DocTalk: Recent Episodes

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Get your health care new fix here on DocTalk, the flagship series from HCPLive delivering updates and interviews on breaking news in medicine every week.

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In this episode of Joint Ventures, hosts Jack Arnold, MBBS, PhD (academic clinical lecturer in rheumatology, University of Leeds), and Rihards Buss, MD (consultant rheumatologist, Freeman Hospital, Newcastle), record a post-EULAR 2026 debrief, working through the abstracts each identified as the meeting's most consequential. The conversation spans cellular therapies in autoimmune disease, proteomic biomarkers for treatment selection in RA, a landmark head-to-head trial in psoriatic arthritis, evolving classification criteria for axial spondyloarthritis, and the first phase III randomized controlled trial of a JAK inhibitor in polymyalgia rheumatica.

Studies featured in this episode include:

AB-101 Allogeneic NK Cell Therapy in Rheumatologic Diseases (LB0003)
CARLYSLE: Obe-Cel CAR T in Severe Refractory SLE (OP0341)
Ex Vivo Proteomic Signatures of JAK and TNF Inhibitors Predict Treatment Response in RA (OP048)
BE BOLD: Bimekizumab vs Risankizumab in PsA (LB0001)
2025 ASAS-SPARTAN Revised AxSpA Classification Criteria (OP0236, OP0239, POS0190, POS1341)
JAK-SPARE: Baricitinib in Early Polymyalgia Rheumatica (LB0005)

Click here to read more and watch the full video at RheumatologyLive.

Could hepatitis B finally have a finite treatment option? Tatyana Kushner, MD, joins hosts Nancy Reau, MD, and Kimberly Brown, MD, to break down the phase 3 B-Well data for bepirovirsen, the first agent to hit functional cure as a primary endpoint in chronic hepatitis B.

The conversation covers the phase 3 B-Well 1 and B-Well 2 results, published in the New England Journal of Medicine and presented at EASL 2026, and why quantitative HBsAg testing is becoming essential to patient selection ahead of a potential approval. Kushner, Reau, and Brown also work through what functional cure actually means for patients, how it compares to spontaneous HBsAg loss, and what dosing and monitoring are likely to look like given signals for ALT elevation and renal effects seen in the trials. They discuss which patients are unlikely to be candidates, including those with cirrhosis or decompensated liver disease, and close with a look at what an approval could mean for hepatitis B screening rates and referral patterns between primary care and specialty hepatology.

Bepirovirsen is not yet FDA approved. The FDA has accepted the New Drug Application for priority review, with a PDUFA goal date of October 26, 2026.

For more: https://www.hcplive.com/view/liver-lineup-bepirovirsen-and-the-push-toward-functional-cure-in-hepatitis-b

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Kimberly Brown, MD (Henry Ford Hospital), and Nancy Reau, MD (Rush University Medical Center), are joined by Tatyana Kushner, MD (Weill Cornell Medicine), to discuss hepatitis delta virus (HDV).

Topics covered:
Why fewer than 10% of HBsAg-positive patients have ever been tested for HDV — and why that needs to change
The diagnostic cascade from HDV antibody to HDV RNA, and barriers to reflex testing implementation
The recent FDA approval of bulevirtide (Livdelzi) for chronic HDV infection, including dosing, administration, and the combination vs. monotherapy question
10 mg vs. 2 mg dose considerations and off-treatment response data
Phase 3 pipeline

For more: https://www.hcplive.com/view/liver-lineup-hdv-diagnosis-bulevirtide-and-the-delta-pipeline

In this episode of Joint Ventures, host Rihards Buss, MD, consultant rheumatologist, Freeman Hospital, Newcastle, sits down with Sarah Dyball, MBBS, PhD, academic clinical lecturer, Centre for Musculoskeletal Research, University of Manchester, and Kate Harnden, MBChB, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, at the European Alliance of Associations for Rheumatology (EULAR) 2026 annual congress in London.

Click here to watch the episode.

The therapeutic framework for systemic sclerosis is undergoing a fundamental reorientation, moving away from managing visible fibrotic sequelae toward targeting the autoantibody-driven mechanisms believed to initiate and propagate disease.

On a recent episode of Joint Ventures recorded live at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London, host Jack Arnold, MBBS, PhD, of the University of Leeds, spoke with Vishal Kakkar, MD, also of the University of Leeds and a specialist in scleroderma, about the most consequential data emerging from the congress.

Click here to watch the episode.

In this episode of Joint Ventures, hosts Jack Arnold, MBBS, PhD, academic clinical lecturer in rheumatology, University of Leeds, was joined at the European Alliance of Associations for Rheumatology (EULAR) 2026 annual congress in London by Laurence Duquenne, MD, a rheumatology researcher, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, an investigator on one of the meeting's standout studies to examine whether baseline naïve CD4+ T cell frequency can identify which newly diagnosed patients with rheumatoid arthritis (RA) are unlikely to respond to methotrexate monotherapy, and whether adding a biologic at the outset can close that gap.
Click here to watch the episode.

In this episode of Joint Ventures, hosts Jack Arnold, MBBS, PhD, an academic clinical lecturer in rheumatology at the University of Leeds, and Rihards Buss, MD, a consultant rheumatologist at Freeman Hospital, Newcastle, preview their unofficial countdown of the sessions, themes, and abstracts they are most excited about heading into the 2026 European Alliance of Associations for Rheumatology (EULAR) Annual Meeting in London, June 3–6, including: * Obesity, Weight Management, and Psoriatic Arthritis Sessions * Personalized Medicine and Biomarkers in RMDs Sessions * Fatigue and Quality of Life in Connective Tissue Disease Session * Mitochondrial DNA and Interferon: Upstream Drivers of Autoimmunity Session * Artificial Intelligence and Pattern Recognition in Rheumatology Sessions * Axial Imaging in Axial Spondyloarthritis Session * Head-to-Head Superiority Trials in RA and PsA Sessions * CAR-T and CAR-NK Therapies: Efficacy, Limits, and What Comes Next Sessions

In the second part of this Joint Ventures episode on B cell therapies in rheumatic disease, hosts Jack Arnold, MBBS, PhD, and Rihards Buss, MD, return with guest Lucy Carter, MBBS, PhD, to move beyond the question of how to deplete B cells and toward the more conceptually challenging problem of what happens after depletion — and whether ianalumab's dual mechanism of action represents the most rational answer yet developed.

The episode examines the biologic rationale behind combining rituximab with belimumab, reviews the landmark NEPTUNUS Sjögren disease trials in which ianalumab became the first targeted therapy to meet a phase 3 primary endpoint in the disease, and discusses how emerging therapies may ultimately reshape treatment selection, steroid reduction strategies, and long-term management of autoimmune conditions including Sjögren disease and systemic lupus erythematosus.

In this episode of Joint Ventures, hosts Jack Arnold, MBBS, PhD, an academic clinical lecturer in rheumatology at the University of Leeds, and Rihards Buss, MD, a consultant rheumatologist at Freeman Hospital, Newcastle, are joined by guest Lucy Carter, MBBS, PhD, a consultant rheumatologist at Newcastle upon Tyne NHS Foundation Trust and honorary clinical senior lecturer at Newcastle University, to examine nearly 2 decades of B cell–targeted therapy in rheumatic disease — a story that has proven considerably more complicated than its early promise suggested.

Carter, Arnold, and Buss trace the mixed legacy of rituximab in lupus and Sjögren disease and examining how incomplete B cell depletion, BAFF-driven rebound, and trial design limitations may have contributed to disappointing early results. The discussion then turns to newer approaches such as obinutuzumab, whose positive REGENCY and ALLEGORY trial data in lupus nephritis and systemic lupus erythematosus suggest that deeper, more durable B cell depletion may improve outcomes, while emerging CAR-T data raise broader questions about the future role of intensive immune reprogramming in autoimmune disease.

In this episode of Joint Ventures, hosts Jack Arnold, MBBS, PhD, an academic clinical lecturer in rheumatology at the University of Leeds, and Rihards Buss, MD, a consultant rheumatologist at Freeman Hospital, Newcastle, turn from osteoarthritis to the inflammatory arthritides — examining what early data in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and lupus can and cannot yet tell us about the role of GLP-1 receptor agonists in disease modification.

“Everyone is talking about [GLP-1 RAs] and what it can do for our patients. Much more evidence is needed to be much more better understanding about increasing effects beyond weight loss is needed. And I think that evidence will be just coming out very rapidly, year by year… but I think this is not the case where we're going to wait for strong evidence, good quality RCT data before we start to start to use them,” Buss said.

In this episode of Joint Ventures, hosts Jack Arnold, MBBS, PhD, an academic clinical lecturer in rheumatology at the University of Leeds, and Rihards Buss, MD, a consultant rheumatologist at Freeman Hospital, Newcastle, examine the growing evidence for GLP-1 receptor agonists in rheumatological disease — drugs originally developed for glycemic control that are now drawing serious attention as potential immunomodulators with implications across the specialty.

The conversation opens by tracing the arc of GLP-1 agonist development, from exenatide's approval in 2005 through to semaglutide's landmark cardiovascular and renal data in the SELECT1 and FLOW2 trials, before turning to the question now quietly circulating in rheumatology clinics: are these drugs doing something beyond shifting weight?

In this episode of Joint Ventures, hosts Jack Arnold, MBBS, PhD, an academic clinical lecturer in rheumatology at the University of Leeds, and Rihards Buss, MBBS, a consultant rheumatologist at Freeman Hospital, dive into 2 emerging therapeutic strategies with the potential to reshape care for systemic lupus erythematosus (SLE) and psoriatic arthritis (PsA): Fc receptor blockade with nipocalimab and tyrosine kinase 2 (TYK2) inhibition with deucravacitinib, distinct pathways united by a shared goal of greater precision in immune modulation.

Introducing Joint Ventures — a new podcast exploring advances in rheumatologic disease and what they mean for real-world practice. Hosted by RheumatologyLive, the series is led by Jack Arnold, MBBS, PhD, and Rihards Buss, MBBS, 2 United Kingdom-based rheumatologists united by a shared interest in translating rapidly evolving science into thoughtful, patient-centered care.

Joint Ventures is designed for rheumatologists and clinicians managing immune-mediated disease who are navigating an increasingly complex therapeutic landscape. Each episode will examine emerging evidence, new mechanisms of action, and shifting paradigms in rheumatology, with a focus on how these developments intersect with clinical reasoning, uncertainty, and long-term patient management.

Arnold is an academic clinical lecturer in rheumatology at the Leeds Institute of Rheumatic and Musculoskeletal Medicine in University of Leeds, with research interests spanning systemic lupus erythematosus, clinical trials, and the application of deep learning in medicine. Buss is a consultant rheumatologist specializing in psoriatic arthritis at Newcastle’s Freeman Hospital, with a particular focus on integrating new data into day-to-day clinical decision-making.

Despite more than 14 approved therapies for Crohn's disease and ulcerative colitis, many patients still aren't reaching remission. At DDW 2026, David Rubin, MD, of the University of Chicago Medicine explains why the problem isn't the drugs — it's how and when we use them. He covers early treatment strategies, treat-to-target monitoring, the induction pitfall, and when to switch mechanisms rather than cycling within class.

Read more: https://www.hcplive.com/view/closing-the-gap-between-ibd-therapies-and-patient-outcomes-with-david-rubin-md

In this episode of Liver Lineup, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by Meena Bansal, MD, to examine how liver disease uniquely affects women across the lifespan. While conditions like metabolic dysfunction-associated steatotic liver disease (MASLD) are often discussed in broad terms, the trio highlights how risk, progression, and outcomes can differ significantly based on sex and hormonal status.

From reproductive years through menopause and beyond, physiologic changes play a central role in shaping liver health, but these distinctions have historically been underrecognized in both research and clinical care.

Key Episode Timestamps

0:00:00 – Welcome & women’s liver health framework
0:03:17 – Menopause, estrogen loss, and fibrosis risk
0:10:57 – PCOS, young women, and high‑risk metabolic phenotypes
0:13:54 – Pregnancy, MASH, and maternal-fetal outcomes
0:18:45 – Screening strategy, menopause as a pivot, and intervals
0:28:03 – Practical toolkit: FIB‑4, second‑line tests, and who to test
0:31:27 – Management, GLP‑1s, resmetirom, and key takeaways

https://www.hcplive.com/view/liver-lineup-closing-the-gap-in-women-s-liver-health

In this episode of Liver Lineup, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by Saul Karpen, MD, PhD, and Robert Gish, MD, for a practical, clinician-focused discussion on the evolving role of genetic testing in cholestatic liver disease.

As genetic panels become more widely used in hepatology, many clinicians are left wondering when to order these tests—and how to interpret the results when they come back. From unexplained cholestasis and AMA-negative PBC to intrahepatic cholestasis of pregnancy and atypical liver enzyme patterns, the conversation explores where genetic testing can add real clinical value.

Karpen and Gish break down the basics of modern genetic panels, including how they’ve evolved over time, what clinicians should look for in results, and how to approach common challenges like variants of uncertain significance (VUS). The discussion also highlights key genes, such as ABCB4 and ABCB11, and explains how genetic findings can influence diagnosis, risk assessment, and treatment decisions.

Read more: https://www.hcplive.com/view/liver-lineup-navigating-genetic-testing-in-cholestatic-liver-disease

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

RAINIER: Povetacicept Reduces Proteinuria By 52.0%
A pre-specified week 36 interim analysis of the phase 3 RAINIER trial found that povetacicept, a dual BAFF/APRIL inhibitor, reduced proteinuria by 52% from baseline and achieved a statistically significant 49.8% reduction in UPCR versus placebo in patients with IgA nephropathy.

Lorundrostat Secures FDA NDA Acceptance for Hypertension, Falls Short in Phase 2 OSA Trial
The FDA accepted Mineralys Therapeutics' NDA for lorundrostat as an add-on treatment for hypertension, supported by phase 3 and phase 2 trial data, with a PDUFA action date set for December 22, 2026.

Discontinuing GLP-1 Treatment Associated With Up to 60% Weight Regain, With Brajan Budini
New findings indicate that stopping GLP-1 receptor agonist therapy leads to a predictable pattern of weight regain—reaching approximately 60% at one year before plateauing—suggesting meaningful but substantially diminished long-term benefit after cessation.

FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment
The FDA approved GSK's leucovorin calcium tablets as the first treatment for cerebral folate deficiency in patients with a confirmed FOLR1 gene variant, based on a systematic review of published literature and mechanistic data.

New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children
Long-term data from the INTEGUMENT-OLE extension study show that once-daily roflumilast cream 0.05% is safe and well-tolerated in children aged 2 to 5 with mild-to-moderate atopic dermatitis, with efficacy not only sustained but continuing to improve through 56 weeks of treatment.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

MAJESTY: Obinutuzumab Achieves 2 Year Complete Remission in Primary Membranous Nephropathy
Obinutuzumab demonstrated superior complete remission rates at 2 years compared with tacrolimus in primary membranous nephropathy in the phase 3 MAJESTY trial, supporting a potential new B-cell–targeted standard of care.

Ixekizumab, Tirzepatide Effective Together for Psoriasis and Obesity or Overweight
In adults with moderate-to-severe plaque psoriasis and obesity or overweight, combination therapy with ixekizumab and tirzepatide achieved superior skin clearance and weight reduction at 36 weeks compared with ixekizumab alone.

AREXVY Vaccine Reduces Hospitalization, Major Adverse Cardiovascular Events in RSV
Real-world data from over 2.5 million patients showed GSK’s AREXVY vaccine was 75.6% effective against RSV-related hospitalization, with additional signals suggesting reduced in-hospital major adverse cardiovascular events in older adults.

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD
COMP360 synthetic psilocybin met the primary endpoint in its second phase 3 trial in treatment-resistant depression, demonstrating significant symptom reduction at week 6 versus low-dose control and advancing toward potential regulatory submission.

