Datamonitor Healthcare Analyst Podcast: Recent Episodes

Informa Pharma Intelligence Podcast

Round table discussion format focusing on recent events in the healthcare space, published monthly by thought leaders at Informa Pharma Intelligence.

https://pharmaintelligence.informa.com/

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Zach McLellan, Tara Hansen, Tom Tyler, and David Dahan discuss notable presentations and data releases from the 2020 ESMO meeting.

Topics covered in this episode include:

• LEAP-005: Lenvima + Keytruda in solid tumors (1:25)

• Phase III IPATential150 data: ipatasertib in mCRPC (5:59)

• Phase III - JAVELIN HEAD AND NECK 100: Bavencio (12:12)

• Phase III - IMpassion131 and IMpassion130: Tecentriq in TNBC (17:40)

• Phase III - CheckMate 649: Opdivo in gastric cancer + oesophageal cancer (22:52)

• Phase III - CROWN trial: Lorbrena vs. Xalkori in NSCLC (30:20)

To learn more about Datamonitor Healthcare, Biomedtracker, and other offerings from Informa Pharma Intelligence, visit:

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Zach McLellan, Tara Hansen, Tom Tyler, and David Dahan discuss notable presentations and data releases from the 2020 ASCO meeting.

Topics covered in this episode include:

• TIGIT + PD-L1: Tiragolumab w/ Tecentriq for NSCLC (:45)

• Phase III ADAURA trial update: adjuvant Tagrisso for NSCLC (5:10)

• JAVELIN Bladder 100 - Bavencio as maintenance therapy in urothelial carcinoma (10:00)

• Final OS data from TIVO-3 unlikely to lead to US approval for Tivopath in RCC (14:27)

• Phase II Pevonedistat-2001 trial: Pevonedistat for AML/MDS(19:05)

• Phase I/II EVOLVE study: orva-cel for mutliple myeloma (25:05)

• CodeBreak 100 - AMG510 update (32:54)

• ADP-A2M4 SPEAR T cells in solid tumors (38:45)

To learn more about Datamonitor Healthcare, Biomedtracker, and other offerings from Informa Pharma Intelligence, visit:

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Derek Burkhard and Mike Ramirez discuss notable big pharma full-year 2019 presentations.

Topics covered in this episode include:

• Overall company performance of Merck, Roche, AstraZeneca, Gilead, Sanofi, and GlaxoSmithKline (1:00)

• Current spin-offs & rationale (20:49)

• Discussion on notable big pharma M&A deals, and companies that may be looking to engage in M&A in the near future (27:49)

• China revenues, growth, and the potential impact of COVID-19 (36:42)

To learn more about Datamonitor Healthcare, Biomedtracker, and other offerings from Informa Pharma Intelligence, visit:

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Jessica Merrill, Andrew McConaghie, and Mike Ramirez discuss key takeaways from the 2020 J.P. Morgan Healthcare Conference (JPM).

Topics covered in this episode include:

• Intro/general discussion of the meeting (0:00-4:17)

• Focus on execution at this year’s meeting (4:17-6:14)

• Companies that may be poised to make M&A deals in the near future (6:14-9:05)

• Potential reasons behind lack of M&A, including uncertainty around the U.S. election, valuation expectations (9:05-16:49)

• Discussion on drug pricing regulation (16:49-23:31)

• Sessions of particular interest (23:31-34:24)

To learn more about Scrip, Pink Sheet, Datamonitor Healthcare and other offerings from Informa Pharma Intelligence, visit:

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Mandy Jackson, David Dahan, Tara Hansen, and Mike Ramirez preview abstracts of interest related to the American Society of Hematology (ASH) annual 2019 meeting.

Topics covered in this episode include:

• Mandy Jackson: Discussion of key presentations in the CAR-T space (1:35)

• David Dahan: Results from late-breaking abstract 3 (LBA3) on CC-486 in acute myeloid leukemia, review of LBA6 on a triple combination of Darzalex, Kyprolis and dexamethasone in multiple myeloma (8:02)

• Tara Hansen: Examination of sutimlimab for cold agglutinin disease (LBA2), as well as Blincyto in B-cell acute lymphoblastic leukemia (LBA1) (17:52)

• Mike Ramirez: Updated results for BELLINI trial in t(11;14) multiple myeloma patients, discussion on LBA5 detailing a BCL11A-silencing cell therapy approach for sickle cell disease (26:43)

To learn more about Scrip, Pink Sheet, Datamonitor Healthcare, BioMedTracker, and other offerings from Informa Pharma Intelligence, visit:

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Pammy Spicer, Amanda Micklus, and Mike Ramirez discuss current events in the healthcare space in the Informa Pharma Intelligence Podcast.

