grocery sectors.
On this week's podcast, Reed Miller and Catherine Longworth give an overview of the third-quarter earnings reports from the major public companies in the IVD, cardiovascular, and orthopedics device sectors.
Medtech Insight articles addressing topics discussed in the is episode:
Focus More On Patients, Less On Hospitals, Experts Tell Device Companies
Stryker Strikes Again, Buys HyperBranch Medical Technology
TAVR Update: Edwards Delays European Launch Of Sapien 3 Ultra; New Medtronic CoreValve Data
Boston Scientific Hooks In Millipede, But Still Trailing Behind In Mitral Valve Race
Market Intel: NANS 2018: Positive Data Intensifies Spinal-Cord Stim's Big-Four Rivalry
On this week's podcasts, David Filmore talks to Sue Darcey about the opioids bill enacted in the US this week, including an expansion of "sunshine" payment reporting requirements for device-makers. And Elizabeth Orr discusses some recently launched 510(k)-process pilot programs and questions industry has about them. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.
Medtech Insight articles on topics addressed in this episode:
President Signs Opioids Bill Calling For Alternative Tech, More Pain-Control Research” https://bit.ly/2OPJpkX Proposed 510(k) Changes Elicit Some Industry Skepticism: https://bit.ly/2CJIWtk Expanded Sunshine Provisions Will Burden Industry, Yield Little, Attorneys Say: https://bit.ly/2ELuGmj
In this edition of Device Week, Medtech Insight’s Marion Webb gives an overview of her new Market Intelligence article on innovative digital technologies applied to cardiology and Catherine Longworth reports on a Hermarina – a company in Brittany helping to build France’s ‘blue economy’ based on marine resources – which has developed several products, including a blood-replacement therapy, from a certain type of sandworm.
For more information on Medtech Insight and to start a free-trial, click here. https://bit.ly/2BbtrcT
Medtech Insight articles on topics addressed in this episode: Minister's 'Upfront' Approach On Brexit Can Be Blueprint For Wider UK Industry Engagement https://bit.ly/2BbtrcT
Apple And Zimmer Biomet To Study Patient Experience With Joint Replacement Surgery https://medtech.pharmaintelligence.informa.com/MT123436/Apple-And-Zimmer-Biomet-To-Study-Patient-Experience-With-Joint-Replacement-Surgery
US FDA Commish Defends Approach To Apple Approvals https://medtech.pharmaintelligence.informa.com/MT123353/US-FDA-Commish-Defends-Approach-To-Apple-Approvals
Medtech Insight senior reporters Ferdous Al-Faruque and Sue Darcey talk about how the upcoming US midterm elections could shake things up for the medical device industry in this week’s podcast.
Medtech Insight articles addressing topics discussed in this episode: • Lots of Oversight But Little Legislation Expected If Dems Take House https://bit.ly/2QL6bqs • Device Industry Champion Erik Paulsen In Tough Election Fight To Retain House Seat https://bit.ly/2yvmCj2
In this edition of Device Week, Medtech Insight’s Reed Miller and Catherine Longworth discuss the efforts of national, regional, and local governments to bring in medtech investment, discussing examples from Lithuania, Ireland, and Texas.
Brexit Trade Deal Must Wait, But UK Medtech Sector Finds Reasons To Be Cheerful https://bit.ly/2xZ6Uxt
UK Device Manufacturers Must Contingency Plan For A Hard Brexit https://bit.ly/2yl82IO
Innovation Driving Ireland's Transition From Medtech Supplier To Strategic Partner https://bit.ly/2xyBU4U
Coinciding with Cybersecurity Awareness Month in October, FDA’s Suzanne Schwartz talked to Medtech Insight about a slew of related initiatives to bolster connected security on medical devices but argues however the agency needs more resources to be effective.
On this week's podcast, we discussed some key takeaways from this week's MedTech Conference, including a significant focus on the need for device companies to become data companies and establish new ways to directly engage patients to compete in the new digital reality. Also, some FDA digital health updates, and discussion of the China tariffs. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles addressing topics discussed in this episode:
The Medtech Conference: Industry Is Falling Short In Digital Investments https://bit.ly/2OpfP4M Jeff Shuren Talks Breakthrough Bonanza, TPLC And Innovating Safety https://bit.ly/2Qa2iLx AdvaMed Chair Nadim Yared Talks Challenges, Priorities https://bit.ly/2IpWZoy
Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must jump to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.