Thykamine Shows Disease-Modifying Potential in MASH Using Liver-on-a-Chip Platform
Preclinical data using a human liver-on-a-chip model suggest Thykamine may exert dose-dependent antifibrotic and anti-inflammatory effects in MASH, supporting further translational development.

Accurately defining the population of patients with short bowel syndrome (SBS) and intestinal failure has long been a challenge in gastroenterology.

In an effort to bring greater clarity to the field, Alan Buchman MD, MSPH, a professor of Clinical Surgery and Medical Director of the Intestinal Rehabilitation and Transplant Center at the University of Illinois at Chicago and director of gastroenterology at Elevance Health, led the introduction of new, more specific ICD-10-CM codes for SBS, along with corresponding updates to World Health Organization ICD-11 classifications.

His recent real-world US claims analysis presented at the ASPEN 2026 Nutrition Science and Practice Conference examined how widely those codes have been adopted and what that adoption, or lack thereof, reveals about disease burden and clinical practice.

Key Interview Time Stamps
0:00:00 What prompted this analysis of ICD code adoption in short bowel syndrome?
0:01:17 Key findings
0:03:33 Understanding reasons for variability in code adoption
0:04:36 The potential benefits of improved coding accuracy

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for February 1-7, 2026:
1. FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic Reactions
The FDA issued a Complete Response Letter for sublingual dibutepinephrine after identifying human factors issues that could compromise safe use during anaphylaxis, underscoring the importance of reliable administration in emergency settings.

Positive Topline Data Released on Roflumilast Cream in Infants with Atopic Dermatitis
Phase 2 data indicate roflumilast cream was well tolerated in infants with atopic dermatitis and showed early signs of clinical improvement, supporting potential expansion of topical PDE4 inhibition into this very young population.
FDA Accepts Resubmitted BLA for RelabotulinumtoxinA for Glabellar and Lateral Canthal Lines
The FDA accepted Galderma’s resubmitted BLA for relabotulinumtoxinA following manufacturing process updates, allowing regulatory review to resume for treatment of glabellar and lateral canthal lines.
Upadacitinib Regulatory Applications Submitted for Adults, Adolescents with Vitiligo
AbbVie submitted regulatory applications seeking to expand upadacitinib use to adults and adolescents with non-segmental vitiligo, positioning a systemic JAK inhibitor as a potential option for this underserved condition.
VESPER-3: Positive Results of Long-Term GLP-1 PF’3944 in Overweight and Obesity Without T2D
Positive phase 2b results suggest Pfizer’s long-acting GLP-1 receptor agonist may support sustained weight management with extended dosing intervals in patients without diabetes.

In this episode of Liver Lineup: Updates and Unfiltered Insights, Nancy Reau, MD, and Kimberly Brown, MD, turn their attention to metabolic dysfunction–associated steatotic liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH), conditions that now dominate hepatology clinics but continue to pose major diagnostic and therapeutic challenges. As new drugs enter the clinic and others advance through the pipeline, the hosts explore what meaningful progress looks like in a disease space defined by heterogeneity, comorbidities, and ongoing uncertainty around long-term outcomes.

Key episode timestamps:
0:00:00 – Intro + global MASLD burden and mortality; who progresses to severe liver disease.
0:03:00 – Very low disease awareness; advanced MASLD often missed.
0:06:32 – Weak FIB‑4–based referral patterns; need automated pathways.
0:10:54 – Alcohol underreporting; role of PEth in honest discussions.
0:15:18 – “Modest” alcohol still harmful in MASLD; no truly safe level.
0:19:40 – Semaglutide/GLP‑1 benefits on liver outcomes beyond weight loss.
0:23:22 – FGF‑21 agents improving portal hypertension in advanced disease.
0:24:03 – Carvedilol less effective for variceal bleed prevention in MASLD.
0:28:45 – Closing remarks; call for better disease control and systems of care.

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Nancy Reau, MD, and Kimberly Brown, MD, tackle a paradox that continues to define viral hepatitis care: despite curative therapies for hepatitis C and highly effective suppression for hepatitis B, global and domestic elimination goals remain out of reach. The conversation reframes viral hepatitis not as a “finished” chapter in hepatology, but as an ongoing public health challenge shaped by missed screening, gaps in linkage to care, and uneven adoption of evidence-based interventions.

Key episode timestamps:
0:00:00 – Hepatitis elimination gaps; dialysis-unit success; primary-care screening barriers.
0:04:30 – Statins in HBV/HCV: reduced HCC/decompensation; safety in compensated disease.
0:08:41 – GLP‑1 agonists: improved liver outcomes and cancer/cardiometabolic profile; safety concerns addressed.
0:13:21 – HBV functional cure and Bepi: niche role, durability, small but meaningful responder group.
0:19:28 – HBV/HDV: disease severity; new mAb + siRNA regimen; comparison with existing options; access issues.
0:23:28 – Bulevirtide durability data; real‑world compassionate-use case with recompensation and early HCC.

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Kimberly Brown, MD, and Nancy Reau, MD, break down new research on liver transplantation, hepatocellular carcinoma (HCC), and the ongoing evolution of surveillance strategies in chronic liver disease. Drawing on their extensive experience as transplant hepatologists, Brown and Reau place new data into practical context, highlighting where evidence may meaningfully inform practice and where unanswered questions remain.

Key episode timestamps:
0:00:00 – Introduction
0:00:19 – Frailty & Transplant Evaluation
0:02:54 – How Centers Use Frailty Measures
0:04:37 – Practicalities of the Six‑Minute Walk
0:06:10 – MELD 3.0 and Sex/Size Disparities
0:08:42 – Exception Points & Size Constraints
0:10:05 – Need for a Dynamic MELD System
0:10:19 – Immunotherapy as Bridge/Downstaging for HCC
0:13:34 – Real‑World Use of IO Around Transplant
0:15:22 – Managing Rejection Risk
0:19:03 – MASLD Population & Surveillance Gaps
0:20:21 – Adherence to HCC Surveillance
0:22:42 – Practical Barriers: AFP, Ultrasound, Radiology Reports
0:24:02 – Shift Toward Blood-Based Surveillance
0:26:01 – How AFP-L3 and DCP Are Used in Practice
0:27:39 – Rising AFP, Imaging Strategy & Broader Trend to Blood Tests
0:28:27 – Guidelines vs Real-World Practice
0:29:37 – Closing Thoughts on Guidelines & Early Detection

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Kimberly Brown, MD, and Nancy Reau, MD, break down several of the most consequential hepatology developments of 2025, focusing on practical advances in the management of patients with advanced liver disease. From renal protection in metabolic dysfunction-associated steatotic liver disease (MASLD) cirrhosis to long-debated questions around albumin dosing and emerging tools for monitoring hepatic encephalopathy at home, the discussion centers on how new data may begin to shift everyday clinical decision-making.

Key episode timestamps:
0:00:00 – Dapagliflozin in MASLD cirrhosis with ascites
0:04:41 – Clinical perspective on dapagliflozin & management strategy
0:06:37 – Albumin for hyponatremia in cirrhosis
0:12:28 – How clinicians currently use albumin in practice
0:18:43 – Low‑dose vs conventional‑dose albumin in high‑risk SBP
0:25:03 – Beacon device: at‑home critical flicker frequency for HE
0:27:47 – Future of at‑home HE monitoring & closing remarks

In this episode of Liver Lineup: Updates & Unfiltered Insights, hosts Nancy Reau, MD, and Kim Brown, MD, take on a recent consequential and controversial public health decision: the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices’ (ACIP) vote to remove the universal birth-dose hepatitis B vaccine recommendation for infants born to mothers who test negative for HBV.

Key episode timestamps:
0:00:00 – Introduction and initial reactions
0:01:40 – Hep B as an anti‑cancer vaccine & global perspective
0:03:59 – Transmission, testing gaps, and implementation problems
0:07:48 – Infant risk, carrier status, and long‑term protection
0:10:14 – Broader health and oncology implications
0:11:48 – Personal stance and closing thoughts

In this special edition episode of Liver Lineup, recorded as part of HCPLive's This Year in Medicine series, hosts Nancy Reau, MD, and Kimberly Brown, MD, break down the most consequential updates of the year across primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and autoimmune hepatitis (AIH), highlighting data that may reshape both near-term management and longer-term treatment strategies.

Key episode timestamps:
0:00:00 – Intro
0:00:40 – Underuse of second‑line therapy in PBC
0:03:40 – Long‑term data on PPAR agonists (elafibranor, seladelpar) in PBC
0:09:35 – PSC: elafibranor (Elmwood trial) and CCL24 mAb (nabokitug)
0:15:56 – Cholestasis symptoms: fatigue and pruritus and PPAR impact
0:20:20 – Autoimmune hepatitis: limitations of current therapy; new agent

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by guest Jessica Mellinger, MD, to discuss rising prevalence, new care models, and evolving concepts in alcohol-associated liver disease (ALD).

Key episode timestamps:
0:00:00 – Introduction
0:00:30 – Prevalence of alcohol use & ALD under-recognition
0:04:22 – Origin and design of the integrated ALD clinic
0:06:50 – Expansion and outcomes of integrated care
0:10:33 – Workforce and access challenges
0:12:21 – Metabolic ALD (MetALD) concept
0:15:18 – GLP‑1 agonists for metabolic disease & AUD
0:19:09 – “Food noise,” food addiction, and ultra‑processed foods
0:22:38 – Liver transplantation in ALD & Dallas criteria
0:27:27 – Outcomes after relapse & closing

In this episode of Liver Lineup: Updates & Unfiltered Insights, host Nancy Reau, MD, sits down with Kris Kowdley, MD, to discuss evolving approaches in cholestatic liver disease, with a particular focus on primary biliary cholangitis (PBC).

Key episode timestamps:
0:00:00 – Guest intro & evolution of PBC therapy
0:07:34 – Redefining biochemical response & earlier assessment
0:16:26 – OCA withdrawal & positioning PPARs/fibrates
0:22:16 – Diagnosing AMA‑negative PBC
0:25:58 – Genetic cholestasis panels & PFIC spectrum
0:29:45 – Symptom burden, pruritus, & IBAT inhibitors
0:35:17 – Bone health & closing remarks

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Nancy Reau, MD, and Kimberly Brown, MD, sit down with Mary (Maru) Rinella, MD, a professor of medicine and director of Clinical Trials and the Metabolic and Fatty Liver Program at the University of Chicago, to discuss the rapidly evolving therapeutic landscape for metabolic dysfunction-associated steatohepatitis (MASH).

Key Episode Timestamps:
0:00:00 – Introduction & guest bio
0:01:02 – Current therapy landscape & GLP‑1 overview
0:03:51 – Do GLP‑1s help non–weight losers?
0:05:21 – Combining GLP‑1s and resmetirom
0:07:23 – Pipeline GLP‑1 combinations & phase 2 data
0:09:26 – Advanced disease, sarcopenia & risk–benefit in cirrhosis
0:13:29 – Introduction to FGF‑21 agonists
0:14:04 – Symmetry (efruxifermin) trial & reading the data
0:17:51 – Endpoints, “lack of progression,” and FDA hurdles
0:19:41 – Need for non‑invasive surrogates
0:21:02 – FGF‑21 mechanism & other liver diseases
0:22:57 – Alcohol intake, GLP‑1s, FGF‑21 & MetALD
0:25:49 – 10‑year outlook & future toolbox
0:27:35 – Closing

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for January 18-24, 2025:
1. Phase 2 Data Show NS002 Intranasal Epinephrine Acts Faster Than EpiPen
Interim phase 2 data suggest NS002 intranasal epinephrine may provide more rapid systemic exposure than intramuscular autoinjectors, supporting its potential as a needle-free option for anaphylaxis management.

AHA 2026 Heart Disease and Stroke Statistics: Progress and Pitfalls, With Latha Palaniappan, MD, MS
The AHA’s 2026 Heart Disease and Stroke Statistics highlight persistent gaps in cardiovascular prevention and outcomes despite advances in treatment, with continued emphasis on heart disease and stroke as leading causes of mortality in the US.
New CHEST Recommendations Guide Biologic Use for Severe Asthma
CHEST released updated guidance to help clinicians individualize biologic selection for severe asthma based on patient characteristics, disease phenotype, and available evidence.
Topical Steroid Concerns in Dermatology Highlighted in Nationwide Survey
A nationwide survey underscores widespread patient and caregiver concerns about long-term topical steroid use in chronic inflammatory skin diseases and a perception that current management strategies are largely reactive rather than preventive.
Amlitelimab Effective, Safe for Atopic Dermatitis in Patients 12 Years and Older
Phase 3 data show amlitelimab was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis, supporting its role as a targeted, non–T-cell-depleting biologic option.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for January 11-17, 2025:
1. FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D
The FDA cleared Medtronic’s MiniMed Go Smart MDI app for pediatric and adult patients with type 1 or type 2 diabetes, enabling integrated smart pen and sensor–based decision support to improve insulin dosing with multiple daily injections.

2. FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD
The FDA approved ProlivRx as the first at-home, physician-directed neuromodulation therapy for adults with major depressive disorder who have not responded adequately to antidepressant treatment.

3. FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies
The FDA requested removal of suicidal ideation and behavior warnings from GLP-1 receptor agonist labels after determining there is no increased risk associated with these therapies.

4. FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis
The FDA extended the review timeline for sparsentan’s supplemental NDA in focal segmental glomerulosclerosis, delaying the PDUFA decision without requesting additional safety or manufacturing data.

5. FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates
The FDA approved new, more portable packaging for over-the-counter Narcan nasal spray to improve usability, reduce stigma, and increase the likelihood that naloxone is carried and available during overdose emergencies.

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Top 5 Healthcare Headlines for January 3-10, 2025:
Here are one-sentence, clinician-focused summaries with titles restated and no statistics included:

1. FDA Approves Caplacizumab-yhdp (Cablivi) as First Pediatric aTTP Therapy
The FDA approved caplacizumab for adolescents with aTTP, making it the first therapy specifically indicated for pediatric patients with this condition.

2. Pemvidutide Gets Breakthrough Therapy Designation for MASH
The FDA granted Breakthrough Therapy Designation to pemvidutide for MASH, supporting its accelerated development based on promising mid-stage clinical data and alignment on a registrational phase 3 program.

FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy
The FDA granted Priority Review to the BLA for atacicept, advancing a potential new biologic therapy for adults with IgA nephropathy.
FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen Deficiency
The FDA approved a higher-dose presentation of Fibryga, expanding dosing flexibility for fibrinogen replacement in patients with acquired fibrinogen deficiency.
FDA Accepts for Priority Review sBLA for Teplizumab for Children With Stage 2 T1D
The FDA accepted a Priority Review sBLA for teplizumab to expand its use to younger children in order to delay progression to clinical type 1 diabetes.

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Top 5 Healthcare Headlines for December 28-January 3, 2025:
1. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care
The FDA granted 510(k) clearance to StimLabs’ Theracor, marking the first umbilical cord–derived wound care device available in a sheet formulation.

2. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion
The FDA approved tradipitant as the first new pharmacologic option in decades for preventing motion sickness–related vomiting.

3. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism
The FDA issued a CRL for relacorilant, citing the need for additional evidence of effectiveness despite positive findings from completed trials.

4. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD
The FDA again declined approval of ONS-5010 for wet AMD, reiterating that confirmatory evidence of efficacy is required to support the application.

5. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation
The FDA accepted and granted Priority Review to the sNDA for AXS-05, advancing a potential new treatment option for agitation in Alzheimer’s disease.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for October 12-18, 2025:
1. FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes
The FDA accepted MannKind’s sBLA for Afrezza inhaled insulin to expand its use to children and adolescents with type 1 or type 2 diabetes.