Topics covered in this episode include:

• Pammy Spicer: Biogen's stunning resurrection of aducanumab moves the anti-amyloid antibody from futility to FDA filing for Alzheimer’s (0:47)

• Amanda Micklus: Quick news round of a select key items in the cell and gene therapy sector, including Zolgensma’s and Yescarta’s Q3 sales and Zalmoxis’s withdrawal from the market (18:58)

To learn more about Datamonitor Healthcare, BioMedTracker, and other offerings from Informa Pharma Intelligence, visit:

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Mike Ramirez, Zach McLellan, David Dahan, and Tara Hansen discuss takeaways related to the European Society for Medical Oncology annual 2019 meeting.

Topics covered in this episode include:

• Mike Ramirez: Discussion of results for AMG 510 in colorectal cancer, as well as updates in first-line non-small cell lung cancer for Tecentriq, Opdivo, and Tagrisso (1:17)

• Zach McLellan: PARP inhibitors dual in ovarian cancer, including updates on Zejula, Lynparza, and veliparib (17:41)

• David Dahan: Phase II results for Debio 1143 combined with chemo-radiotherapy for patients with head and neck cancer and for tucatinib combined with Herceptin for patients with HER2+ colorectal cancer (27:47)

• Tara Hansen: Overview on Keytruda in triple-negative breast cancer, combination regimens in hepatocellular carcinoma, and new mechanism of action drugs in renal cell carcinoma (36:00)

To learn more about Datamonitor Healthcare, BioMedTracker, and other offerings from Informa Pharma Intelligence, visit:

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Hannah Cohen and Mike Ramirez discuss current events in the healthcare space in the Informa Pharma Intelligence Podcast.

Topics covered in this episode include:

• Mike Ramirez: Discussion around the Tumor Mutational Burden (TMB) biomarker and results from AstraZeneca’s NEPTUNE trial and Bristol-Myers Squibb’s CheckMate-227 trial (0:53)

• Hannah Cohen: Insights into Intercept’s Ocaliva as the first potential disease-specific therapy for the treatment of NASH and pricing strategies between payers and manufacturers (15:49)

To learn more about Datamonitor Healthcare, BioMedTracker, and other offerings from Informa Pharma Intelligence, visit:

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Louisa Joseph, Astrid Kurniawan, and Mike Ramirez discuss various proposals related to drug pricing under the Trump administration.

Topics covered in this episode include:

• Louisa Joseph: Discussion around the withdrawal of the Medicare Part D rebate proposal, and the recent Senate Finance Committee’s bill for lowering prescription drug costs (1:17)

• Astrid Kurniawan: International Pricing Index of Medicare Part B drugs and its market implications (13:39)

To learn more about Datamonitor Healthcare, BioMedTracker, and other offerings from Informa Pharma Intelligence, visit:

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Hardik Patel, Zach McLellan, and Mike Ramirez discuss takeaways related to the American Society for Clinical Oncology annual 2019 meeting.

Topics covered in this episode include:

• Mike Ramirez: Discussion of the ASCO 2019 presentation centered on the potential of STK11/KEAP1 mutations as a predictive biomarker for checkpoint inhibitors in NSCLC (0:57)

• Hardik Patel: Overview of several failed confirmatory trials for PD-1/PD-L1 inhibitors, including KEYNOTE-062, KEYNOTE-240, CheckMate 459, and EAGLE (12:00)

• Mike Ramirez: Refocus on targeted therapies in NSCLC at ASCO 2019, highlighting AMG 510, capmatinib, tepotinib, BLU-667, and TAK-788 results (23:37)

• Zach McLellan: Spotlight on the use of real-world evidence in ASCO 2019 presentations (38:46)

To learn more about Datamonitor Healthcare, BioMedTracker, and other offerings from Informa Pharma Intelligence, visit:

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David Dahan, Zach McLellan, and Mike Ramirez preview notable presentations related to the upcoming American Society for Clinical Oncology annual 2019 meeting.