Medtech Insight articles addressing topics discussed in this episode: • Assessing A Device-Maker's Manufacturing Capability Is Serious Business For These 2 Longtime CMMI Appraisers. Here’s Their Story https://bit.ly/2pnSFNR • FDA Staffers, Device Firm Employees Are Training As Appraisal Team Members For CMMI Maturity Model Pilot https://bit.ly/2MR6D40 • Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience https://bit.ly/2K69U34 • Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised https://bit.ly/2K6TWRV • Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites https://bit.ly/2jGPlL1
After announcing his departure from AdvaMed, JC Scott, the long running chief advocacy officer, and his successor Greg Crist, the current top public affairs officer, talked to Medtech Insight about their legislative agenda and future priorities.
In this edition of Device Week, Medtech Insight’s Reed Miller talks to editor David Filmore about the latest good news for LivaNova and London-based reporter Catherine Longworth provides and update on Creavo Medical, a UK-based company using an old technology for a new kind of cardiac diagnostic that could save hospitals a lot of money in the treatment of patients suspected of having a heart attack.
For more information on Medtech Insight and to start a free trial https://medtech.pharmaintelligence.informa.com/subscribe
Start-Up Spotlight: Creavo Medical, Diagnosing Myocardial Ischaemia With MCG
NICE Endorses Sutureless Aortic Valves While LivaNova Reaches Study Milestone
TRD Societal Cost Can Sway US Payer On VNS Coverage Decision
CDRH Director Jeff Shuren spoke to Medtech Insight at the MDIC Annual Forum about a risk-benefit uncertainty guidance US FDA released that day. He says he hopes the guidance will provide clarity to industry about the circumstances when FDA will accept different levels of uncertainty.
On this week’s podcast, Medtech Insight’s Ferdous Al-Faruque and Shawn M. Schmitt discuss “The Bleeding Edge,” a new Netflix documentary by Oscar-nominated director Kirby Dick that is highly critical of the medical device industry and US FDA.
Medtech Insight article addressing topics discussed in this episode: • Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary https://bit.ly/2wmlb6t
Susan Van Meter, executive director of AdvaMedDx, sat down with Medtech Insight to talk about what she’s learned in the nine months on the job and what issues she’s focusing on to represent the interests of the diagnostics industry.
The medtech industry’s number one player, Medtronic, is the focus of this edition of Device Week, as the firm hit the headlines with some impressive first fiscal quarter results and positive data from a trial of its Synchromed II drug infusion pump. Medtech Insight’s Reed Miller and Tina Tan chat about what helped to boost the company’s top- and bottom-lines and delve deeper into the SISTERS trial for Synchromed and the impact these results will have on the company’s pain management business. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
Medtronic's Eyes Are Still Peeled For M&A, But Organic Growth Is The Primary Goal Positive SISTERS Data Could Lift Medtronic's SyncroMed II From Recall Repercussions https://medtech.pharmaintelligence.informa.com/articles/2018/08/21/medtronics-eyes-are-still-peeled-for-ma-but-organic-growth-is-the-primary-goal
On this week’s podcast, Medtech Insight’s Shawn M. Schmitt talks about his recent reporting on US FDA’s plans to merge its bedrock rule for manufacturing safe and effective devices in the United States with international quality systems standard ISO 13485.
Medtech Insight article addressing topics discussed in this episode: • QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like https://bit.ly/2wbVDbg • The QSR/ISO 13485 Maze: How FDA's Satellite Device Rules Will Complicate A Quality System Regulation Rewrite https://bit.ly/2w9ONTx • US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485 https://bit.ly/2IwdTnK
Medtech Insight caught up with FDA’s Vasum Peiris immediately after a two-day workshop on pediatric medical devices to discuss what the agency learned and how the field may change based on the discussions.