2. FDA Approves Updated Indication for Upadacitinib (Rinvoq) in IBD
The FDA broadened upadacitinib’s indication to allow use in ulcerative colitis and Crohn disease when tumor necrosis factor blockers are not clinically appropriate.

3. FDA Clears First Blood Test to Rule Out Alzheimer-Related Amyloid Pathology
The FDA cleared Elecsys pTau181 as the first blood test to help rule out Alzheimer-related amyloid pathology in older adults with cognitive symptoms.

4. Digital Therapeutic Reduces Negative Symptoms of Schizophrenia in Phase 3 Trial
A phase 3 study showed a prescription digital therapeutic significantly reduced negative symptoms in schizophrenia when used alongside antipsychotic therapy.

5. APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint
Iptacopan demonstrated meaningful efficacy in slowing kidney function decline in adults with IgA nephropathy, supporting future regulatory submissions.

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Top 5 Healthcare Headlines for October 5-11, 2025:
1. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years
The FDA approved roflumilast cream 0.05% for mild to moderate atopic dermatitis in children aged 2–5 years, expanding Arcutis’ roflumilast portfolio.

Nerandomilast Nets First New FDA Approval for Idiopathic Pulmonary Fibrosis in Over 10 Years
Nerandomilast became the first newly approved therapy for idiopathic pulmonary fibrosis in over a decade, offering a well-tolerated option that slows lung function decline.
LUCENT-3: Mirikizumab (Omvoh) Shows Sustained Benefit in Ulcerative Colitis Through 4 Years
Long-term data confirmed mirikizumab provides durable clinical, endoscopic, and quality-of-life benefits for ulcerative colitis up to four years, even in patients who failed prior advanced therapy.
Bax24: Baxdrostat Achieves Primary Endpoint in Treatment-Resistant Hypertension
Baxdrostat met its primary endpoint in a phase 3 trial for treatment-resistant hypertension, supporting its potential role as a new option for difficult-to-control blood pressure.
Topical Bimiralisib Shows 92% Clearance Rate for Patients with Actinic Keratosis
Phase 2 data showed topical bimiralisib achieved high lesion clearance with favorable tolerability in patients with actinic keratosis.

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Top 5 Healthcare Headlines for September 28-October 4, 2025:
FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis
The FDA approved guselkumab as the first IL-23 inhibitor for children ≥6 years with moderate-to-severe plaque psoriasis or active psoriatic arthritis.

FDA Approves Remibrutinib for Chronic Spontaneous Urticaria
Remibrutinib, a selective BTK inhibitor, gained FDA approval for adults with chronic spontaneous urticaria based on sustained efficacy in phase 3 trials.

Novo Nordisk Resubmits Insulin Icodec (Awiqli) Injection BLA for Type 2 Diabetes
Novo Nordisk resubmitted its once-weekly insulin icodec BLA for type 2 diabetes after addressing prior FDA concerns.

Novo Nordisk Submits Denecimig (Mim8) BLA for Hemophilia A
Novo Nordisk filed a BLA for denecimig as prophylaxis for hemophilia A, supported by FRONTIER program data.

VESALIUS-CV: Evolocumab (Repatha) Achieves Primary Endpoints in Patients with ASCVD
Evolocumab reduced major cardiovascular events in ASCVD patients without prior MI or stroke in the phase 3 VESALIUS-CV trial.

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Top 5 Healthcare Headlines for September 5-September 14, 2025:
1. FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA
The FDA determined no advisory committee is needed for sparsentan’s sNDA in FSGS, which remains under review with a January 2026 decision date.

Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market
Intercept will withdraw obeticholic acid from the US PBC market after an FDA request and related clinical trial holds.
FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials
The FDA accepted a proposal to qualify FibroScan liver stiffness measurement as a surrogate endpoint for MASH trials, supported by multiple industry partners.
FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD
eGenesis received FDA clearance to begin clinical testing of a genetically engineered porcine kidney transplant in patients with ESKD.
First in Class Cat, Birch Allergen Blockers Succeed in Phase 3 Trials
Regeneron reported phase 3 success for novel allergen-blocking antibodies targeting cat and birch allergies, with confirmatory trials planned.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for August 31-September 5, 2025:
1. Mitapivat PDUFA for Thalassemia Delayed to December
The FDA extended the review timeline for mitapivat in thalassemia, with a new decision date set for December 2025.

Arcutis Submits sNDA for Roflumilast Cream 0.3% for Psoriasis in Children Aged 2-5 Years
Arcutis submitted an sNDA seeking to expand roflumilast cream’s indication to include plaque psoriasis in children as young as 2.
Zilebesiran, RNAi for Hypertension, Heads to Phase 3 Cardiovascular Outcomes Trial
Alnylam is advancing zilebesiran into a phase 3 outcomes trial to evaluate its impact on cardiovascular risk in patients with uncontrolled hypertension.
RestorAATion-2: WVE-006 Achieves Durable Serum AAT Protein Production in AATD
Wave Life Sciences reported durable serum AAT protein production with WVE-006 in AATD, supporting its potential for disease modification.
Phase 3 Data Show Amlitelimab Effective in Adults, Adolescents with Atopic Dermatitis
Sanofi announced phase 3 results showing amlitelimab improved disease severity and skin clearance in moderate-to-severe atopic dermatitis.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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FDA Accepts Priority Review Application of Omidubicel for Severe Aplastic Anemia
The FDA accepted a priority review application for omidubicel, a cell therapy under investigation for severe aplastic anemia.

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy
The FDA approved an updated REMS label for sparsentan, easing monitoring requirements for patients with IgA nephropathy.

FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMDThe FDA issued a complete response letter for ONS-5010 in wet AMD, citing insufficient efficacy evidence from the phase 3 program.

ACC Releases Respiratory Disease Vaccination Guidelines for Adults with Heart DiseaseThe ACC released new guidance recommending vaccination against respiratory infections for adults with cardiovascular disease to improve prevention and access.

Orforglipron Delivers Weight Loss, A1C Reductions in Phase 3 ATTAIN-2 TrialEli Lilly reported phase 3 results showing orforglipron improved weight and glycemic control in adults with obesity or overweight and type 2 diabetes.

In this podcast, expert Suneel Udani, MD, discusses the management of chronic kidney disease (CKD) and CKD-associated fluid overload, including an overview of treatment guidelines and various available therapies.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for August 17-23, 2025:
1. FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks
The FDA approved donidalorsen (DAWNZERA) for preventing HAE attacks in patients 12 years and older, supported by phase 3 OASIS trial data.

FDA Grants Atumelnant Orphan Drug Designation for Congenital Adrenal Hyperplasia
Atumelnant received FDA Orphan Drug Designation after phase 2 results showed rapid, sustained reductions in key biomarkers for congenital adrenal hyperplasia.
Semaglutide Reduces Medical Costs, Healthcare Resource Utilization in Heart Failure
A real-world analysis found semaglutide 2.4 mg reduced all-cause medical costs by 28% and inpatient hospitalization costs by 55% in patients with obesity and heart failure.
RE104 Reduces Postpartum Depression Symptoms by Day 7 in Phase 2 RECONNECT
RE104 significantly reduced depressive symptoms by day 7 in patients with postpartum depression, meeting the phase 2 RECONNECT trial’s primary endpoint.
Dyslipidemia, Other Metabolic Syndrome Factors May Raise Parkinson’s Disease Risk
People with metabolic syndrome had about a 40% higher risk of developing Parkinson’s disease compared with those without the condition.

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Top 5 Healthcare Headlines for August 10-16, 2025:FDA Approves 2 Generic Iron Sucrose Injections for Iron Deficiency Anemia in CKD
The FDA approved 2 generic versions of iron sucrose injection for treating iron deficiency anemia in patients with CKD, expanding access to therapy.

FDA Approves PharmaTher’s Ketamine for Surgical Pain Management
The FDA approved PharmaTher’s ketamine formulation for surgical pain management following resolution of earlier application deficiencies.

HFSA and ASPC Release Statement on Shifting to Prevention in Heart Failure
The HFSA and ASPC issued a joint statement urging clinicians to prioritize prevention and early risk management in heart failure care.

Zopapogene Imadenovec First Immunotherapy Approved for Recurrent Respiratory Papillomatosis
The FDA approved zopapogene imadenovec as the first immunotherapy for recurrent respiratory papillomatosis, offering a new treatment option.

AHA & ACC Release New Guidelines for High Blood Pressure to Reduce CVD Risk
The AHA and ACC released updated hypertension guidelines recommending earlier intervention to lower cardiovascular disease risk.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for August 3-9, 2025:FDA Approves Fremanezumab to Prevent Episodic Migraine in ChildrenThe FDA has expanded fremanezumab’s indication to include pediatric patients 6–17 years old, making it the first CGRP antagonist approved for preventing episodic migraine in this population.

ATTAIN-1: Orforglipron Achieves Up to 12% Weight Loss in Phase 3 Obesity Trial
Orforglipron, an investigational oral GLP-1 receptor agonist, met all primary and secondary endpoints in phase 3, supporting its potential as a weight-management therapy.

Oral Berotralstat Shows Strong Safety, Efficacy in Young Children with HAEInterim phase 3 data support oral berotralstat as a safe and effective prophylactic therapy for hereditary angioedema in children aged 2–11 years.

Aflibercept 8mg Noninferior to Aflibercept 2mg in Diabetic Macular Edema
Aflibercept 8 mg demonstrated noninferior visual acuity outcomes to 2 mg dosing in DME, with potential for reduced injection frequency.

Despite Advances, IBS Continues to Impact Patients' Daily Lives, Productivity
A new national survey reveals ongoing quality-of-life and productivity burdens among IBS patients despite greater awareness and expanded treatment options.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for July 7-13, 2025:FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More
Finerenone (Kerendia) was approved on July 14, 2025, to reduce cardiovascular death and heart failure hospitalizations in adults with HFmrEF or HFpEF, based on data from the FINEARTS-HF trial.

Baxdrostat Meets Efficacy Endpoint in Phase 3 Trial for Resistant Hypertension
In the phase 3 BaxHTN trial, baxdrostat significantly reduced systolic blood pressure in patients with resistant hypertension, supporting its potential as a first-in-class aldosterone synthase inhibitor.

FDA Approves Updated VARIPULSE Platform Irrigation Flow Rate for Heart Disease
The FDA approved an updated irrigation flow rate for the VARIPULSE Platform, which has been used in over 10,000 procedures with a reported neurovascular adverse event rate of less than 0.5%.

Palopegteriparatide Provides Sustained Response in Adults with Hypoparathyroidism
Palopegteriparatide showed durable 3-year improvements in biochemistries, kidney function, and quality of life across all forms of hypoparathyroidism in the phase 3 PaTHway trial.

FDA Grants Orphan Drug Designation to Taladegib, Potential Idiopathic Pulmonary Fibrosis Treatment
Taladegib received Orphan Drug Designation on July 16, 2025, as a potential treatment for idiopathic pulmonary fibrosis, currently being studied in the phase 2b WHISTLE-PF trial.

In this episode, hosts Kimberly Brown, MD, and Nancy Reau, MD, discuss the progress and persistent challenges in eliminating hepatitis C (HCV).

With highly effective, short-course oral therapies now available, Brown and Reau emphasize that curing HCV is more achievable than ever. The discussion explores the major policy, clinical, and structural milestones enabling this effort—and the critical gaps in diagnosis, treatment access, and health policy that still impede progress.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for June 30-July 6, 2025:Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema
The FDA approved sebetralstat (Ekterly) on July 7, 2025, as the first oral, on-demand treatment for hereditary angioedema attacks in patients aged 12 and older, backed by phase 3 KONFIDENT trial data.

Rilparencel Improves eGFR Slope in Phase 2 CKD, Diabetes REGEN-007 Trial
Rilparencel significantly slowed kidney function decline in CKD patients with diabetes in the REGEN-007 trial, showing dose-responsive eGFR slope improvements after two injections per kidney.

J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse
J&J filed a supplemental NDA for lumateperone after phase 3 data showed a 63% reduction in schizophrenia relapse risk compared to placebo.

FDA Publishes CRLs for Past Drug, Biological Product Applications
The FDA publicly released over 200 Complete Response Letters from 2020–2024 to increase regulatory transparency and help accelerate future drug approvals.

FDA Grants TSND-201 Breakthrough Therapy Designation for PTSDTSND-201 (methylone) received Breakthrough Therapy designation for PTSD on July 10, 2025, offering a potential rapid-acting alternative to SSRIs, which can take up to 12 weeks for full effect.

In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Roland Mattern, director of marketing for eSight, about the development and clinical potential of the eSight Go – a fifth-generation wearable low-vision device designed to enhance central visual function in patients with conditions such as macular degeneration, diabetic retinopathy, and Stargardt’s disease.

00:00 - Intro
02:06 - History of eSight
05:43 - Difference Between 4th and 5th Generation eSight Go
07:51 - Patient Experiences with the eSight Go
10:22 - Returning to Daily Life with the eSight Go
13:27 - Why Retina Specialists Don't Hear About the eSight Go
17:07 - Next Steps for eSight

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for June 16-22, 2025:Pemvidutide Shows Significant MASH Effects, Weight Loss at 24 Weeks in Phase 2b IMPACT TrialTopline phase 2b data show pemvidutide achieved significant rates of MASH resolution and fibrosis improvement alongside meaningful weight loss at 24 weeks, positioning it as a promising candidate for metabolic liver disease treatment.
FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus NephritisThe FDA approved a belimumab autoinjector for at-home subcutaneous use in children as young as five with active lupus nephritis, providing the first approved biologic self-injection option for pediatric SLE and LN.
Phase 3 Trial Results Announced for Sotatercept-csrk in Pulmonary Arterial HypertensionPositive phase 3 results show sotatercept-csrk added to background therapy reduced time to clinical worsening events in adults with PAH, supporting its potential as an effective treatment for this high-risk population.
Compass Pathways’ COMP360 Psilocybin Shows Benefit in Phase 3 TRD TrialCOMP360 psilocybin demonstrated a significant reduction in depression symptom severity in treatment-resistant depression, meeting the primary endpoint in a pivotal phase 3 trial.
Once-Monthly Obesity Drug, MariTide, Achieves Weight Loss Up to 16% at 1 YearPhase 2 data indicate once-monthly MariTide induces substantial weight loss of up to 16% over one year, with additional improvements in glycemic control, highlighting its promise for obesity and type 2 diabetes management.

In this episode of Medical Ethics Unpacked, hosts Dominic Sisti and Steve Levine welcome Jason Schwartz, PhD, associate professor at the Yale School of Public Health, for a discussion on vaccine ethics, public health infrastructure, and the challenges of maintaining trust in immunization programs.

Together, they explore how the COVID-19 pandemic reshaped public attitudes toward vaccines, while also underscoring long-standing tensions between individual autonomy and collective responsibility. Schwartz, whose work focuses on vaccine policy and history, offers perspective on the systems and institutions, such as the CDC's Advisory Committee on Immunization Practices (ACIP), helping to translate scientific evidence into public health recommendations.

This episode comes at a time when ACIP is once again in the headlines as HHS Secretary Robert F. Kennedy Jr. recently replaced all 17 members with a new slate of individuals, citing concerns about groupthink and conflicts of interest. The move has generated widespread commentary about the role and value of such expert advisory bodies in shaping public health decisions, especially in the face of growing skepticism and political scrutiny.

Ethical questions about equity, communication, and responsibility are threaded throughout the discussion. The hosts and Schwartz reflect on what it means to make fair vaccine recommendations in the context of incomplete data, and how institutions can maintain public trust amid scientific uncertainty. They also discuss how the infrastructure behind public health decisions—committees, advisory boards, and interagency coordination—can either strengthen or undermine confidence depending on how they function and how well they are understood.