Topics covered in this episode include:

David Dahan • AstraZeneca’s late breaking abstract will present the first numerical results for POLO, a Phase III trial evaluating Lynparza as single-agent maintenance therapy for frontline, BRCA mutant pancreatic cancer after platinum chemotherapy. In February 2019 AstraZeneca announced that POLO met its primary endpoint of improvement in progression-free survival. Here, we discuss the landscape for PARP inhibitors for pancreatic cancer and what’s next for Lynparza. (1:26) • Forty Seven will present early data from a Phase Ib trial in AML and MDS of 5F9, a macrophage checkpoint inhibitor. Updates for 5F9 in DLBCL and follicular lymphoma are expected at EHA. Here, we compare 5F9’s activity in DLBCL with Roche’s polatuzumab vedotin and MorphoSys’ MOR208. (6:01)

Zach McLellan • Data from the Phase III ANNOUNCE trial will provide color on the surprise failure of Lartruvo in sarcoma. (11:53) • Positive OS results for Kisqali in the MONALEESA-7 trial could help boost uptake in HR+/HER2- breast cancer. (16:28) • Strong OS data for Xtandi in the ENZAMET trial will help it keep pace with current and future next-generation hormone therapies in prostate cancer. (21:34)

Mike Ramirez • Context for the late-breaking presentation that will show more details on the EV-201 trial, testing enfortumab vedotin in bladder cancer. (27:03) • Discussion on the late breaking presentation for KEYNOTE-062, and competitive landscape in first-line gastric cancer (33:13) • Thoughts around initial Phase I data for AMG 510, a small molecule KRAS inhibitor, in NSCLC and colorectal cancer. (38:15)

To learn more about Datamonitor Healthcare, BioMedTracker, and other offerings from Informa Pharma Intelligence, visit:

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Dominique Fontanilla, Laurie Withington, Stephanie Yip, Pammy Spicer, and Mike Ramirez discuss current events in the healthcare space in the Informa Pharma Intelligence Podcast.

Topics covered in this episode include:

  • Clinical trial data from AAN are highlighted for Biogen’s Spinraza, Novartis’ gene therapy Zolgensma, and Roche’s risdiplam in spinal muscular atrophy. In addition, discussion points included in this segment are the potential market competition between the three drugs, differentiating factors, and possible barriers to uptake. (1:46)

  • Data presented on a new class of oral CGRP receptor antagonists by Allergan with ubrogepant and atogepant, in acute and episodic migraine respectively, as well as Biohaven’s rimegepant (ODT and tablet) in acute migraine. Efficacy and safety data are analyzed between the drugs, as well as currently approved treatments, as the companies approach filing and/or approval for acute migraine treatment. (18:55)

  • Long-term data showing sustained effects from the PROMISE-1 and PROMISE-2 trials investigating Alder BioPharmaceuticals’ lead drug candidate, eptinezumab, as a preventive for migraine. Eptinezumab’s competitive position within the context of marketed anti-CGRPs and other traditional preventive migraine therapies is discussed. (35:09)

  • A comparative discussion of neuromyelitis optica spectrum disorder candidates Soliris, satralizumab, and inebilizumab are discussed in the context of sub-group results presented at AAN. (51:21)

To learn more about Datamonitor Healthcare, Citeline, and other offerings from Informa Pharma Intelligence, visit:

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Find out how to write an entry for the MedTech Insight Awards.

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Pammy Spicer, Molly Nelson, Joe Haas, and Mike Ramirez discuss current events in the healthcare space in the Informa Pharma Intelligence Podcast.

Topics covered in this episode include:

  • Failure of aducanumab: Pammy Spicer discusses the high-profile failure of aducanumab, as well as the impact on the amyloid hypothesis, the mainstream concept underlying Alzheimer’s disease for over 20 years (1:39)

  • Preview of Meddevicetracker report on device regulatory timing: Molly Nelson shares insights from an upcoming report dissecting time to approval for medical devices through different approval pathways and therapeutic areas (19:51)

  • Recent results for Ocaliva (OCA) in non-alcoholic steatohepatitis (NASH): Joe Haas discusses recent results surrounding OCA, the reaction from the investment community, and the competitive landscape in NASH, a disease with no FDA-approved therapies (33:41)

To learn more about Datamonitor Healthcare, MedDeviceTracker, Scrip, Pinksheet, In Vivo and other offerings from Informa Pharma Intelligence, visit:

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Mandy Jackson, Mike Ramirez, and Stephanie Yip discuss current events in the healthcare space in the Informa Pharma Intelligence Podcast.