In this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her latest Market Intelligence story focusing on the liquid biopsy market and emerging companies.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
Market Intel: Liquid Biopsy I - Analyzing Market Landmarks and Landmines https://bit.ly/2w6lEZz
On this week’s podcast, Medtech Insight’s Catherine Longworth and Ferdous Al-Faruque talk about surgical guidance company Endomag, which recently secured a landmark approval from US FDA for its combination breast cancer product Sentimag and Magtrace.
Medtech Insight article addressing topics discussed in this episode: New Cancer Center Played Pivotal Role In Endomag's Success https://bit.ly/2MzCl6u
US FDA's new Oncology Center for Excellence brought in key experts to help review and approve Endomag's new Magtrace and Sentimag System combination product to help surgeons trace and remove breast tumors. The case highlights how disease-specific centers could change the way the agency reviews products.
Device Week, Aug. 1, 2018 – A Closer Look At Cancer Surgical Ablation
In this edition of Device Week, Medtech Insight’s Tina Tan chats to finds out more about the fast-growing market for surgical ablation devices to treat cancer. Marion Webb gives an insight into the speed at which the market is expanding and who are the emerging innovators. Catherine Longworth then discusses in more detail one of the more established players in this field, Medtronic, which has installed its Visualase system in the UK for the first time after getting a CE mark recently.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: Market Intel: New Thermal Therapies Blaze Trail In Fast-Growing Cancer Ablation Market - https://bit.ly/2vpr6GA Medtronic's Visualase Tumor Ablation Tech Beams Into UK Market - https://bit.ly/2LRkaMx
On this week's podcast, Reed Miller talked about the Medicare Evidence Development & Coverage Advisory Committee's recent gathering to discuss transcatheter aortic valve replacement coverage policies and the debate over hospital and physician volume requirements. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode: Medicare Advisors Mostly Favor TAVR Center Volume Thresholds: https://bit.ly/2K1pmII CMS Is Taking Another Look At Its TAVR Coverage Rules: https://bit.ly/2vevpEK CMS Policy Sets Boundaries On Transcatheter Valve Procedure: https://bit.ly/2AhBC8u
The issue of antimicrobial resistance (AMR) has been stalking global public health for a number of years - and governments, heath authorities and the international scientific community as a whole is finally starting to take action. In this podcast Mike Ward of Informa talks to Dr Peter Jackson, executive director of the AMR Centre, a public-private partnership, which is based at Alderley Park, Cheshire, and leads the UK response to the crisis.
In this edition of Device Week, Medtech Insight’s Tina Tan discusses trends in VC financing and M&A activity for medtech in 2018. Davide Filmore explains FDA’s latest approvals numbers, and Reed Miller gives an overview of the state of medical device approvals from outside the US.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: VC Deals Analysis: Mega-Rounds Abound, As H1 Deal Value Rockets Past $4Bn https://bit.ly/2LtnAVw ReCor Deal Underscores RDN Revival – But Also Reason For Backing Medtech? https://bit.ly/2L5ymSM US Device Approvals Q2 Snapshot: Cook Clearances Continue; Novel Device Approvals Pick Up https://bit.ly/2NvKKbr Global Device Approvals Q2 Shapshot: Coronary Devices Abound https://bit.ly/2LuPMUS
Part 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method.
Medtech Insight articles addressing topics discussed in this episode: Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience https://bit.ly/2K69U34 Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised https://bit.ly/2K6TWRV Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites https://bit.ly/2jGPlL1
In this edition of Device Week, Medtech Insight editor Marion Webb reports on the American Diabetes Association conference in Orlando and editor Reed Miller runs down the latest corporate restructuring news.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR m
Medtech Insight articles addressing topics discussed in this episode:
ADA2018: Insulet Reports Positive Clinical Results For Omnipod Horizon, Limited Market Release Of Dash https://bit.ly/2J0Ajd4
ADA2018: Senseonics' Implantable CGM Beats Abbott, Dexcom In Head-To-Head Study – But Is Methodology Flawed? https://bit.ly/2lXXBr6
ADA2018: Medtronic Touts Power of Artificial Intelligence, New Pediatric Indication, Payer Guarantee Program https://bit.ly/2KNXZGB
GE Spins Off Healthcare As Part Of Major Reorganization https://bit.ly/2tylKbJ
Bio-Techne Makes Big Push Into Liquid Biopsy With Exosome Acquisition https://bit.ly/2NuiJBZ
Novartis Sees The Light And Plumps For Alcon Spin-Off https://bit.ly/2u9qxjo
On this week's podcast, we discuss medtech matters that US lawmakers have on their radars, and issues that are coming up in the courts. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Learn more about the Medtech Insight Awards and enter nominations: https://bit.ly/2tMcQYD.