Chapters
00:00 – Introduction and Vaccine Policy in Crisis
03:00 – The Long History and New Politics of Vaccine Skepticism
09:30 – Erosion of Public Health Infrastructure and Expert Advisory Systems
14:50 – Why Vaccines Became a Political Flashpoint
19:10 – Clinician Ethics and the Vaccine-Hesitant Patient
32:00 – Data, Misinformation, and the Future of Vaccine Trust

References:

Stone W. RFK Jr. names new slate of vaccine advisers after purging CDC panel. NPR. Published June 11, 2025. Accessed June 17, 2025. https://www.npr.org/sections/shots-health-news/2025/06/11/nx-s1-5430870/cdc-vaccine-experts-rfk-jr

Asturias EJ, Brewer NT, Brooks O, et al. Advisory Committee on Immunization Practices at a Crossroads. JAMA. Published online June 16, 2025. doi:10.1001/jama.2025.10776

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for June 2-8, 2025.FDA Approves Clesrovimab RSV Immunization for Newborns and Infants
The FDA has approved clesrovimab (Enflonsia) for the prevention of RSV lower respiratory tract disease in infants, based on results from two late-stage clinical trials evaluating its safety and efficacy.

FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCVThe FDA has expanded the indication for glecaprevir/pibrentasvir to include treatment of acute hepatitis C virus infection in adults and children aged three years and older, regardless of cirrhosis status.

FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular InflammationPrednisolone acetate ophthalmic suspension 1% has received FDA approval as a topical steroid treatment for steroid-responsive ocular inflammation, with product launch expected later in 2025.

FDA Grants Fast Track Designation to Mavorixafor for Chronic Neutropenia
The FDA has granted Fast Track designation to mavorixafor for the treatment of chronic neutropenia, supporting its ongoing phase 3 evaluation following earlier approval for WHIM syndrome.

Iptacopan (Fabhalta) Hits Primary Endpoint in Phase 3 APPULSE-PNH Trial
Phase 3 data show iptacopan (Fabhalta) is effective and well-tolerated in adults with PNH who transitioned from anti-C5 therapy, achieving key hematologic outcomes and symptomatic improvement.

In this episode of Liver Lineup: Updates & Unfiltered Insights, hosts Kimberly Brown, MD, a professor of Medicine at Michigan State University and Wayne State University, associate medical director of the Henry Ford Hospital Transplant Institute, and medical director of Transplant Outreach Services at Henry Ford Hospital, and Nancy Reau, MD, a professor of internal medicine, the Richard B. Capps Chair of Hepatology, associate director of solid organ transplantation, and the section chief of hepatology at Rush University Medical Center, continue their discussion on notable abstracts presented at the 2025 European Association for the Study of the Liver (EASL) Congress.

If you haven't already, be sure to check out part 1 here!Key Episode Timestamps

0:00:00 LITMUS Study

0:05:47 Norursodeoxycholic Acid in PSC

0:10:12 GLOBE Score for PBC

0:15:11 Conclusion

Arbutus, and VIR. Relevant disclosures for Brown include Mallinckrodt Pharmaceuticals, Gilead, Salix, Intercept, Ipsen, and Madrigal.

In this episode of Liver Lineup: Updates & Unfiltered Insights, hosts Kimberly Brown, MD, a professor of Medicine at Michigan State University and Wayne State University, associate medical director of the Henry Ford Hospital Transplant Institute, and medical director of Transplant Outreach Services at Henry Ford Hospital, and Nancy Reau, MD, a professor of internal medicine, the Richard B. Capps Chair of Hepatology, associate director of solid organ transplantation, and the section chief of hepatology at Rush University Medical Center, highlight 4 key abstracts presented at the 2025 European Association for the Study of the Liver (EASL) Congress.

Key Episode Timestamps

00:00:01 Introduction

00:00:45 Efimosfermin Alfa in MASH

00:05:56 PEth Testing

00:13:19 RETRACT-B

00:20:44 Linerixibat in PBC

Relevant Disclosures for Reau include AbbVie, Gilead, Salix, Arbutus, and VIR. Relevant disclosures for Brown include Mallinckrodt Pharmaceuticals, Gilead, Salix, Intercept, Ipsen, and Madrigal.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for May 12-18, 2025.
FDA Approves Once-Daily Roflumilast (ZORYVE) Foam 0.3% for Scalp and Body Psoriasis
The FDA approved once-daily roflumilast (Zoryve) foam 0.3% for treating plaque psoriasis on the scalp and body in patients aged 12 and older. This marks the fifth overall indication for roflumilast, adding to its existing approvals in psoriasis and atopic dermatitis.

FDA Warns About Rare, Severe Itching After Stopping Cetirizine or Levocetirizine
The FDA issued a warning about severe pruritus that can occur after stopping long-term cetirizine or levocetirizine use. Manufacturers will be required to add a label warning noting that symptoms may improve if the medications are restarted.

FDA Approves Susvimo for Treatment of Diabetic Retinopathy
The FDA approved Genentech’s Susvimo, a ranibizumab delivery system, as the first continuous refillable treatment for diabetic retinopathy. Susvimo offers sustained vision maintenance with refills needed only once every nine months.

Olezarsen Cuts Triglyceride Levels at 6 Months in Essence Study
The Essence study showed olezarsen significantly reduced triglyceride levels in patients with moderate hypertriglyceridemia at ASCVD risk. Monthly doses achieved about 60% reductions, with most patients reaching normal triglyceride levels after six months.

Ruxoprubart Shows Efficacy for PNH in Interim Phase 2 Trial Results
Interim Phase 2 results showed ruxoprubart met all primary efficacy endpoints in adults with paroxysmal nocturnal hemoglobinuria. The therapy led to transfusion avoidance, improved hemoglobin, reduced LDH, and increased PNH clone size at 12 weeks.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

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Top 5 Healthcare Headlines for May 5- 11, 2025:
FDA Accepts Sparsentan (Filspari) sNDA for Focal Segmental Glomerulosclerosis
The FDA will review Travere Therapeutics’ application for full approval of sparsentan in FSGS, with an advisory committee meeting planned ahead of a January 2026 decision.

FDA Accepts BioCryst’s NDA for Berotralstat Oral Granules in Children With HAE
The FDA is evaluating berotralstat oral granules for pediatric hereditary angioedema, which could become the first oral preventive therapy for children under 12.

SURMOUNT-5: Tirzepatide (Zepbound) Proves Benefit over Semaglutide (Wegovy) for Obesity
Tirzepatide demonstrated superior weight loss outcomes compared with semaglutide in the SURMOUNT-5 trial for patients with obesity.

Crinecerfont Reduces Steroid Use for Pediatric CAH in Phase 3 Analysis
Crinecerfont lowered steroid requirements while maintaining hormone control in children with classic congenital adrenal hyperplasia, regardless of baseline characteristics.

Type 1 Diabetes Diagnosed in Adulthood Heightens Cardiovascular Risk
Adults diagnosed with type 1 diabetes face increased cardiovascular and all-cause mortality risks, regardless of age at diagnosis, according to long-term national data.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for April 28-May 4, 2025:
Obicetrapib Achieves Robust LDL-C Reductions in Phase 3 ASCVD Trials
Obicetrapib significantly reduced LDL-C as monotherapy and in combination with ezetimibe in ASCVD patients inadequately controlled by statins, according to Phase 3 data presented at EAS 2025.

MAR001 Cuts Remnant Cholesterol, Triglycerides by 50% in Phase 2a Trial
MAR001, a novel ANGPTL4-targeting monoclonal antibody, reduced remnant cholesterol and triglycerides by over 50% in high-risk patients, suggesting a promising new cardiovascular intervention strategy.

Oral Zervimesine Reduces Geographic Atrophy Lesion Growth in Phase 2 Trial
Zervimesine (CT1812) slowed lesion progression in geographic atrophy secondary to AMD in Phase 2 MAGNIFY trial results, offering a potential oral treatment option.

UBX1325 Matches Aflibercept in Vision Gains for DME at 36 Weeks
UBX1325 demonstrated noninferiority to aflibercept in visual acuity gains in patients with diabetic macular edema over 36 weeks in the Phase 2b ASPIRE study.

Roflumilast Foam 0.3% for Scalp, Body Psoriasis Effective, Safe for Patients
Roflumilast foam 0.3% achieved significant efficacy and rapid symptom control in scalp and body psoriasis, with an FDA decision expected by late May 2025.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for April 21-April 27, 2025:FDA Approves Pz-cel (Zevaskyn) Gene Therapy for RDEB
The FDA has approved pz-cel, the first autologous gene therapy for RDEB, following pivotal Phase 3 data demonstrating efficacy and safety in wound healing.

FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis
Upadacitinib has been approved for giant cell arteritis, supported by Phase 3 data showing its potential to induce sustained remission and reduce corticosteroid reliance.

FDA Approves Nipocalimab Generalized Myasthenia Gravis for Adults, Children
Nipocalimab received FDA approval for gMG in antibody-positive patients aged ≥12, expanding therapeutic options across major serotypes.

Semaglutide Improves Steatohepatitis, Fibrosis in Phase 3 MASH Trial
Phase 3 trial results show semaglutide significantly improves steatohepatitis and fibrosis markers in patients with MASH, without worsening liver histology.

Increased Fasting Blood Glucose Triples Risk of Heart Damage in Adolescents
International data links elevated fasting glucose and insulin resistance in adolescence to markedly increased future risk of heart damage, especially among females.

Introducing Liver Lineup: Updates & Unfiltered Insights — an exciting new podcast delivering timely, candid perspectives on the most pressing topics in the fast-moving world of hepatology. Created by Nancy Reau, MD, and Kimberly Brown, MD, and hosted by HCPLive, this series dives into the cutting edge of liver disease research, clinical care, and real-world practice.

Intended for hepatologists, gastroenterologists, and other clinicians managing liver disease, Liver Lineup will unpack the latest research, debate emerging controversies, and spotlight developments that could shape — or sharpen — day-to-day practice, all with unfiltered perspective and clarity.

Brown is division chief of gastroenterology and hepatology and the Associate Medical Director of the Henry Ford Hospital Transplant Institute at Henry Ford Hospital. She is also a Professor of Medicine at Wayne State University

Reau is a professor of internal medicine, the Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and the section chief of Hepatology at Rush University Medical Center.

In the inaugural episode, Brown and Reau introduce the mission behind Liver Lineup and share why they created the podcast. Driven by a shared commitment to education, clinical excellence, and elevating the conversation around liver disease, the hosts describe their hope to offer practicing clinicians a clear, concise, and engaging way to keep up with the latest news and innovations in hepatology. They aim to highlight data that’s not only new, but meaningful — spotlighting developments that can improve patient care today and shape best practices tomorrow.

Together, the Brown and Reau set the stage for what’s to come: expert commentary on major liver meetings including Digestive Disease Week, European Association for the Study of the Liver Congress, The Liver Meeting from the American Association for the Study of Liver Diseases, and the American College of Gastroenterology Annual Meeting; coverage of key topics like MASLD, liver cancer, viral hepatitis, and transplant; and conversations with colleagues across the hepatology spectrum. From debates over practice-changing data to discussions on care pathways and diagnostics, Liver Lineup aims to keep clinicians informed, engaged, and ready to translate insight into impact.

Looking ahead, Brown and Reau preview upcoming episodes covering major hepatology updates from Digestive Disease Week 2025 and European Association for the Study of the Liver Congress 2025 — with more to follow throughout the year.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for March 31-April 6, 2025:Cedars-Sinai Study Finds AI Tool Could Improve Care in Virtual Urgent Care SettingsA Cedars-Sinai study suggests AI tools may enhance guideline adherence and decision-making quality in virtual urgent care, though clinician oversight remains essential.
FDA Accepts Biologics License Application for ONS-5010 for Wet AMDThe FDA has accepted a resubmitted BLA for ONS-5010, a proposed ophthalmic formulation of bevacizumab for wet AMD, advancing it toward potential approval.
Socioeconomic Status Impacts Pediatric Preemptive Kidney Transplant Rates, Study FindsA retrospective study linked lower socioeconomic status to reduced access to preemptive kidney transplants in pediatric patients, underscoring ongoing disparities in care.
FDA Clears Dexcom G7 15 Day CGM SystemThe FDA has cleared the Dexcom G7 CGM system for 15-day use in adults, offering extended wear and continued improvements in diabetes monitoring technology.
Icotrokinra Clears Skin Among 75% of Adolescents with Plaque PsoriasisNew phase 3 data show once-daily icotrokinra improves skin clearance and maintains a favorable safety profile in adolescents with moderate-to-severe plaque psoriasis.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for March 23-30, 2025:
Zetomipzomib Shows Promise for Autoimmune Hepatitis in Phase 2a PORTOLA Trial
Zetomipzomib demonstrated steroid-sparing biochemical remissions in refractory autoimmune hepatitis patients, aligning with AASLD treatment guidelines in the Phase 2a PORTOLA trial.

Solriamfetol Significantly Reduces ADHD Symptoms in Axsome’s Phase 3 Trial
Solriamfetol met its primary endpoint in the Phase 3 FOCUS trial, significantly improving ADHD symptoms, with a higher proportion of patients achieving clinical response compared to placebo.

Sozinibercept for Wet AMD Misses Primary Endpoint in Phase 3 COAST Trial
Sozinibercept combined with aflibercept failed to meet the primary endpoint for visual acuity improvement in wet AMD, showing no added benefit over aflibercept monotherapy.

FDA Approves Gepotidacin (Blujepa) for Uncomplicated UTI
The FDA approved gepotidacin for uncomplicated urinary tract infections based on Phase 3 trials demonstrating non-inferiority to nitrofurantoin in female adults and adolescents.

FDA Issues CRL for Etripamil Nasal Spray (Cardamyst) in PSVT
The FDA issued a Complete Response Letter for etripamil nasal spray, citing manufacturing and control issues while confirming no concerns regarding its clinical safety or efficacy.

Welcome back to New Insight with Veeral Sheth, MD!

Veeral Sheth, MD, is joined by Rich Small, the CEO of Neurotech, to discuss the historic approval of revakinagene taroretcel (ENCELTO) a groundbreaking encapsulated cell therapy for macular telangiectasia type 2 (MacTel). This approval marked the first and only FDA–approved treatment for MacTel, a neurodegenerative disease of the retina that can cause progressive and irreversible vision loss.

Speaking with Sheth, Small recounted the long journey of Neurotech, which began in 2007, emphasizing the perseverance required to bring ENCELTO to market. He detailed his transition from Chief Financial Officer to CEO in 2016 and highlighted his team’s commitment, many of whom have been with the company for over a decade.

The conversation explored the scientific foundation of ENCELTO, which uses genetically modified cells to release neurotrophic factors that protect photoreceptors in the retina. Unlike previous treatments that relied on best corrected visual acuity (BCVA) as a clinical endpoint, ENCELTO’s approval was enabled by advancements in imaging technology that allowed for direct measurement of photoreceptor health. Sheth and Small discussed the ideal patient profile for ENCELTO, noting that early intervention is key to preserving vision in MacTel patients.

With ENCELTO’s approval secured, Small indicated the next step is widespread adoption, introducing ENCELTO.com as a patient service hub designed to streamline diagnosis, treatment, and access to care.

Ophthalmology #Podcast #RareDisease

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

New ACP Guidelines Recommend Adding Triptan to NSAID or Acetaminophen for Migraines
The American College of Physicians now recommends adding a triptan to NSAIDs or acetaminophen for moderate to severe acute migraines and urges clinicians to initiate combination therapy early.

Automated Insulin Delivery Effectively Lowers HbA1c in Type 2 Diabetes
Tandem Diabetes Care’s Control-IQ+ automated insulin delivery system led to greater HbA1c reduction than continuous glucose monitoring alone in adults with insulin-requiring type 2 diabetes.

FDA Approves Guselkumab (Tremfya) For Crohn's Disease
The FDA approved guselkumab for moderately to severely active Crohn’s disease based on phase 3 trial data demonstrating superior efficacy over ustekinumab on endoscopic endpoints.