Topics covered in this episode include:

  • Bristol-Myers Squibb and Celgene merger: overview and latest developments of one of the largest pharma deals ever, as well as the pushback from institutional investors (1:37)
  • Selinexor PDUFA for multiple myeloma delayed: discussion of selinexor’s registrational filing for a highly refractory population of hematological cancer patients (16:18)
  • Approval of Spravato: analysis of the approval of a nasal spray formulation of esketamine for treatment resistant depression (28:47)

To learn more about Datamonitor Healthcare, Scrip, Pinksheet and other offerings from Informa Pharma Intelligence, visit:

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Zach McLellan, David Dahan, and Mike Ramirez discuss data from the ASH conference in this Datamonitor Healthcare Analyst Podcast.

Topics covered include:

  • New approvals for AML (Daurismo, Venclexta, Xospata) – 0:30
  • ASH results from BCMA-directed therapies – 12:25
  • JCAR017 and CTL119 in CLL – 25:05

To learn more about Datamonitor Healthcare and our offerings, visit: pharmaintelligence.informa.com/products-…ealthcare

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Zach McLellan and Mike Ramirez discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Tecentriq Priority Review in TNBC $RHHBY – 0:35
  • NKTR-214 & Opdivo data in melanoma $NKTR $BMY – 9:40
  • SynthorX IPO – 23:25

To learn more about Datamonitor Healthcare and our offerings, visit: pharmaintelligence.informa.com/products-…ealthcare

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Zach McLellan and Astrid Kurniawan discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Lynparza's strong maintenance data from SOLO-1 $AZN $TSRO $CLVS – 0:50
  • PI3K inhibitor alpelisib surprises with positive SOLAR-1 data $NVS – 7:54
  • Update on the Trump administration's plans to reduce drug costs – 15:22

To learn more about Datamonitor Healthcare and our offerings, visit: pharmaintelligence.informa.com/products-…ealthcare

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Zach McLellan, Michael Haydock, and Mike Ramirez discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Vital Therapies fails PIII retry $VTL – 0:45
  • ARO-HBV promising early-phase data in HBV $ARWR $GILD $RHHBY $JNJ – 7:15
  • cOAlition S. pact for open access of publicly funded research – 23:00

To learn more about Datamonitor Healthcare and our offerings, visit: pharmaintelligence.informa.com/products-…ealthcare

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Zach McLellan, David Dahan, and Amanda Miklus discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Yescarta and Kymriah reach the EU, but challenges remain (GILD NVS) - 0:42
  • Xerava approval for intra-abdominal infections (TTPH MRK AGN) – 13:13

To learn more about Datamonitor Healthcare and our offerings, visit: pharmaintelligence.informa.com/products-…ealthcare

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Zach McLellan and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Is the FDA getting PD-1 fatigue? (BMY MRK AZN RHHBY REGN) - 0:41
  • Preview of MARINER trial readout (JNJ BAYR PTLA) - 7:12
  • Opdivo approval in SCLC (BMY) - 15:00
  • Novo Nordisk acquisition of Ziylo (NOVO) - 19:54
  • Approval of Lenvima in HCC (ESALY) - 28:33

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Oliver Spray discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Overview of Gilead and AbbVie Q2 earnings releases (GILD ABBV) - 0:39
  • Post Q2 earnings PCSK9 market update (AMGN SNY REGN) - 16:25
  • Outlook for Portola Q2 earnings release (PTLA) - 23:25
  • CDK-4/6 inhibitor Q2 earnings review (PFE NVS LLY) - 26:25
  • Commentary surrounding Q2 Tymlos sales ahead of Radius earnings (RDUS) - 31:20

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Zara Fulton discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Nature Biotechnology paper raises questions about safety of CRISPR (CRSP EDIT NTLA) - 0:31
  • Discussion of Datamonitor Healthcare’s report on under the radar buyout targets – linked below (AMAG Medigene ALDR DNLI ACOR PTLA) - 9:50