Medtech Insight articles addressing topics discussed in this episode: bioMérieux America CEO Talks Dx Reform Progress, Antibiotic Resistance: https://bit.ly/2yQBBHQ Servicing Company Points To Downsides In Third-Party Servicing Bill: https://bit.ly/2tLZiv2 Q&A: Ongoing Mishaps From Bad Device Fixes Argue For Third-Party Servicing Bill, Bayer Exec Says: https://bit.ly/2MWMTgR Bills Calling For Non-Pharma Alternatives To Opioids Clear US House: https://bit.ly/2tGWccD Market Intel: Peripheral Nerve Stim Players Edge Out Innovative Paths: https://bit.ly/2NdRuvg Patent Office Judge Suing Medtronic For Wrongful Termination: https://bit.ly/2KuTJIQ Boston Scientific Wins Pelvic Mesh Bellwether: Boston Scientific Wins Pelvic Mesh Bellwether
Informa Pharma Intelligence’s head of content Mike Ward and Generics Bulletin editor Aidan Fry discuss how US market pressures are making life tough for the generics industry.
On this week's podcast, we provide a roundup of recent guidance documents issued by US FDA on topics including humanitarian use devices to off-label communications. We also discuss the Medtech Insight Awards. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.
Learn more about the Medtech Insight Awards and enter to win: https://bit.ly/2HqAuxv
Medtech Insight articles addressing topics discussed in this episode: US FDA Tackles HDE 'Probable Benefits' Question In Draft Guidance: https://bit.ly/2l55mec US FDA Encourages Broader Use of Popular IVD Coding Standard, Cautions Off-Label Use: https://bit.ly/2KbvHCu FDA Finalizes Q&A Guidance Docs On Manufacturer Communications, Adding A Few More Details: https://bit.ly/2HKmU8vm Guidewire, Catheter Draft Guidance Docs Address Coating Risks: https://bit.ly/2tBUeJZ Calling A Q-Sub: New Guidance On Seeking Feedback From FDA: https://bit.ly/2KaJPz0
Listen to this podcast with Generics bulletin editor Aidan Fry and deputy editor David Wallace to find out: · Tips to write a nomination that gets noticed · How else you can be involved in the awards including complementary tickets · The benefits of sponsoring
In this edition of Device Week, Medtech Insight’s Tina Tan and Catherine Longworth discusses the trends in M&A and venture fundraising activity seen this year so far. They touch on what areas are getting the most interest from investors and strategic buyers, and the most recent deals worth noting.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
VC Deals Analysis: Positive Exit Markets Keep Venture Investment Swell Growing M&A Analysis – Acquisitions Come What May
In this week's podcast, we discuss the upcoming Medtech Insight Awards, digital health learnings, an uptick in Homeland Security alerts on device cybersecurity and a nascent US FDA program to improve use of standards in pre-market submissions.
Listen to the podcast via the player below
Links and Medtech Insight articles addressing topics discussed in this episode: Medtech Insight Awards https://bit.ly/2HqAuxv (Deadline for entries is June 22) Medtech Design In The Age Of Digital Health: Mindsets Have To Change, Flex Executive Says https://bit.ly/2M8q75l US Homeland Security Sees Rapid Growth In Device Cybersecurity Vulnerability Reports https://bit.ly/2JpGF6W FDA Issues Challenge To Medtech To Fight Opioid Crisis https://bit.ly/2Jp3Yh6 Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot https://bit.ly/2JDLBbF
Alexandra Shimmings, Executive Editor (Europe, Commercial) for Scrip, Pink Sheet and In Vivo. Joins Mike Ward, Chief Content Officer at Datamonitor Healthcare & Scrip Intelligence to deliver a preview of the 14th Annual Scrip Awards.