FDA Approves Oral Iptacopan (Fabhalta) as First C3 Glomerulopathy Therapy
The FDA approved iptacopan as the first therapy for C3 glomerulopathy, with phase 3 data showing significant proteinuria reduction and sustained efficacy at 12 months.

FDA Approves Vutrisiran (AMVUTTRA) for ATTR-CM
The FDA expanded vutrisiran’s approval for cardiomyopathy in transthyretin-mediated amyloidosis, making it the first RNAi therapeutic to reduce cardiovascular mortality and hospitalizations in ATTR-CM.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

**Top 5 healthcare headlines for March 9-16, 2025:

1. CagriSema Yields Nearly 16% Weight Loss in Phase 3 REDEFINE 2 Trial**
In the Phase 3 REDEFINE 2 trial, CagriSema showed weight reduction in adults with obesity or overweight and type 2 diabetes, outperforming placebo.

2. Lorundrostat Significantly Lowers Blood Pressure in Key Hypertension Trials
The Phase 3 Launch-HTN and Phase 2 Advance-HTN trials showed lorundrostat effectively reduced blood pressure in uncontrolled or resistant hypertension with a favorable safety profile.

3. PharmaTher Receives New Early June FDA Goal Date for Ketamine
PharmaTher announced the FDA set a new Priority Review goal date of June 4, 2025, for ketamine to treat anesthesia, pain, mental health, and neurological conditions.

4. FDA Awards Fast Track Designation to ATSN-201 Gene Therapy for XLRSThe FDA granted Fast Track designation to ATSN-201 for X-linked retinoschisis, allowing Atsena Therapeutics to seek Priority Review for their gene therapy.

5. FDA Approves First Interchangeable Biosimilar for Omalizumab
The FDA approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar to Xolair for asthma, CRSwNP, IgE-mediated food allergy, and CSU.

Video version available on HCPLive!

In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Riad Sherif, MD, chief executive officer of Oculis, about the company's groundbreaking advancements in ophthalmic therapeutics.

The discussion delves into Oculis' clinical pipeline, particularly OCS-05, a neuroprotective agent demonstrating promising results in acute optic neuritis. The Phase 2 ACUITY trial showed that OCS-05 preserved retinal ganglion cells (RGCs), reduced axonal loss, and improved low-contrast visual acuity. Importantly, patients receiving OCS-05 experienced significantly fewer multiple sclerosis relapses, suggesting broader neuroprotective potential. Administered intravenously alongside corticosteroids, the therapy could represent a paradigm shift in preserving vision in acute optic neuritis and beyond.

Sheth and Sherif also explore Oculis' lead candidate, OCS-01, a topical treatment for diabetic macular edema (DME) that utilizes Optireach™ technology to penetrate the retina. With two ongoing Phase 3 trials (DIAMOND 1 and 2), OCS-01 has the potential to offer a non-invasive alternative or adjunct to intravitreal injections, expanding treatment options for patients with DME. Additionally, Oculis' OCS-02, a TNF inhibitor for dry eye disease, integrates a biomarker-driven precision medicine approach, ensuring targeted therapy for responders and potentially revolutionizing dry eye treatment.

Looking ahead, Oculis is focused on executing its clinical programs, particularly finalizing patient randomization in the DIAMOND trials, advancing precision medicine for inflammation, and expanding indications for OCS-05 in neuroprotection. Sherif envisions OCS-05 as a potential game-changer, addressing significant unmet needs in ophthalmology and neurology by preserving vision and improving quality of life for patients facing vision-threatening diseases.

Key Episode Timestamps00:00:06 Introduction to New Insight
00:01:13 Riad Sherif's Journey from Physician to CEO
00:05:23 Challenges of Balancing Medical and Business Roles
00:09:44 Oculis' Portfolio and Recent Developments
00:14:40 OCS 05 and Its Clinical Applications
00:20:22 Oculis' Team and Leadership Philosophy
00:24:35 Future Goals and Vision for Oculis

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 healthcare headlines for February 16 - 23, 2025:
1. Sotagliflozin Cuts MACE Risk By 23% in Patients with Type 2 Diabetes, CKD
Dual SGLT1/2 inhibition with sotagliflozin significantly reduced both heart attacks and stroke in a prespecified secondary analysis of the SCORED trial.

2. Nebokitug (CM-101) Gets FDA Runway for PSC Approval
Chemomab completed an end-of-phase 2 meeting with the FDA and has aligned on the design of a phase 3 registration study for nebokitug (CM-101) in PSC.

3. FDA Clears IND Application for Zabalafin Hydrogel Treatment of Atopic Dermatitis
Alpyn’s Investigational New Drug application’s clearance by the FDA for the new Zabalafin Hydrogel for atopic dermatitis follows positive phase 2a clinical findings.

4. Expert Panel Develops Consensus Definition, Clinical Tool for Anaphylaxis Care
A 46-member expert panel created a consensus anaphylaxis definition, overview, and clinical tool to aid clinicians in recognition and management across settings.

5. FDA Announces End to Shortage of Semaglutide Products (Ozempic, Wegovy)
The US supply of semaglutide and semaglutide 2.4 mg now meets or exceeds current and projected demand, ending the long-running shortages of these blockbuster drugs.

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories included the US Food and Drug Administration's (FDA) acceptance of a Biologics License Application (BLA) for a cholesterol-lowering drug, long-term data on a dermatologic treatment for hidradenitis suppurativa, an expanded dosing label for a blinding eye disease treatment, and more!

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of February 09, 2025—let’s jump in!

Interested in oncology news? Check out The OncFive, from our sister publication OncLive.
Top News for Healthcare Providers from the Week of 02/09
1. FDA Accepts Lerodalcibep BLA for LDL-C Reduction in High-Risk Patients
The FDA accepted the BLA for lerodalcibep, targeting reductions in low-density lipoprotein cholesterol (LDL-C) levels in patients with or at high risk for atherosclerotic cardiovascular disease (ASCVD) and primary hyperlipidemia. The agency set a Prescription Drug User Fee Act (PDUFA) action date of December 12, 2025, and announced no plans to hold an advisory committee meeting.

2. Travere Therapeutics Plans FSGS Submission for Sparsentan
Travere Therapeutics announced its intent to submit a supplemental New Drug Application (sNDA) for sparsentan (Filspari) with the FDA for the treatment of focal segmental glomerulosclerosis (FSGS) at the end of Q1. The announcement arrived soon after the completion of a Type C meeting with the FDA, with the sNDA based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies.

3. Bimekizumab Long-Term Hidradenitis Suppurativa Data Support Efficacy, Safety Profile
Bimekizumab (Bimzelx) was associated with sustained disease control for up to 2 years in patients with hidradenitis suppurativa (HS), according to presentation of long-term data from the BE HEARD trials. Presented at the 14th Conference of the European Hidradenitis Suppurativa Foundation (EHSF), bimekizumab reduced the symptoms of HS, achieved a low rate of flares, and improved health-related quality of life.

4. Rosnilimab Demonstrates Historic Responses for Rheumatoid Arthritis
Rosnilimab achieved historic American College of Rheumatology (ACR) and clinical disease activity index (CDAI) low disease activity (LDA) responses in patients with rheumatoid arthritis (RA), according to new Phase 2b findings. A depleter and agonist of PD-1+ T cells, rosnilimab was evaluated in the global 424-patient RENOIR trial for efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with moderate-to-severe RA on background conventional disease-modifying antirheumatic drugs (cDMARDs).

5. FDA Expands Dosing Label for Avacincaptad Pegol for Geographic Atrophy
The FDA approved an expanded label for avacincaptad pegol intravitreal solution (IZERVAY) for geographic atrophy (GA), extending the approved dosing beyond 12 months. Announced by Astellas Pharma, the decision comes after the company resubmitted its supplemental New Drug Application (nDA) in December 2024, based on feedback received from the FDA. The company received a Complete Response Letter (CRL) the month prior.

*See you next week!

Editor's note: this was created with the assistance of AI tools.*

Time Stamps:
00:00 Introduction to GLP-1 Agonists and Ethical Considerations
03:38 Current Landscape and Insurance Coverage
06:04 Fair Priority Model and Ethical Principles
13:37 Application of Principles and Tiered Allocation
34:30 Challenges and Objections to the Framework
38:41 Future Considerations and Broader Applications

Video version available on YouTube.

In this episode of Medical Ethics, Steve Levine, Dom Sisti, and guest Johan Dellgren explore the challenges surrounding the equitable allocation of GLP-1 receptor agonists (GLP-1 RAs). As these medications gain recognition for their effectiveness in treating obesity and type 2 diabetes, the discussion explores the systemic barriers preventing equal access, including high costs, insurance coverage limitations, and broader health disparities.

The panel emphasizes the importance of prioritizing those at highest medical risk while also addressing the root causes of healthcare inequities. Watch to learn more about the ethical considerations and potential solutions in ensuring these medications reach those who need them most.

Video Version Available on YouTube!

In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, explored the approval and impending launch of Qlosi (pilocarpine HCL ophthalmic solution) 0.4%, a groundbreaking pharmacologic option for managing presbyopia, with Elad Kedar, MBA, chief executive officer of Orasis Pharmaceuticals.

A condition that affects nearly all adults as they age, presbyopia is characterized by the gradual loss of near vision due to reduced lens elasticity. Sheth and Kedar highlighted the significance of finding non-invasive treatment options for this pervasive issue, given the limitations of traditional solutions like reading glasses or surgical interventions.

In October 2023, the US Food and Drug Administration (FDA) approved Qlosi, a preservative-free, low-dose eye drop for presbyopia, based on strong efficacy, safety, and tolerability data reported in the pivotal Phase 3 NEAR-1 and NEAR-2 clinical trials. On Day 8, patients treated with Qlosi achieved statistically significant ≥3-line gain in distance-corrected near visual acuity (DCNVA) and no loss of ≥1-line in distance visual acuity.

Sheth and Kedar delved into Qlosi’s innovative mechanism of action, emphasizing how it leverages a unique pharmacologic approach to improve near vision. By modulating pupil dynamics, Qlosi enhances the depth of focus, effectively allowing patients to perform near-vision tasks without additional aids. Together, Sheth and Kedar walked through the drug’s clinical development journey, highlighting his journey through the founding of Orasis and the company’s name in Greek, meaning “good vision or sight.”

The discussion included insights into the populations most likely to benefit from Qlosi and the practical considerations for prescribing. Sheth offered a nuanced take on how this therapy could fit into the broader landscape of presbyopia management, addressing questions about patient education, adherence, and expectations.

Sheth also shared his perspective on the potential impact of Qlosi on clinical practice, noting that its ease of use and non-invasive nature could appeal to both patients and providers. He reflected on how treatments like Qlosi are part of a broader trend toward personalized medicine, focusing on solutions that improve the quality of life for aging populations.

This episode concluded with a thoughtful look at future research directions and the impending launch of Qlosi. Expected soon, Kedar expressed an interest in sharing more details on the product and its position in the presbyopia treatment landscape once the drug comes to market.

Every episode of New Insight is available on HCPLive.com. Watch full episodes on our YouTube channel and listen wherever you get your podcasts. Direct all podcast-related inquiries to show producer Connor Iapoce (ciapoce@mjhlifesciences.com) and keep an eye out for more from New Insight!

Key Episode Timestamps00:05 Introduction to Elad Kedar and Orasis
04:34 Orasis' Journey and Initial Development
06:45 Elad Kedar's Background and Company Growth
08:36 Transition from Product Development to Team Building
11:42 Phase Three Study Results and Efficacy
13:39 Safety, Comfort, and Tolerability
15:00 Genesis of the Company Name Orasis
18:26 Challenges and Strategic Planning
21:57 Market Position and Future Outlook
27:27 Conclusion and Future Plans

In the first episode of Medical Ethics Unpacked, hosts Steve Levine, MD, and Dominic Sisti, PhD, examine the profound ethical and clinical challenges surrounding medically assisted suicide, or medical assistance in dying (MAID), for individuals with severe psychiatric conditions. Dr. Sisti, an associate professor at the University of Pennsylvania, interrogates pivotal questions central to this debate, including whether psychiatric disorders can be deemed terminal and whether individuals with such conditions possess the requisite capacity to make autonomous decisions regarding MAID. Drawing on data from jurisdictions such as Belgium and the Netherlands, he highlights critical concerns, including gender disparities, inconsistent capacity evaluations, and the societal risks of expanding access to psychiatric euthanasia without addressing structural deficiencies, such as inadequate mental health care systems or pervasive social inequities.

Dr. Levine, a psychiatrist, explores the complex and dynamic nature of capacity assessments, emphasizing the episodic and often treatable trajectory of psychiatric conditions such as major depressive disorder and anorexia nervosa. He reflects on the potential for recovery facilitated by novel treatments, such as ketamine or psychedelics, juxtaposed with the limitations and gaps in current psychiatric care. Together, the hosts deliberate on the ethical implications of mandating exhaustive treatment attempts, including experimental options, before permitting MAID, balanced against the imperative to respect patient autonomy.

Through a rigorous and nuanced discussion, Drs. Levine and Sisti advocate for the establishment of robust ethical frameworks, equitable practices, and comprehensive capacity evaluations. Their discourse challenges societal and professional norms, encouraging reflection on autonomy, human suffering, and the intrinsic value of life in the context of this ethically fraught issue.

Relevant studies and documentation mentioned in this episode:
* Doernberg, Samuel N., John R. Peteet, and Scott YH Kim. "Capacity evaluations of psychiatric patients requesting assisted death in the Netherlands." Psychosomatics 57, no. 6 (2016): 556-565. * Kim, Scott YH, Raymond G. De Vries, and John R. Peteet. "Euthanasia and assisted suicide of patients with psychiatric disorders in the Netherlands 2011 to 2014." JAMA psychiatry73, no. 4 (2016): 362-368. * Kious, Brent M., and Margaret Battin. "Physician aid-in-dying and suicide prevention in psychiatry: A moral crisis?." The American Journal of Bioethics 19, no. 10 (2019): 29-39. * Nicolini, Marie E., Scott YH Kim, Madison E. Churchill, and Chris Gastmans. "Should euthanasia and assisted suicide for psychiatric disorders be permitted? A systematic review of reasons." Psychological medicine 50, no. 8 (2020): 1241-1256. * Nicolini, Marie E., Chris Gastmans, and Scott YH Kim. "Psychiatric euthanasia, suicide and the role of gender." The British Journal of Psychiatry 220, no. 1 (2022): 10-13. * Sisti, Dominic, J. John Mann, and Maria A. Oquendo. "Suicidal behaviour is pathological: implications for psychiatric euthanasia." Journal of Medical Ethics (2024).

Relevant disclosures for Sisti include Lykos Therapeutics and Tactogen. Relevant disclosures for include Levine include Compass Pathways.

Chapters
00:00 - Introduction
00:45 - Key Issues in the Debate on Euthanasia and Mental Illness
07:25 - Clinical Perspective on Capacity and Competence
12:45 - Challenges in Evaluating Capacity in Mental Illness
19:32 - Treatment Options and the Role of Social Structures
26:35 - The Parity Between Mental and Physical Illness
31:41 - Requiring Treatment Before Considering Euthanasia
34:44 - The Complexity of Egosyntonic Psychiatric Conditions
37:52 - The Potential for "Terminal Addiction"
43:05 - The Societal Impact and Implications of Psychiatric Euthanasia

Lauren Miller, MPAS, PA-C; Jayme M. Heim, MSN FNP-BC, and Lakshi Aldredge, MSN, ANP-BC, discuss recent advancements in plaque psoriasis treatment, focusing on novel oral systemic therapies like the TYK-2 inhibitor deucravacitinib and its clinical trial data, to inform therapeutic decisions for this systemic disease.