To access the full report on under the radar takeout targets (subscription required), visit: https://service.datamonitorhealthcare.com/hkc/company/hot-topics/article194703.ece

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Oliver Spray discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Tecentriq meets primary endpoint in IMpassion130 trial for TNBC (RHHBY MRK AZN) - 0:31
  • Top-line results from the INDIGO trial of gemcabene (GEMP) - 10:54
  • Aimovig approval and CGRP market overview (AMGN LLY TEVA ALDR BHVN AGN) - 19:36

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Astrid Kurniawan discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. Topics covered include:

  • Topline results from ARREST trial of aramchol in NASH (GLMD) - 0:38
  • Health and Human Services Secretary Alex Azar’s plans for reducing drug prices (XBI IBB BIB) - 14:15
  • Topline results from Sarepta’s microdystrophin gene therapy program (SRPT SLDB PFE) - 22:23

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan and Jack Allen are joined by guest analyst Maria Berezina. The group discusses key recent events that occurred at the American Society of Clinical Oncology 2018 Annual Meeting. Topics covered include:

  • Challenges in developing PD-1 combinations: LAG525, ECHO-301 trials (NVS IMMP INCY) - 0:50
  • When PD-1 blockade is inferior to SOC: Keytruda in MM (KEYNOTE-183/185) & Tecentriq+chemo in 1L NSCLC (IMpower131) (MRK RHHBY PFE BMY) - 17:00
  • Failure of taselisib in the SANDPIPER trial (RHHBY NVS PFE AZN) - 32:53

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan and Jack Allen are joined by guest analysts Dominique Fontanilla and Hardik Patel. The group discusses key recent events that occurred at the American Society of Clinical Oncology 2018 Annual Meeting. Topics covered include:

  • LOXO-292 positive clinical trial data (LOXO) - 0:50
  • Updated results from the Phase I trial of bb2121 (BLUE CELG) - 8:55
  • NKTR-214 PIVOT-02 data from the expansion cohorts (BMY NKTR) - 17:32
  • Phase Ib/II trial results from Hu5F9-G4 in r/r NHL (Forty Seven, Inc., GILD NVS CELG) - 29:20

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • Approval of Yonsa in prostate cancer (SUNPHARMA JNJ) - 0:30
  • Broad market commentary (TSRO GILD CLVS PTLA BMY CELG) - 7:45

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Cameron Findlater discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • Analysis of volanesorsen advisory committee meeting - (AKCA IONS) - 0:28
  • Approval of AndexXa for reversal of Eliquis and Xarelto (PTLA BMY PFE BAYR) - 8:13
  • Eli Lilly announces acquisition of ARMO Biosciences (LLY ARMO MRK BMY NKTR) - 17:50

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • Results from QUADRA trial of Zejula in ovarian cancer (TSRO CLVS AZN) - 0:37
  • ADC Therapeutics drops one of their lead ADC drugs - 7:21
  • Earnings week in review (AMGN LLY RDUS MDCO BIIB ABBV GILD BMY PTLA) - 11:04

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Michael Ramirez discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • Novartis purchases AveXis - (AVXS NVS BIIB) - 0:30
  • Results from the ECHO-301 trial of epacadostat in melanoma (INCY NLNK BMY MRK)- 7:37
  • KEYNOTE-042 results of Keytruda in PD-L1 positive NSCLC patients (MRK BMY RHHBY) - 17:24

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • Allogene in-licenses TALEN (originally developed by Cellectis) technology from Pfizer (CLLS PFE) - 0:30
  • New data for NeuVax/Herceptin combination in breast cancer (SLS RHHBY)- 10:45
  • MediciNova announces early termination of Phase 2 trial of MN-001 in NASH/NAFLD based on positive data (MNOV) - 17:40

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Zach McLellan, Jack Allen, and guest analysts Louisa Joseph and Michael Haydock discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • ODYSSEY CVOT results of Praluent - (SNY REGN AMGN) - 0:39
  • Phase III trial results from patients who switched to Biktarvy from ABC/3TC/DTG (GILD GSK)- 19:47
  • US approval of Trogarzo (TH) - 31:33
  • Phase II results from a study of MOR208 in DLBCL (MOR) - 41:28