Entries are now open for the 14th Annual Scrip Awards. Since they began, the Scrip Awards has sought to applaud the essential role that the pharmaceutical, biotech and other allied industries play in improving healthcare. Its trophies span the entire range of industry activities, from new drug launches and clinical trials, to innovative deals, outsourcing and fundraising.
This year, we have introduced a new category – Best Use of Real-World Evidence – to reflect the growing importance of real-world evidence to the sector in understanding the value of drugs in the market and not just the highly controlled environment of the clinical trial.
Over the past 13 years, The Scrip Awards has carved out a unique place in the industry calendar, with around 500 attendees coming from around the world to the prestigious ceremony, which this year will take place in the London Hilton on Park Lane in Mayfair on 28 November.
Enter Here: https://pharmaintelligence.informa.com/events/awards/scrip-awards-2018
Mike Ward, the Global Head of Content at Informa, Pharma Intelligence Insights and Alex Shimmings, Executive Editor (Europe, Commercial) for Scrip, Pink Sheet and In Vivo. Present a preview of the the 14th Annual Scrip Awards.
This year, we have introduced a new category – Best Use of Real-World Evidence – to reflect the growing importance of real-world evidence to the sector in understanding the value of drugs in the market and not just the highly controlled environment of the clinical trial.
Over the past 13 years, The Scrip Awards has carved out a unique place in the industry calendar, with around 500 attendees coming from around the world to the prestigious ceremony, which this year will take place in the London Hilton on Park Lane in Mayfair on 28 November.
The deadline for entries is June 1. Now is the time to prepare your entry and make sure you take your place among the best.
ENTER HERE: https://pharmaintelligence.informa.com/events/awards/scrip-awards-2018
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In this week’s podcast, part 2 of our multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed. Author Shawn M. Schmitt explains what happens when a device-maker is appraised using the Capability Maturity Model Integration (CMMI) model and method, from the first intake calls to the last day of the assessment, when the final appraisal results are given to a firm.
Medtech Insight articles addressing topics discussed in this episode: • Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised https://bit.ly/2K6TWRV • Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites https://bit.ly/2jGPlL1
Two months into the job, MDIC CEO Pamela Goldberg talks about the organizations work running the NEST Coordinating Center, early feasibility studies and its work with US FDA on Case for Quality.
On this week's podcast, Shawn M. Schmitt talks about his first story in a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. An ongoing US FDA pilot program – which uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method – is discussed.
Medtech Insight articles addressing topics discussed in this episode: • Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites https://bit.ly/2jGPlL1 • Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised https://bit.ly/2K6TWRV
On this week’s podcast, Marion Webb reports on emerging exoskeleton technology to help patients recovering from spinal cord injuries or stroke, and Catherine Longworth reports on BioTrinity 2018 in London, a gathering of investors and medtech innovators.
AdvaMed Accel's Martha Shadan and Ashley Wittorf sat down with Medtech Insight to talk about their lobbying priorities for medtech start-ups and small businesses.
Former longtime US FDA official Kim Trautman, now with NSF International, sat down with Medtech Insight at MedCon 2018 for a podcast interview to discuss an array of industry issues, including the burgeoning Medical Device Single Audit Program, international regulatory convergence, FDA's percolating plan to replace the Quality System Regulation with ISO 13485, what keeps her up at night (hint: it's EU's new Medical Device and IVD Regulations), and other important issues that device-makers need to keep a sharp eye on.
On this week's podcast, Sue Darcey talks about some key takeaways from FDA Commissioner Scott Gottlieb's appearance at the Medical Device Manufacturers Association conference in Washington, DC, including some assurances on combination-product and pain-control-device reviews.
US FDA released a working model for their digital health pre-certification program as part of a broader Digital Health Action Plan. FDA's Bakul Patel spoke to Medtech Insight about what the agency is hoping to achieve with the new model.