Corneal blindness has a significant public health impact, particularly in low- and middle-income countries where access to eye care is limited. It can contribute to a high burden of disability, affecting individuals' quality of life and economic productivity, while straining healthcare systems with the need for preventive measures, surgical treatments, and rehabilitation services.

In the latest episode of New Insight, host Veeral Sheth, MD is joined by John Sheets, PhD, the president, chief executive officer, and co-founder of Pantheon Vision, a pioneering early research-stage organization working to develop bioengineered solutions to eliminate corneal blindness and restore sight to millions.

As part of its mission, Pantheon is dedicated to reducing reliance on donated corneal tissues to address corneal blindness. Although corneal transplant surgery has long been the gold standard, there remains significant room for improvement in graft acceptance, vision restoration, and long-term outcomes to better combat corneal blindness.

Highlights
0:06 Introduction
2:20 Sheet's Background
6:30 Experience with FDA
10:58 Mission of Pantheon Vision
17:10 Corneal Transplant Alternatives
22:54 Overcoming Challenges
28:49 Conclusion

ophthalmology #cornea #podcast

Proton pump inhibitors have long been the mainstay of treatment for gastroesophageal reflux disease (GERD), dating back to omeprazole (Prilosec)’s initial approval in 1989. However, the treatment landscape has undergone its first major changes in the past 30 years with the emergence of vonoprazan (Voquezna).

A novel, first-in-class small molecule potassium-competitive acid blocker (PCAB), vonoprazan now boasts 3 US Food and Drug Administration (FDA) approvals across both erosive and non-erosive GERD. Less than a year after earning approval for the healing and maintenance of healing of all grades of erosive GERD as well as the relief of heartburn associated with erosive GERD, vonoprazan has also been approved for the treatment of heartburn in non-erosive GERD.

Led by a flood of biologic therapies available and progressing within the therapeutic pipeline, the field of dermatology finds itself in the midst of a watershed moment for many dermatologic conditions. To celebrate and recap the advancements occruing in the first half of 2024, the editorial team of HCPLive Dermatology sat down with James Del Rosso, DO, research director of JDR Dermatology Research and president of the American Acne and Rosacea Society, for more perspective on pipeline movement.

Del Rosso, who also serves as an adjunct clinical professor of Dermatology at Touro University, takes a deep dive into several different disease states in dermatology and highlights how the news to emerge in the last 6 months, as well as prior to the close of 2023, has influenced real-world management.

In the latest episode of New Insight with Veeral Sheth, MD, host Veeral Sheth, MD, director of clinical research at University Retina, speaks with Seemi Khan, chief medical officer at Alkeus Pharmaceuticals, on the company’s lead candidate being evaluated in clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Gildeuretinol is a novel molecule designed as a specialized form of deuterated vitamin A to reduce the dimerization of vitamin A without disrupting vision. The therapy has received Breakthrough and Orphan Drug designations from the US Food and Drug Administration (FDA).

Listen to the conversation between experts on Khan’s background in the pharmaceutical industry, including time spent at Abbott, Abbvie, and Quark Pharmaceuticals, her experience bringing treatments to patients with rare diseases, and the impressive data from gildeuretinol in the TEASE clinical trial program for a currently unmet need.

Episode Highlights
0:07 Episode Intro
0:57 Seemi Khan's background
4:38 Mechanism of action of gildeuretinol
7:22 Patient populations
9:00 TEASE clinical trial program
14:37 Gildeuretinol in GA
16:32 Safety data
18:47 Next steps for Alkeus
22:28 Conclusion

Check out more ophthalmology coverage at HCPLive.com!

In the latest episode of New Insight with Veeral Sheth, MD, host Veeral Sheth, MD, director of clinical research at University Retina, speaks with Seemi Khan, chief medical officer at Alkeus Pharmaceuticals, on the company’s lead candidate being evaluated in clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Gildeuretinol is a novel molecule designed as a specialized form of deuterated vitamin A to reduce the dimerization of vitamin A without disrupting vision. The therapy has received Breakthrough and Orphan Drug designations from the US Food and Drug Administration (FDA).

Listen to the conversation between experts on Khan’s background in the pharmaceutical industry, including time spent at Abbott, Abbvie, and Quark Pharmaceuticals, her experience bringing treatments to patients with rare diseases, and the impressive data from gildeuretinol in the TEASE clinical trial program for a currently unmet need.

Episode Highlights
0:07 Episode Intro
0:57 Seemi Khan's background
4:38 Mechanism of action of gildeuretinol
7:22 Patient populations
9:00 TEASE clinical trial program
14:37 Gildeuretinol in GA
16:32 Safety data
18:47 Next steps for Alkeus
22:28 Conclusion

Check out more ophthalmology coverage at HCPLive.com!

Since the mid-20th century ushered in the ‘Information Age’, a desire for innovation has driven the pursuit of technological advancements. Many may immediately consider the transformations personal computers and smartphones have had on modern society, but these advancements have transformed the fields of medicine time and time again.

In the latest episode of New Insight with Veeral Sheth, MD, Michael Freeman, the chief executive officer of Ocutrx, joins Dr. Sheth to discuss the history of Ocutrx, its OcuLez and OR-Bot products, and what he envisions in the next decade at the company.

Episode Highlights
0:06 Introduction
1:22 History of Ocutrx
9:05 A look at the Oculenz
18:27 Introduction of a caretaker app
19:26 A look at the OR-Bot
25:55 Envisioning the next decade at Ocutrx
29:02 Conclusion

Every episode of New Insight is available on HCPLive.com and be sure to subscribe to our channel on Spotify and Apple Podcasts. Please direct any podcast-related inquiries to show producer Connor Iapoce at ciapoce@mjhlifesciences.com.

Episode Highlights:
0:16 Intro

0:28 Overview of presentation

0:38 Acne and post-inflammatory hyperpigmentation

01:35 Approaches to take

03:21 Rosacea, use of dermoscopy and symptomatology assessment

04:59 Necessity of inclusivity in clinical trials, other knowledge gaps

06:05 Images used in education

The American Academy of Dermatology (AAD) Annual Meeting in 2024 featured Dr. Andrew Alexis, a prominent figure in dermatology. Dr. Alexis, currently serving as the vice-chair for diversity in the department of dermatology and a professor of clinical dermatology at Weill Cornell Medical College in New York, presented a talk titled "Controversies in Acne and Rosacea."

In the interview, he shed light on critical aspects of managing acne and rosacea, particularly focusing on patients with skin of color.

Dr. Alexis advocated for inclusivity in clinical trials to improve understanding across diverse patient populations. He stressed the importance of expanding public awareness of rosacea in communities with skin of color and suggested incorporating diverse images into educational materials to better represent the spectrum of affected individuals.

Dr. Alexis's insights underscore the necessity of tailored approaches and increased inclusivity in dermatological research and education to better serve patients with diverse skin tones and backgrounds.

For additional information covered at the 2024 AAD conference, visit us at: https://www.hcplive.com/conference/aad.

In the medical community, a revolving cast of players plays a pivotal role in advancing scientific discovery and enhancing patient outcomes. During the research stage, a collaborative team effort, from the clinical trial sponsors to research sites and patient populations, is essential to ensure smooth progress and sustain momentum toward the finish line.

The latest episode of New Insight with Veeral Sheth, MD features a conversation with Brad Doerschuk, the CEO of InFocus Clinical Research, on the important role of contract research organizations (CROs) in retina and the field of ophthalmology.

In their conversation, Sheth and Doerschuk shed light on the role of CROs in managing clinical trials, dive into the evolution of the retina space in recent decades, and describe the challenges in recruiting for trials of new agents.

Episode Highlights
0:00 Introduction
0:52 What is a CRO?
2:13 Development of InFocus
6:45 Discussing the retina pipeline
11:46 Recruitment challenges, solutions
15:50 Developing new clinical trial sites
18:19 Relationship between investigators, CROs
19:56 Shift in FDA guidance
23:14 New trial endpoints
25:16 Conclusion

Every episode of New Insight is available on HCPLive.com and be sure to subscribe to our channel on Spotify and Apple Podcasts. Please direct any podcast-related inquiries to show producer Connor Iapoce at ciapoce@mjhlifesciences.com.

A special double-episode of New Insight with Veeral Sheth, MD features a well-rounded conversation on all things ophthalmology with returning guest David Eichenbaum, MD, the director of research for Retina Vitreous Associates of Florida, as well as first-time guest Roger Goldberg, MD, a vitreoretinal surgeon at Bay Area Retina Associates.

The trio of retina specialists discuss recent conference news, the anniversary of a landmark agent, and what’s to come in 2024 for the specialty.

Episode Highlights:
0:00 Introduction
1:25 Entering 2024
7:34 The importance of treatment efficacy
12:09 Re-engaging GA treatment
15:05 Comparing aflibercept 8 mg and faricimab
23:00 Real-world data sets
26:30 What’s to come in 2024
27:45 Intravitreal gene therapies
31:00 Port delivery system
36:00 Wrapping-up

Every episode of New Insight is available on HCPLive.com and be sure to subscribe to our channel on Spotify and Apple Podcasts. Please direct any podcast-related inquiries to show producer Connor Iapoce at ciapoce@mjhlifesciences.com.

In every episode of New Insight, Veeral Sheth, MD, Director of Clinical Trials at University Retina in Chicago, takes an in-depth look at the biggest news in ophthalmology and the behind the scenes work involved in eye care, with a rotation of guest experts involved in ophthalmic research, development, and clinical care.

The latest episode of New Insight features a conversation with Ocuphire Pharma’s CEO on the company’s flagship retinal product and leading a small, but high-powered research team.

Episode Highlights:
0:04 Introduction
1:23 History of Ocuphire Pharma
3:50 Leading a small, high-functioning team
6:41 Magrath’s background and journey
11:02 APX3330 for Diabetic Retinopathy
15:20 2024 Plans for Ocuphire
18:53 Addressing unmet needs
20:20 Outro

Every episode of New Insight is available on HCPLive.com and be sure to subscribe to our channel on Spotify and Apple Podcasts. Please direct any podcast-related inquiries to show producer Connor Iapoce at ciapoce@mjhlifesciences.com.

On the floor at AAO 2023, host Veeral Sheth, MD, and producer Connor Iapoce discuss UBX1325 for patients with diabetic macular edema, based on the 48-week results from the phase 2 BEHOLD study.

Episode Highlights:
0:30 Introduction
0:48 Background into UBX1325 and BEHOLD
2:49 BEHOLD 48-week results
6:05 Next steps
6:56 Conclusion

Please direct any podcast-related inquiries to ciapoce@mjhlifesciences.com.

Episode Highlights

0:12 Intro 1:24 Challenges in autoimmune hepatitis 3:30 Patient demographics 4:25 Diagnostic challenges 6:35 What is overlap syndrome? 8:04 Mysteries behind immune dysregulation 9:05 Promising drugs in investigation 10:51 The BAFF receptor target 11:41 Infliximab & rituximab 12:38 An autoimmune hepatitis wishlist
15:29 Outro

Autoimmune hepatitis (AIH), a rare liver disease characterized by an unclear driver of inflammation, is historically challenged by limited clinical understanding, a slow development of treatment options in investigation, and a nonetheless concerning prognosis for affected adults and children.

While some prospects are in development to aid specialists in adequately identifying risk factors for, diagnosing and treating AIH, education and communication on those developments is vital.

In an interview with HCPLive during the American College of Gastroenterology (ACG 2023) Annual Scientific Meeting in Vancouver, BC this week, Gina Choi, MD, associator clinical professor of medicine and surgery at UCLA Health, discussed the ins and outs of modern autoimmune liver disease research and development.

Including the treatment pipeline and current standards for diagnostics, Choi additionally discussed the sociodemographic and pathophysiological traits of AIH burden—as well as the lesser-known overlap syndrome.

For more hepatology and gastroenterology coverage from ACG 2023, visit us at https://www.hcplive.com/conference/acg.

Host Veeral Sheth, MD is joined by Megan Baldwin, PhD, CEO and Managing Director of Opthea Limited, to discuss OPT-302 or sozinibercept, the company's novel anti-VEGF-C / VEGF-D treatment for wet AMD and other retinal diseases.

Please direct any podcast-related inquiries to ciapoce@mjhlifesciences.com.

Warren Jones, PhD, scientific founder of EarliTec Diagnostics and autism expert, discusses his team's development of an eye-tracking device recently authorized by the FDA and proven in clinical trials to predict autism consistent with expert diagnoses.

After a historically low-transmission summer, new cases, hospitalizations and deaths due to COVID-19 have increased by approximately 18% in the US over the last week, according to CDC data.

In a new DocTalk interview, Donald J. Alcendor, PhD, associate professor, department of pathology microbiology and immunology, division of infectious diseases, Vanderbilt University Medical Center, and HCPLive Editorial Advisory Board member, discussed the factors influencing the current iteration of COVID-19 in the US. Put briefly: “The virus is changing, and immunity is waning.”

Want more COVID-19 and health care news updates? Visit us at HCPLive.com.

Episode highlights:

0:16 Intro

1:36 The current climb in COVID-19: What’s happening?

3:58 Are the variants becoming harder to dodge?

7:01 How the end of the US public health emergency impacted prevention

11:07 Realistic vaccine expectations

13:13 Advancing COVID-19 antivirals

17:32 The future for mRNA vaccines infectious disease

21:27 Public health implications

22:58 A quiet COVID-19 summer: What went well?

25:06 Projecting future waves

28:26 Advice for clinicians in preparing patients

In this episode, host Veeral Sheth, MD, and producer Connor Iapoce discuss 5 important presentations from ASRS 2023. The discussion centers around new data on geographic atrophy therapies, novel agents for DME, and the feasibility of home OCT.

Please direct any podcast-related inquiries to ciapoce@mjhlifesciences.com.

The newest episode of New Insight with Veeral Sheth, MD features a conversation with David Eichenbaum, MD, the director of research for Retina Vitreous Associates of Florida. A seasoned clinical trial investigator and a friendly face at major medical meetings, Eichenbaum provides insights into his goals behind mentorship and inspiring others, sharing anecdotes about his own journey. On the heels of an already busy year, the experts discuss evolutions in the field and the pipeline, as the retina landscape changes each calendar month. In this vein, the two specialists discuss their ever-changing roles from investigators to mentors to stewards for the next generation of retina specialists.

Please direct any podcast-related inquiries to show producer Connor Iapoce at ciapoce@mjhlifesciences.com.

In the latest episode of New Insight, Veeral Sheth, MD sat down with Cedric Francois, MD, PhD, co-founder and chief executive officer/president of Apellis Pharmaceuticals. The two experts discussed the company's landmark therapy, pegcetacoplan (SYFOVRE™), for geographic atrophy and the decades-long journey toward FDA approval. Sheth also asked about Francois' evolving role in the company and the interplay between being a scientist, clinician, and corporate executive. The experts also touched on how the GA treatment landscape might evolve over the next few years and what will shape the future of retina.

Please direct any podcast-related inquiries to ciapoce@mjhlifesciences.com.

In this episode, Veeral Sheth, MD, sits down with Jay Duker, MD, the president and chief operating officer of Eyepoint Pharmaceuticals, for a discussion on his storied career in ophthalmology, the importance of fostering a relationship between clinicians and industry, and the current biotech Dr. Duker and team are working on at Eyepoint.

Please direct any podcast-related inquiries to ciapoce@mjhlifesciences.com.

In this episode, Charles Wykoff, MD, PhD joins Dr. Sheth to provide insight into the recent landmark approval of pegcetacoplan injection (SYFOVRE™) for geographic atrophy, how clinical practice has changed as a result, and both the early struggles with and optimism for an ever-changing treatment landscape.

Please direct any podcast-related inquiries to ciapoce@mjhlifesciences.com.