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Dan Chancellor discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • Analysis of the Sangamo Therapeutics and Gilead/Kite partnership for allogeneic oncology products (SGMO GILD CLLS CRSP NTLA EDIT) - 0:49
  • Celgene receives RTF letter from FDA with respect to ozanimod in MS (CELG NVS)- 14:12
  • Update on Restasis patent disputes (AGN) - 31:50
  • Earnings takeaways – PARP overview and Portola FDA communication surrounding the need for a randomized clinical trial of AndexXa (AZN TSRO CLVS PTLA) - 36:30

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • 2018 BIO CEO conference recap - 0:35
  • Phase IIb results of aramchol in HIV-lipodystrophy NAFLD or NASH patients (GLMD)- 13:11
  • Approval of Ereleada (apalutamide) in non-metastatic castration-resistant prostate cancer (JNJ PFE) - 20:15
  • Analysis of Bristol-Myers Squibb and Nektar Therapeutics collaboration for development of NKTR-214 (BMY NKTR) - 29:00

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Ines Mihel discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • Amazon, JP Morgan, and Berkshire Hathaway announce "profit-free" health insurance plans (AMZN JPM BRK) - 1:25
  • Potential acquisitions predictions (PTLA CLVS BMY)- 13:29
  • Highlights from Q4 earnings in the I&I space (NVS JNJ ABBV TKPYY) - 15:35
  • Bellicum's announcement of BPX-501 clinical hold (BLCM) - 26:00

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen, and guest analyst Dustin Phan discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

  • Results from the KN-189 trial of Keytruda in NSCLC (MRK BMY RHHBY AZN) - 0:45
  • Zytiga patent invalidation (JNJ PFE ALPMY) - 13:20
  • Celgene potential acquisition of Juno (CELG JUNO BLUE) - 19:45

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

This episode of the podcast features a roundtable discussion of potential deals prior to the JPM Healthcare Conference. Companies discussed as potential acquisition targets include Clovis Oncology (CLVS), Tesaro (TSRO), The Medicines Company (MDCO) Portola Pharmaceuticals (PTLA), Cellectis (CLLS), Sangamo Therapeutics (SGMO) bluebird bio (BLUE), and Juno Therapeutics (JUNO), while key acquirers outlined include Bristol-Myers Squibb (BMY), Roche (RHHBY), Gilead (GILD), AstraZeneca (AZN), Pfizer (PFE), Johnson&Johnson (JNJ), and Bayer (BAYRY). The episode wraps up with a discussion of Bristol-Myers Squibb's crucial CHECKMATE-227 trial in non-small cell lung cancer (NSCLC) and potential implications for the NSCLC market (MRK mentioned).

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Jack Allen and David Dahan discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Results from bluebird bio’s anti-BCMA CAR T (BLUE CELG JUNO GILD) - 0:43 - 6-month results from the JULIET trial (NVS GILD JUNO) - 8:36 - Results from Imbruvica+Venclexta in CLL (ABBV RHHBY) - 19:56

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Kevin Shannon and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - MDCO divestiture of ID business/Repatha sBLA update (MDCO AMGN) - 0:35 - Amgen migraine data (AMGN TEVA) - 8:20 - Bavencio Phase III gastric failure (PFE MRK BMY) - 16:40

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Kevin Shannon and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Cellectis UCART19 ASH abstracts (CLLS) - 0:35 - Juno JCAR017 ASH abstracts in r/r DLBCL (JUNO) - 12:20 - CDK-4/6 inhibitors sales review (PFE NVS LLY) - 22:15 - bluebird bio LentiGlobin ASH abstract review (BLUE) - 26:13

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Kevin Shannon and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Restasis patent update (AGN) - 0:40 - Yescarta approval in r/r DLBCL (GILD KITE) - 9:57 - Semaglutide advisory committee meeting (NVO) - 23:00 - Lynparza review in breast cancer (AZN) - 31:07

Apologies for the brief technical difficulties we will be working to find a more efficient recording method for the next episode, we appreciate your patience and support

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Kevin Shannon and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Impact of updates to Afrezza label (MNKD) - 0:35 - EU PARP development update (TSRO AZN) - 10:10 - Forward looking Q4 catalysts (CLLS AMGN SNY REGN GILD PTLA FGEN) - 20:33