In this edition of Device Week, Tina Tan chats to Elizabeth Orr on recent patent rulings, one related to an ongoing battle between TAVR rivals Boston Scientific and Edwards Lifesciences and another related to the broader area of challenging patent judgements. She also speaks to David Filmore to find out more details about CMS’s annual hospital inpatient proposal which it has just issued and how the new reimbursement rates would impact industry.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Here are a couple of other Medtech Insight articles related to patent rulings and reimbursement:
Boston Sci Wins Latest TAVR Patent Dispute Against Edwards https://protect-us.mimecast.com/s/ZLUJCgJxkgiAGxZMgHyZzZ1?domain=medtech.pharmaintelligence.informa.com
Orthopedists Asked CMS To Stop Mandatory Bundled-Pay Models https://protect-us.mimecast.com/s/8M--CjRvnlfnRMQW6SY1Le1?domain=medtech.pharmaintelligence.informa.com
In this week’s Medtech Insight podcast, we discuss US FDA Commissioner Scott Gottlieb’s big plan to boost medical device safety and quality, important news regarding cybersecurity, and the latest on a Medtronic clinical trial.
In this edition of Device Week, Tina Tan speaks to Catherine Longworth on Israel's push to become a global leader in digital health and Marion Webb on how science fiction is becoming reality in the operating room as surgeons take up technologies such as virtual, augmented and mixed reality to bring real benefits to patients.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: Israel On Quest For Digital Health Domination https://medtech.pharmaintelligence.informa.com/articles/2018/04/10/israel-on-quest-for-digital-health-domination Market Intel: When Reality Techs Kick In - How VR, AR And MR Are Revolutionizing Surgery https://medtech.pharmaintelligence.informa.com/articles/2018/04/03/market-intel-when-reality-techs-kick-in--how-vr-ar-and-mr-are-revolutionizing-surgery
After a meeting of FDA experts convened to talk about capillary blood glucose meters used in hospitals, Courtney Lias, division director of Chemistry and Toxicology Devices spoke to Medtech Insight about her takeaways.
On this week's podcast, Shawn Schmitt discussed his recent reporting on US FDA warning letter trends, including a record-low letter count last year and what might be contributing.
Medtech Insight articles addressing topics discussed in this episode: FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack https://bit.ly/2q39s8M
During the wait between the CMS NTAP town hall in February and the proposed rule on which products will receive an add-on payment, expected in April, Prevision Policy analysts Laura Helbling and Ramsey Baghdadi share their thoughts on drugs seeking NTAPs, recommendations by BIO and the Alliance for Regenerative Medicines to modify NTAP for regenerative medicines, and FDA’s stance that its Breakthrough and RMAT designations don’t mean the agency has determined a drug is an improvement over existing therapy.
On this week's podcast, we discuss Brexit. UK and EU leaders announced some progress on Brexit this week, establishing a conditional transition period after the UK exits the Union in 2019. But that does not resolve many questions and concerns in the medtech space of what's to come. Here is a deep dive into where things stand. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.
Medtech Insight articles addressing topics discussed in this episode: Brexit To Force Large-Scale Review Of Medtech Contractual Arrangements Throughout EU: https://bit.ly/2HSXJko UK Medtechs Stress Need To Get It Right On Brexit As Prime Minister Addresses EU: https://bit.ly/2ueVhTw One UK Notified Body To Be Phased Out This Year As It Moves To Sweden: https://bit.ly/2G1puqz MedTech Europe CEO Shakes Up Industry On Brexit In Mission To Help It: https://bit.ly/2pwoeEU Prepping For Brexit With Notified Body Switch Could Be Unnecessary Expense, BSI Warns: https://bit.ly/2pyokMm
A podcast discussion of three broader precedents stemming from the original Exondys 51 approval.
On this week's Device Week podcast, we discuss the medtech scene in Israel, the state of the glaucoma-therapy field, and the latest venture capital investments in medtech.
Alderley Park, one of the UK's leading bio and life science campuses, has just hosted a new conference, Accelerating Cancer Drug Development - From Target to Patients. At the event Mike Ward spoke to two of SMEs based at the site in Cheshire about the challenges of growing a business in the oncology supply chain.