As part of our ARVO 2023 coverage, Dr. Sheth sat down with Pravin Dugel, MD, President of Iveric Bio. Together, the experts discussed the lead molecule for the company, avacincaptad pegol for geographic atrophy, and touched on the data being presented at the conference, as well as a look back at Dugel's career and his transition into industry.

The inaugural episode of New Insight with Veeral Sheth, MD, our premier ophthalmology-focused podcast, features a conversation with Arshad Khanai, MD, the Director of Clinical Research at Sierra Eye Associates in Reno, Nevada.

Together, our experts discuss their background and education in retina, and how they started working on clinical trials. They go on to describe the work that has led to recent landmark drug approvals in ophthalmology, including faricimab and pegcetacoplan, and the impact of these treatments on patients.

Friends and colleagues for nearly 20 years, Sheth and Khanani talk a bit about their history, what mentorship means in medicine and their role as mentors to fellows and younger colleagues within the space.

Lastly, the two KOLs discuss what they are looking forward to in the year, with particular mention of upcoming meetings and developments that may define the year 2023.

We hope you enjoy our first episode! Keep an eye out for more from New Insight.

The latest offering from HCPLive Podcasts is New InSight with Veeral Sheth, MD, an in-depth series examining the biggest news in ophthalmology. The podcast will feature conversations on research news and new therapies, landmark findings from major medical meetings, and the day-to-day life of an ophthalmologist in the 21st century. A range of guests will join Dr. Sheth to share perspective and provide new insight into an ever-changing and ever-growing field. Stay tuned for our first episodes set to be released in April. But, for now, enjoy this first look at New InSight!

Lawrence Eichenfield, MD, reviews major drug approvals and advancement of screening and prevention strategies for the youngest patients with atopic dermatitis.

As 2022 concludes, a dermatologist reflects on the first drug approved for vitiligo.

Dr. Lally of New England Retina Consultants joins to discuss avacincaptad pegol, a promising injection treatment for GA, and its supporting data from the GATHER trial program.

Will the complement C5 inhibitor drug receive FDA approval in 2023? Lally discusses this and more on the latest DocTalk.

One of the most notable topics discussed at the 2022 American Academy of Ophthalmology Meeting in Chicago was new advancements in geographic atrophy (GA) treatment.

A form of advanced age-related macular degeneration (AMD), there are no currently available treatments for the debilitating disease.

In this episode of DocTalk, we spoke with Arshad Khanani, MD, Director of Clinical Research, Sierra Eye Associates, on the findings from the GATHER2 trial on avacincaptad pegol for the treatment of GA.

Throughout our conversation, Khanani laid out the first-time efficacy results of the phase 3 trial and its patient population, the overall safety of the agent, and what it might mean to alleviate the biggest unmet need in retina today.

We hope you enjoy. If you are interested in more content from AAO 2022 or our ophthalmology coverage, visit us at HCPLive.

Martha Gulati, MD, Director of Preventive Cardiology, Associate Director of the Barbara Streisand Women’s Heart Center, Associate Director of Preventive and Cardiac Rehabilitation at Cedars-Sinai Medical Center, joins Heart Team to discuss current challenges in women’s cardiovascular disease research and clinical advancement.

Gulati also provides guidance on improving female trial enrollment strategies and patient recruitment, and her thoughts on clinician perception of cardiovascular symptoms in men versus women.

Heart Team is a monthly multimedia series hosted by Jorge Plutzky, MD, Director of Preventive Cardiology at Harvard Medical School, and Michael Farkouh, MD, Director of the Peter Munk Clinical Trials Unit and Vice Chair of Medicine at the University of Toronto.

Watch the video of this interview, with more insights from Dr. Plutzky and Dr. Farkouh, at HCPLive.com.

In the first episode from this new cardiovascular medicine series, hosts Dr. Jorge Plutzky and Dr. Michael Farkouh speak with University of Maryland's Dr. Matthew Weir about the growing involvement of renal care in modern heart disease patients.

This past week, the American Society of Retina Specialists (ASRS) held its 40th Annual Meeting in New York City to discuss landmark data and the newest advancements in retina care.

The HCPLive team was on-site at the Javits Center in Manhattan conducting interviews with expert retina specialists on topics including drugs for neovascular age-related macular degeneration and geographic atrophy, as well as landmark trials including the phase 3 TENAYA and LUCERNE.

On this episode of DocTalk, we share the biggest highlights and the biggest news from our conversations at the meeting with 5 expert clinicians.

On Monday, the US Food and Drug Administration (FDA) approved ruxolitinib cream 1.5% for the treatment of nonsegmental vitiligo in adults and pediatric patients 12 years and older, making it both the first FDA-approved therapy for repigmentation and the only topical formulation of a JAK inhibitor approved in the United States.

The groundbreaking approval was supported by phase 3 data from the TRue-V clinical trial program, which found that roughly 3 in 10 patients who were treated with ruxolitinib cream achieved ≥90% improvement on facial vitiligo regimentation after 52 weeks of treatment.

David Rosmarin, MD, Vice Chair for Research and Education at Tufts Medical Center and leading investigator of the True-V program joined us on DocTalk to share his enthusiasm for the approval and speak on how ruxolitinib cream could offer hope to patients who can’t access or properly respond to standard treatments for vitiligo.

“One of the challenges with treating vitiligo is that our big treatment is phototherapy, and that's really inconvenient and inaccessible for many; to have to come into an office for light treatments 2 to 3 times a week is really inconvenient, and sometimes prohibitive,” Rosmarin said “It can also be very costly if there are co-pays each time a patient needs phototherapy. So, having an option where patients can use, at home, a cream twice a day, and the convenience of that, is really important. The best ability is availability. If a patient can't access a treatment, it's no good.”

Last week, the US Food and Drug Administration (FDA) approved the co-treatment of pegloticase (Krystexxa) injection plus methotrexate (MTX) for uncontrolled gout, a decision bolstered by data from phase 4 of the MIRROR study.

In that study, 71% of patients who were treated with this combination therapy achieved a complete response over the course of 6 months. Comparatively, only 38.5% of patients who received pelgoticase plus placebo achieved a complete response.

In a then-recent statement, John Botson, MD, RPh, Rhuematology Director at Orthopedic Physicians Alaska stated that the medical community had been “actively engaged” in findings therapeutic options for uncontrolled gout via pelgoticase therapy.

As one of the primary investigators of the MIRROR study, Botson was keenly aware of the implications of this new FDA decision, noting that this new co-treatment option could allow clinicians to “change outcomes for many uncontrolled gout patients, most of whom have no other treatment option."

For this episode of DocTalk, Botson sat down with Associate Editor Giuliana Grossi and spoke of how combination therapy for gout has led to less infusion reactions and increased efficacy, as well as how clinicians have safely incorporated low dose methotrexate, and what he feels will be the future of gout research.

“In the previous studies, about a quarter of the patients would have infusion reactions and lead to some of the side effects that came from getting the medication, and in this case we had 30.6% of the patients on the placebo who didn't take the methotrexate, and only 4.2% of the ones that got the combination,” Botson said. “So basically, there was a 90% or so improvement in safety and a doubling of the efficacy by using the combination. Those were huge, huge takeaways.”

Despite a bevy of biologics available for people struggling with Crohn’s disease and ulcerative colitis (UC), not all patients are able to respond to or tolerate a vast majority of approved therapies.

Fortunately, new data presented at Digestive Disease Week (DDW) 2022 suggests that ustekinumab (STELARA) could function as an alternative option to bio-failure and bio-naïve patients living with these inflammatory bowel diseases (IBD).

Pooled data from four long-term phase 2 and 3 studies of bio-naïve IBD patients found that event rate per 100 patient-years for adverse events (AE), serious AEs, infection, malignancies, and more were similar and/or numerically lower for patients who received ustekinumab compared to those on placebo.

Similar event rates were observed in five phase 2/3 IBD studies of bio-failure patients over a 5-year period.

Additionally, new phase 2 data showed that participants treated with guselkumab who had inadequate responses to conventional therapies achieved high levels of clinical-biomarker response, endoscopic response, and clinical remission compared to those on placebo.

For this episode of DocTalk, Assistant Managing Editor Kenny Walter spoke with Remo Panaccione, MD, Director of the IBD Clinic and Director of Gastroenterology Research at the University of Calgary, of the implications of the new ustekinumab and guselkumab data on long-term IBD care.

If you’ve been keeping an eye on recent developments in ophthalmic care, then you’ll know that several new therapeutic agents that had been approved by the US Food and Drug Administration (FDA) in recent months, including ranibizumab delivered via Port Delivery System (PDS) and faricimab, the latter of which became the first-of-its-kind intravitreal bispecific biologic therapy for both age-related macular degeneration (AMD) and diabetic macular edema.

But the recent advancements in ophthalmology don’t stop there. As Veeral Sheth, MD, Director of Clinical Trials at University Retina would explain, there is so much going on in the world of eye care that it’s been “hard to keep track of all the work”.

In this episode of DocTalk, Dr. Sheth sits down with Associate Editor Connor Iapoce to discuss the potential of gene therapy, developments in the wet- and dry-AMD spaces, new approaches in the management of pigment dispersion syndrome, and the benefits of home-based optical coherence tomography.

Earlier this month, dupilumab became the first and only biologic medicine approved by the US Food and Drug Administration for the treatment of atopic dermatitis in patients of all ages, from infancy through adulthood.

The approval of dupilumab as an add-on maintenance therapy for children 6 months to 5 years with moderate to severe atopic dermatitis was described as “a tremendous advancement” by Mercades E. Gonzalez, MD, FAAD, pediatric dermatologist at Pediatric Dermatology of Miami.

Gonzalez joined the DocTalk program to speak on the unmet need for therapies such as dupilumab for young children affected by AD, and the various psychological and mental burdens of the skin disease.

On June 13, the US Food and Drug Administration (FDA) approved oral baricitinib (Olumiant) tablets for the treatment of severe alopecia areata in adults, which marked the first approval of a systemic treatment for the disorder.

The approval has excited patients and providers alike who struggled for decades to treat severe cases of this autoimmune disorder.

For this episode of DocTalk, several key opinion leaders in the dermatology field sound off on the implications of this decision, as well as the versatility of Janus kinase (JAK) inhibitors, and how this approval will aid providers in redefining alopecia areata as an autoimmune disorder rather than simply a cosmetic condition, which will help more patients receive proper care.

Joining us on the podcast and in written form are the following dermatologists:

Brett King, MD, PhD, Yale School of Medicine, New Haven
Lisa Arkin, MD, member of the Society for Pediatric Dermatology, University of Wisconsin School of Medicine & Public Health / American Family Children's Hospital.
Karan Lal, DO, MS, FAAD, Schweiger Dermatology Group and member of The Society for Pediatric Dermatology
Brittany Craiglow, MD, Yale School of Medicine, New Haven

On June 13, the US Food and Drug Administration (FDA) approved oral baricitinib (Olumiant) tablets for the treatment of severe alopecia areata in adults, which marked the first approval of a systemic treatment for the disorder.

The approval has excited patients and providers alike who struggled for decades to treat severe cases of this autoimmune disorder.

For this episode of DocTalk, several key opinion leaders in the dermatology field sound off on the implications of this decision, as well as the versatility of Janus kinase (JAK) inhibitors, and how this approval will aid providers in redefining alopecia areata as an autoimmune disorder rather than simply a cosmetic condition, which will help more patients receive proper care.

Joining us on the podcast, and in written form, are the following dermatologists:

· Brett King, MD, PhD, Yale School of Medicine, New Haven · Lisa Arkin, MD, member of the Society for Pediatric Dermatology, University of Wisconsin School of Medicine & Public Health / American Family Children's Hospital. · Karan Lal, DO, MS, FAAD, Schweiger Dermatology Group and member of The Society for Pediatric Dermatology · Brittany Craiglow, MD, Yale School of Medicine, New Haven

On June 13, the US Food and Drug Administration (FDA) approved oral baricitinib (Olumiant) tablets for the treatment of severe alopecia areata in adults, which marked the first approval of a systemic treatment for the disorder.

The approval has excited patients and providers alike who struggled for decades to treat severe cases of this autoimmune disorder.

For this episode of DocTalk, several key opinion leaders in the dermatology field sound off on the implications of this decision, as well as the versatility of Janus kinase (JAK) inhibitors, and how this approval will aid providers in redefining alopecia areata as an autoimmune disorder rather than simply a cosmetic condition, which will help more patients receive proper care.

Joining us on the podcast, and in written form, are the following dermatologists:

· Brett King, MD, PhD, Yale School of Medicine, New Haven · Lisa Arkin, MD, member of the Society for Pediatric Dermatology, University of Wisconsin School of Medicine & Public Health / American Family Children's Hospital. · Karan Lal, DO, MS, FAAD, Schweiger Dermatology Group and member of The Society for Pediatric Dermatology · Brittany Craiglow, MD, Yale School of Medicine, New Haven

After presenting at the SLEEP 2022 annual meeting, Dr. Aric Prather explains the findings of his previous research demonstrated lack of sleep (6 hours or less) was associated with a 4 times higher risk of becoming sick after exposure to rhinovirus in an interview with HCPLive. Currently, Prather and his team at UCSF are working with a large naive population for a study that began in March 2021. They've been able to evaluate various aspects of health by following individuals through the COVID-19 vaccination and booster process. According to Prather, the aim is to identify psychological, behavioral, sleep, and biological predictors of who mounts and maintains protection.

In recognition of National Scleroderma Awareness Month, HCPLive spoke with several prominent dermatologists today who addressed some of the concerns and advancements related to the rare, multi-system disease.

Scleroderma is often referred to as “morphia” by dermatologists, and the condition typically presents with the tightening and hardening of the skin. Depending on the region of the body, it can result in everything from swollen joints to lesions on the face, arms, and midsection.

For this episode of DocTalk, Karan Lal, DO, MS, FAAD, Schweiger Dermatology Group and member of The Society for Pediatric Dermatology , returned to the program to speak on the different variations of morphia in pediatric patients, and the communal approach that is required to treat the disease among dermatologists and other branches of medicine.

Last week, the US Food and Drug Administration approved tapinarof cream, 1% (VTAMA) for the treatment of plaque psoriasis of all severities in adult patients, ushering in the first and only FDA-approved steroid-free topical medication in its class.

Remarkably, it had been 25 years since a novel chemical entity had been introduced into psoriasis care from a brand-new mechanism of action, and from the data gathered from the phase 3 PSOARING 1 and 2 trials as well as the long term extension (LTE) study, it couldn’t have come at a better time.

Pivotal phase 3 data showed treatment with tapinarof cream led to statistically significant improvements in Physician Global Assessment (PGA) score of “clear” or “almost clear” with a minimum 2-grade improvement compared with vehicle treatment from baseline to week 12.

Better yet, the median duration of clear or almost clear skin was approximately 4 months after cessation of treatment with tapinarof cream, which was detailed in the phase 3 LTE study for patients who achieved clear skin (PGA 0) during PSOARING 1 or 2.

“I think the patients that participated and had exposure to the product for up to a year, were indicating that to us that (tapinarof cream) was easy to use, it was extremely well tolerated, it had remarkable impact on their disease, and the fact that they can discontinue therapy for an extended period of time is absolutely incredible,” said Philip Brown, MD, JD, Chief Medical Officer at Dermavant Sciences.

For this episode of DocTalk, Brown and Chief Executive Officer Todd Zavodnick joined the program to speak to the implications of the FDA decision, and how tapinarof cream is set to revolutionize psoriasis management.

In recent years, the acknowledgement of cardiac involvement in patients with sarcoidosis has become increasingly important. Thanks to advanced screening techniques, new research has suggested that approximately 2-5% of patients with sarcoidosis also struggle with cardiac sarcoidosis.

However, the practice of adding echocardiography and ambulatory ECG to standard screening with the intention of identifying cardiac sarcoidosis has been deemed controversial by some researchers.