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Kevin Shannon and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Sotagliflozin INTANDEM 3 results (LXRX SNY) - 0:30 - ProstVac Phase III failure (BVNRY BMY) - 9:10 - Patisiran APOLLO trial results (ALNY ABUS MDCO IONS) - 14:00 - Recent Ocaliva liver toxicity issues (ICPT GILD GNFT) - 19:40

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Kevin Shannon, Jack Allen and Ines Mihel discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - CAR T catch-up - Gilead purchase of Kite, Kymriah approval (GILD, KITE, NVS) - 0:32 - Cellectis UCART123 clinical hold (CLLS) - 10:00 - Eli Lilly update on baricitinib development (LLY INCY) - 15:50 - Fitusiran clinical hold(ALNY) - 24:04

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Zach McLellan, Kevin Shannon and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Review of PARP ICER report (AZN, TSRO, CLVS, PFE) - 0:37 - Market impact of semaglutide’s SUSTAIN 7 trial results (NVO, LLY) - 11:16

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Zach McLellan, Kevin Shannon and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Kite Therapeutics (KITE) axicabtagene ciloleucel development update - 0:34 - Review of recent data from oral statin add-on therapies bempedoic acid (ESPR) and gemcabene (GEMP)- 4:47 - Fibrogren (FGEN) and Galapagos (GLPG) data readouts in idiopathic pulmonary fibrosis - 12:01 - PARP second quarter earnings review (AZN, TSRO, CLVS, PFE)- 16:50

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Zach McLellan, and newest member Kevin Shannon discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Keytruda (MRK) does not meet primary endpoint in head and neck cancer - AstraZeneca's (AZN) MYSTIC trial failure with Infinzi - Serepta (SRPT)beats sales estimates - Biogen (BIIB)'s Spinraza beats sales estimates

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Jack Allen, and Zach McLellan discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Theme music produced by the podcast's very own Jared Wolff (www.soundcloud.com/jlwproductions)

Topics covered in this episode include: - Amicus Therapeutics' (FOLD) Galafold updated submission guidance from the FDA (0:48) - Novartis (NVS) CAR-T ad-comm meeting results (6:30) - Round table quick takes (13:34): - Array (ARRY) submits two NDAs for binimetinib and encorafenib - Tesaro (TSRO)- still a buyout candidate? - Rumors AstraZeneca (AZN) CEO on the move to Teva (TEVA)

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Jack Allen, and Zach McLellan discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Theme music produced by the podcast's very own Jared Wolff (www.soundcloud.com/jlwproductions)

Topics covered in this episode include: - Positive results for anacetrapib (ana) from CVOT (MRK) (0:52) - ARIEL3 trial data in ovarian cancer - a PARP story (CLVS, TSRO, AZN)(6:07) - Bevyxxa (betrixaban) approval for prophylaxis of VTE (PTLA) (13:56)

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Jack Allen, and Zach McLellan discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Overview of data from Novartis's JULIET trial: CAR-T impact (KITE & JUNO) (0:45) - Betrixiban's June 24th PDUFA (Portola) in prophylaxis of VTE (8:00) - Effect of Xtandi (Pfizer/Astellas) PROSPER trial amendments on prostate cancer market dynamic (Zytiga -JNJ mentioned) (15:12) - Scott Gottlieb's agenda as FDA commissioner: Five major policy points and the opioid epidemic (19:40)

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff and Zach McLellan discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: - Tesaro buyout rumors and analysis - Keytruda's approval in decentralized tumors with MSI-H and DMMR biomarkers - Cyramza's positive data in bladder cancer - does it stack up against I/O?

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Zach McLellan, and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast. This week, we are covering some selected abstracts released in front of the ASCO conference in June.

Topics covered in this episode include: - APHINITY trial of Roche's Perjecta+Herceptin combination in HER2+ breast cancer and readthrough to Puma's prospects (1:13) - OlympiAD trial - the first pivotal Phase III trial of a PARP inhibitor (AstraZeneca; Lymparza) in breast cancer (4:33) - Lenvima's (Eisai) quantitative data for first-line hepatocellular carcinoma (10:12) - MONARCH 2 data for abemaciclib - Eli Lilly's CDK4/6 with strong efficacy in HER+ breast cancer (14:30) - AbbVie's veliparib Phase III failure in breast cancer (18:30) - Keytruda (Merck)+chemotherapy releases encouraging data in triple-negative breast cancer (22:10) - IDOs: combinations with PD-(L)1 checkpoint inhibitors and looking forward to a new immunotherapeutic approach to oncology (Incyte; epacadostat, NewLink; indoximod) (26:44)

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Zach McLellan, and Jack Allen discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Special thanks to Dustin Phan for joining us this episode all the way from California! Dustin covers both bladder and non-small cell lung cancer for Datamonitor Healthcare.