On this week's podcast, we discuss medtech policy developments at several federal agencies, including the US Centers for Medicare and Medicaid Services, the Federal Trade Commission, FDA and the US Patent and Trademark Office. For more information on Medtech Insight and to start a free trial, click here: bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
US CMS Coverage Office Reorganizes In Effort To Improve Efficiency http://bit.ly/2FvGtAY Contact Lens Proposals From US Trade Commission To Be Scrutinized This Week http://bit.ly/2oXuIx2 Brain Trust Advises US FDA On Aneurysm Device Trials http://bit.ly/2oJZl9d Neuro Panel Takeaways: Detailed Responses On Aneurysm Devices From US FDA Advisors http://bit.ly/2DfNJ21 A Post-IPR World Would Hold Patent Risks And Benefits For Medtech Companies http://bit.ly/2FAGGGD
FDA Commissioner Scott Gottlieb has been most effective, room for improvement, and what would make for a second successful year.
Medtronic's Stacey Pugh talked to Medtech Insight after FDA's Neurological Devices Advisory Panel met to talk about how intracranial aneurysm devices should be evalauted in clinical trials. While she didn't find anything surprising about the panel's recommendations, she says it gives industry more clarity and consistency about the direction they need to take.
In this edition of Device Week, Medtech Insight’s Reed Miller and Marion Webb discuss what medtech’s role is in combatting rheumatoid arthritis and highlights some of the recent clinical trial initiations and completions.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode:
Bioelectronics, Imaging Fortify Medtech's Defense Against Rheumatoid Arthritis Starts & Stops: Abbott, Boston Scientific Head List Of Early 2018 Trial Announcements
Following a major Supreme Court patent case in 2014 that set a test for what is and is not patentable subject matter, medical device companies struggling to protect their software that is often considered not patentable. In this podcast we discuss the legal hurdles and what companies can do to push back.
This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 13th installment – the second of two parts – former FDA investigations branch director Ricki Chase brings you the latest insights into the complexity surrounding combination device/drug products. In this podcast, Chase digs deep into design control, design changes, human factors studies and biocompatibility concerns for combo products. She also discusses some pre- and post-market considerations, as well as common pitfalls to avoid.
In this edition of Device Week, Medtech Insight’s Reed Miller chats to Marion Webb about the most interesting presentations by the key spinal cord stimulation players at this year’s NANS meeting in Las Vegas, and also finds out from Tina Tan how the venture financing climate has been for start-ups in January.
For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Medtech Insight articles addressing topics discussed in this episode: NANS 2018: Positive Data Intensifies Spinal-Cord Stim's Big-Four Rivalry https://medtech.pharmaintelligence.informa.com/articles/2018/02/05/nans-2018-positive-data-intensifies-spinalcord-stims-bigfour-rivalry VC Deals Analysis: 2018 Off To A Flying Start https://medtech.pharmaintelligence.informa.com/articles/2018/02/09/vc-deals-analysis-2018-off-to-a-flying-start
This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 12th installment – the first of two parts – former FDA investigations branch director Ricki Chase brings you the latest insights into the complexity surrounding combination device/drug products. In this first podcast, Chase reviews regulations and guidance documents related to combo products. She also highlights the varying types of combo products, definitions unique to device design, and how combo product manufacturers differ from the typical medical device or drug firm.
On this week's podcast, we discuss US Congress' last-minute budget deal that included several Medicare provisions relevant to the medtech sector. And we also talked about US FDA's recent two-day workshop on its Pre-Cert Pilot Program for digital health.
Medtech Insight articles addressing topics discussed in this episode: • Medtech Provisions Approved In US Budget Agreement: http://bit.ly/2H2dWEh • Coming Together On Pre-Cert: Digital Health World Engages With FDA To Hash Out Regulatory Future: http://bit.ly/2Et48F0 • DC Reflections: Mark Leahey On MDMA's 2018 Priorities And The Medtech Landscape: http://bit.ly/2EbSLls
In a phone interview with Medtech Insight, MDMA CEO Mark Leahey talked about the industry group's ongoing efforts to fully repeal the medical device tax, 2018 priorities, the emerging digital health sector and more.
US FDA, industry and other stakeholders huddled at NIH for a two-day workshop at the end of January that resulted in deep discussions around how the agency should implement its Pre-Cert Program for software as medical devices. In an exclusive with Medtech Insight, CDRH's Bakul Patel explained the purpose of the confab was to understand how companies realistically operate so they can build the program with those considerations in mind.