Topics covered in this episode include: Tecentriq's (Roche) Phase III failure in bladder cancer (0:40) Keytruda's (Merck) label expansion for chemotherapy combo in first line NSCLC (14:03)

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Zach McLellan, Jack Allen, and Maha Elsayed discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in this episode include: Stivarga's (Bayer/Amgen) approval in second-line HCC (0:43) Approval of Radius Health's Tymlos for the treatment of osteoporosis (7:53) Neurotrope's Phase II data for Bryostatin-1 (14:43) Companion diagnostics: discussion of where they are now and where they will be in the future (24:43)

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Zach McLellan, Jack Allen, and Maha Elsayed discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Special thanks to Kevin (Kayj) Shannon for joining us on the podcast this week! Kayj is a cardiovascular and metabolic diseases analyst for Datamonitor Healthcare who is based in San Diego, CA.

Topics covered in this episode include: Epidiolex’s role as a cannabinoid treatment for pediatric epilepsy (0:36) Puma Biotechnology's niratinib upcoming advisory committee meeting (7:15) CRL issued to Eli Lilly and Incyte for baricitinib in rheumatoid arthritis (14:27) Discussion of key second quarter market catalysts for Radius Health, Intercept Pharmaceuticals, FibroGen, and Cara Therapeutics (23:21)

To learn more about Datamonitor Healthcare and our offerings, visit: https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare

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Jared Wolff, Zach McLellan, Jack Allen, and Maha Elsayed discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

This week we have a special guest joining us! Dan Chancellor is the Lead Analyst for Central Nervous System and Rare Diseases at Datamonitor Healthcare.

Topics covered in this episode include: - CAR-T Overview: Novartis’s accelerated approval for CTL-019 and Kite’s updated trial data for KTE-019 (0:43) - Approval of Tesaro's Zejula in both BRCA and non-BRCA mutated ovarian cancer patients (9:06) - Approval of Roche's Ocrevus relapsing in primary progressive forms of multiple sclerosis (17:50)

To learn more about Datamonitor Healthcare and our offerings, visit:

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Jared Wolff, Zach McLellan, Jack Allen, and Maha Elsayed discuss current events in the healthcare space in the Datamonitor Healthcare Analyst Podcast.

Topics covered in our second episode include: A PARP inhibitor overview with data from the SGO (0:36) Array Biopharma's withdrawal of binimetinib from FDA review (7:50) NKTR-181's positive Phase III data - an opioid painkiller (13:54) ACC 2017 conference coverage - Repatha (Amgen) FOURIER CVOT data, ORION-1 inclisiran (The Medicines Company) Phase II data (20:10)

SGO, PARP, Lynparza, Zejula, Rubraca, olaparib, niraparib, rucaparib, ovarian cancer, astrazeneca, Tesaro, Clovis, AZN, TSRO, CLVS, Array, binimetinib, FDA, NKTR-181, opioid, painkillers, ACC, Repatha, Amgen, FOURIER, CVOT, ORION-1, inclisiran, Medicines company, MDCO

To learn more about Datamonitor Healthcare and our offerings, visit: pharmaintelligence.informa.com/products-…ealthcare

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Jared Wolff, Zach McLellan, Jack Allen, and Maha Elsayed discuss current events in the healthcare space in the Pharma Intelligence Analyst Podcast.

Topics covered: Juno discontinuation of lead candidate, JCAR-015 (0:17) Kite positive ZUMA-1 6-month data readout in NHL(4:40) Perjeta and the impact of the Phase III APHINITY trial (10:30) Emicizumab's hemophilia safety event (Roche) (15:44) Buyout talk (22:40) Juno, JCAR015, Kite, ZUMA1, NHL, Perjeta, APHINITY, emicizumab, hemophilia, Roche, Genetech, cancer, CAR-T, immumo-oncology, oncology, buyout, Herceptin, breast cancer, adjuvant

There are plenty of products available on the following link https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/datamonitor-healthcare