Additionally, previous analyses of various screening approaches have been limited by small patient numbers, selection bias, and inconsistent use of echocardiographic parameters such as global longitudinal strain.

“Advanced screening techniques suggests that around a quarter of people with sarcoidosis could have evidence of cardiac sarcoidosis, and so you can see right away that there's a discrepancy between what you can find with an advanced imaging technique,” said Dan Culver, DO, Chair of the Department of Pulmonary Medicine at the Cleveland Clinic. “This raises the question of how much should you look, when do you look and in whom should you look to try to find cardiac sarcoidosis? And this gets us to the original question of how you screen for cardiac sarcoidosis.”

In this episode of DocTalk, Culver spoke on how patients develop cardiac sarcoidosis and why periodic screening could prove beneficial for patients with sarcoidosis.

He also touched on preliminary data of a recent interim analysis regarding the addition of baseline echocardiography and ambulatory ECG in routine screening in patients without obvious cardiac sarcoidosis.

Beyond vaccination, what are some methods for treating COVID-19 in both inpatient and outpatient settings? In the 2 years since the beginning of the pandemic, the strategies for protecting people from this deadly virus have certainly evolved, yet questions remain regarding COVID-19 therapeutics and their availability in certain communities and during times of scarcity.

For this episode of DocTalk, Tara Vijayan, MD, MPH, who is a member of the division of infectious diseases at the David Geffen School of Medicine, offered insights into the mechanisms of several COVID-19 treatments, as well as the primary outcomes of these treatments in clinical trials and how they influence prioritization.

This conversation was based off her session, “Navigating Novel COVID-19 Therapeutics in Times of Scarcity and Beyond,” which was presented at Pri-Med West 2022 in Anaheim, California.

Though she is confident with certain aspects of COVID-19 care, she is also focused on improving upon treatment from “an equity standpoint, an ethical standpoint, and an evidence standpoint”.

Today's episode features Selena S. Li, MD, a Massachusetts General Hospital surgery resident, who recently traveled overseas with a volunteer medical group to provide treatments and care to refugees escaping the Russian invasion.

For more clinical news and expert interviews, visit us at HCPLive.com.

To learn more about donating to or volunteering with Medical Volunteers International, click here.

When it comes to allergies, the number of affected individuals in the United States alone is staggering. Approximately 20 million adults and 6 million children in the US are affected by seasonal allergies, and roughly 32 million Americans struggle with a myriad of food allergies.

Seasonal allergies have been front-of-mind for many Americans, especially with the Spring season in full effect.

The struggles people with seasonal allergies face have no doubt worsened with the introduction of longer and more severe pollen seasons, as well concerning levels of air pollution recorded across the country that were detailed in the latest State of the Air Report by the American Lung Association.

In this wide-ranging interview for DocTalk, Christine Rauscher, MD, member of the Allegheny Health Network and Assistant Professor of Medicine at Drexel University, offered an overview of some of the most common allergies in the US as well as what could be done to prevent severe allergic reactions among adult and pediatric populations.

The newly approved ophthalmic drug faricimab (Vabysmo) has already made waves by being the first of its drug class to be approved for both diabetic macular edema (DME) and neovascular age-related degeneration (nAMD).

A new phase 4 clinical trial from Genentech seeks to expand on the efficacy of the drug in patients with DME from underrepresented populations.

The efficacy and safety of faricimab will be assessed in patients from African American, Hispanic, Latin American, and Indigenous communities throughout the Elevatum trial, which Matthew Cunningham, MD, of the Florida Retina Institute, believes to be the first industry-sponsored assessment regarding representation in DME trials.

For this episode of DocTalk, Cunningham sits down with managing editor Kevin Kunzmann to speak to the issue of representation in DME and other ophthalmology trials, and how DME disproportionately affects underrepresented populations.

Furthermore, Cunningham details the burdens that patients from underrepresented communities face with trial inclusion standards.

When addressing psoriatic disease, it is important to consider how it uniquely affects people with skin of color. People from different racial and ethnic groups often struggle with psoriatic disease due to delays in diagnosis, misdiagnosis, and limited access to diagnostic testing and treatment.

Furthermore, the lack of access to care and treatment has resulted in biologic use being 69% lower in patients with skin of color compared to white patients.

All of these factors stem from a lack of understanding from providers as to how conditions such as psoriasis and psoriatic arthritis affect Black, Hispanic, Asian, and Indigenous communities.

Recently, Janssen Pharmaceuticals announced Determi-Nation, a program created to increase the number of dermatology residents from underrepresented minority groups by over 50% by 2027.

Lynn McKinley-Grant, MD, FAAD, Associate Professor of Dermatology at Howard University College of Medicine and former President of the Skin of Color Society and Determi-Nation member will be offering her indispensable knowledge on psoriatic disease in skin of color to bolster this multi-year commitment.

But her passion for accurate clinical assessments of psoriatic disease in people of color is very much rooted in the present and what can be improved upon now to ensure a more inclusive future for patients with skin of color and psoriasis.

In this episode of DocTalk, McKinley-Grant speaks on psoriatic disease presents itself in skin of color, improving upon diversity in clinical trials, how scientific literature on psoriatic disease continues to evolve, the lack of exposure to skin of color some providers may have based on their location, and much more.

Last week, a new investigation confirmed a higher prevalence of non-alcoholic fatty liver disease (NAFLD) in pediatric patients than previously thought.

The data was part of the ongoing observational study called TARGET-NASH, which included participants with NAFLD and/or alcoholic steatohepatitis (NASH).

The study, which included 660 pediatric patients, cited an increase in liver disease following evaluation of alanine aminotransferase.

Notably, pediatric patients with greater than 250 U/L ATL had an eight-fold greater risk of developing cirrhosis.

For this episode of DocTalk, Miriam Vos, MD, MSPH, Department of Pediatrics, School of Medicine, Emory University, sat down with assistant managing editor Kenny Walter to discuss the data from TARGET-NASH as well as the implications of NAFLD in pediatric patients.

Today, the American Lung Association released the 23rd annual “State of the Air” report, which detailed the nationwide exposure to ozone and particle pollution in the United States in 2022.

The new report revealed that approximately 9 million more people were affected by particle pollution since last year’s report, with more reported days with “very unhealthy” and “hazardous” air quality than ever published in the 2-decade history of the “State of the Air”.

The “State of the Air” report functions as a “report card” of sorts, one that tracks and grades exposure to levels of short-term spikes in particle pollution across the country.

Additionally, the report is defined by 2 grades for particle pollution including “short-term” and “year-round”.

Regarding short-term pollution, the 2022 report found that roughly 63.2 million people lived in counties with an “F” grade for unhealthy spikes in particle pollution, with 4 of the top 4 most polluted cities located in California.

Additionally, more than 20.3 million people were reported to live in 1 of 21 counties where year-round particle pollution levels were worse than the national air quality limit, with all of the top 5 most polluted cities being located in California.

The report also noted that 122.3 million people reside in counties with failing grades for ozone pollution. Despite being 860,000 fewer people than last year’s report, the numbers remain alarming.

Once again, the “State of the Air” report detailed the staggering affect of climate change on air quality in the US.

For this episode of DocTalk, Managing Editor Kevin Kunzmann spoke with Stephanie Lovinsky-Desir, MD, MS, Volunteer Medical Spokesperson for the American Lung Association, who further elucidated the data found in the report.

As a pediatric pulmonologist, Lovinsky-Desir details the notable burden that air pollution has on children. She also speaks to the associations between air quality and cardiovascular disease, the influence of Clean Air Act on better air quality, informing patients on how to avoid certain pollutants, and what can be done to reduce carbon footprints on both personal and communal levels.

“Ultimately, I think the goal is for clean, healthy air, and I think we all as Americans deserve to breathe clean, healthy air,” Lovinsky-Desir said. “So advocating for that on multiple levels, and making sure that we are partnering with the people who are most likely contributing to the emissions, I think is going to be the key. It's a multi-pronged approach. It's not just one specific group that is responsible for making this change.”

An estimated 2 million patients in the United States have vitiligo, which is a dermatologic condition defined by depigmentation of the skin.

Though there is currently no cure, recent medical advancements have helped patients and providers alike gain a broader perspective on the skin condition. Likewise, prominent cultural figures with vitiligo have also contributed addressing the stigma surrounding the disease.

Despite this, vitiligo is still considered by many to be solely a cosmetic condition, though it is very much a medical condition as well.

Sarah Asch, MD, FAAP, FAAD, Society of Pediatric Dermatology , Teledermatology Committee Chair, spoke of how the public perception of vitiligo has evolved in recent years, as well as how vitiligo affects adults and pediatric patients differently and the myriad of promising new therapies that are currently being explored.

Last week, the Alliance for Sleep committee announced new data from the largest sleep-based survey in the US, which found that 70% of people with trouble sleeping due to insomnia were “desperate to find a solution”.

Insomnia affects approximately 25 million adults in the US, and is partially responsible for the roughly $7 billion spent annually on products or sleep aids such as blackout curtains, eye masks, and white noise machines.

Findings from Wake Up America: The Night & Day Impact of Insomnia survey put in to sharp focus the complications of insomnia, which includ a notable lack of discussions being had among patients and providers regarding sleep health.

According to the survey, only 66% of primary care physicians reported frequently asking about sleep during routine visits, and only 27% of patients with trouble sleeping reported that their doctors asked about their sleep during every visit.

Co-chair of The Alliance for Sleep committee Dr. Ruth Benca spoke of how the survey results could provide Americans with wake up call regarding insomnia prevalence and improve upon the conversations between patients and healthcare providers.

As diabetes care continues to evolve, especially in regard to insulin therapies, so too must the conversations being had between patients and doctors.

Fortunately, a recent webinar titled “Institutional Perspectives in Diabetes: New Advances in Insulin Therapy for the Management of Type 2 Diabetes” hosted a myriad of thoughtful discussions regarding the importance of insulin therapies for diabetes care.

As a certified diabetes care and education specialist and a dietitian, Cheryl Marco, RDN, LDN, CDCES at the Division of Endocrinology at Thomas Jefferson University, offered unique and valued insights into how patients with diabetes could implement insulin therapy and healthy dietary practices into their medical regimen.

In an interview with associate editor Giuliana Gross, Dr. Marco spoke of how her presentation, “Patient Communication and Education”, addressed psychological insulin resistance, hypoglycemia management, dietary changes that patients could make to establish a healthier life with diabetes, and continuous glucose sensors.

April is Rosacea Awareness Month!

While the cause of rosacea is still unknown, what is known is that it is estimated to affect up to 16 million people in the United States alone.

Additionally, a recent survey by the National Rosacea Society indicated that 47% of affect patients were unaware of the disorder prior to their diagnosis, and 95% stated that they knew very little about the signs and symptoms of rosacea.

This Friday, HCPLive will be hosting a variety of discussions and new investigations regarding rosacea in an effort to raise awareness of the condition.

For this episode of DocTalk, Karan Lal, DO, MS, FAAD, of the Schweiger Dermatology Group provides information on how doctors diagnose rosace, variations of rosacea, what treatments are currently available, and current trends in research regarding the condition.

Coming live from the American Academy of Dermatology (AAD) 2022 Meeting in Boston, managing editor Kevin Kunzmann sits down with investigators from University of Perelman School of Medicine to discuss new data showing disparities in psoriasis diagnoses by race, and how dermatologists can become more confident in identifying new cases.

Representation of different racial and ethnic groups in clinical trials has been an ongoing concern across all clinical fields, and pediatrics is no exception.

A recent study from Emory University School of Medicine found that the number of pediatric clinical trials that reported participant race and ethnicity had increased from 2011 to 2020. However, participant race and ethnicity were still underreported.

Lead study author Chris A. Rees, MD, MPH, Division of Pediatric Emergency Medicine at Emory University, spoke of how addressing issues of representation could improve upon disparities in health care not only in the pediatric space but across all fields.

“Overall, as a field, it’s time that we start moving more towards solutions,” said Rees. “In our mind, this was an actionable way to include representation.”

In recent years, the subject of misinformation has pervaded many of our conversations regarding world news, politics and more. But how might it affect dermatology care, especially in the realm of social media?

A recent study from the University of California found that among 439 acne-related posts to the social media platform in April 2020, only 17 of the top posts came from dermatologists. The remaining posts were generated from “influencers” with no clinical background.

Influencers often received a greater average of “likes” despite dermatologists having a comparable number of followers, and often promoted skin care products that investigators noted were untested or showed no benefit of treating acne.

Despite this- or perhaps because of this- there are dermatologists such as Karan Lal, DO, MS, FAAD, Schweiger Dermatology Group, who have amassed a large following and continue to use Instagram to speak to clinically-relevant, properly research skin care methods.

Lal spoke to how he has used the social media platform to host a variety of conversations regarding dermatology care and broaden his reach for patients who might not always have all the appropriate resources.

How has sleep medicine changed in recent years, and what does the future hold? These are questions that are being asked this week at the World Sleep 2022 congress in Rome, Italy, and new data presented at the conference by Avadel Pharmaceuticals could provide a answers for patients struggling from narcolepsy.

A new post-hoc analyses for the sodium oxybate FT218 found that the therapy improved daytime sleepiness, sleep quality, and refreshing nature of sleep in patients with narcolepsy. It’s safety and efficacy was well established in the ongoing RESTORE study and the REST-ON trial, with participants receiving therapy for more than 18 months in the former.

In an interview with HCPLive, Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at Montefiore and professor of neurology at Albert Einstein College of Medicine, spoke of the implications of FT218 data in the realm of narcolepsy research and how pediatric patients with narcolepsy could benefit from the therapy in future trials.

The CDC proposed new clinical practice guidelines for prescribing opioids for pain management. These guidelines are not yet official as the government has opened the docket to obtain comments from the public regarding the proposed guidelines.

While the purpose of the guideline is to serve as a clinical tool for providers, the recommendations are voluntary. The CDC emphasized that they are intended as flexible standards of care and should not replace clinical judgment or individualized, patient-centered care.

The new clinical practice guideline, CDC Guideline for Prescribing Opioids–United States, 2022, expands on the previous one, CDC Guideline for Prescribing Opioids for Chronic Pain–United States, 2016, by including updated, evidence-based recommendations for clinicians.

The original guideline had a nationwide impact. Cindy Steinberg, National Director of Policy and Advocacy for the US Pain Foundation explains the changes and updates made to these proposed recommendations and how the process works.

Now that the recommendations are open on the Federal Register, public comments can be submitted for 60 days through April 11, 2022. After the comments are reviewed by the agency, a finalized version can be expected by the end of 2022.

Today is International Women’s Day, a global holiday officially recognized by the United Nations in 1975 with historical significance reaching as far back as the early 1900s.

It’s a day that celebrates the cultural, political, and socioeconomic accomplishments of women worldwide. For this episode of , DocTalk will be celebrating women in the healthcare system with Dr. Heather Brandling-Bennett

Dr. Brandling-Bennett is the Society of Pediatric Dermatology’s VP of Education & Career Development, as well as an Associate Professor at University of Washington and at Seattle Children’s Hospital.

In this conversation, she spoke of some of the advancements made by women in health care and what could be done to further support women in the workforce through proper compensation, promotions, and further recognition.

Sarcoidosis is a systemic inflammatory disease of unknown origin that is categorized by the formulation of granulomas in various parts of the body including the lungs, skin, heart, and brain.

Though the disease does not always require medication, careful monitoring and management is always recommended as it may present in fatigue, pain, small fiber neuropathy and other comorbidities.

Sarcoidosis is reported to affect roughly 30,000 patients yearly with a majority of those cases originating from the African American community. The disease is 3 times more common in African Americans patients compared White patients, and presents more frequently in African American women.

Ogugua Obi, MD, MPH, MSc, Director of the Sarcoidosis Center of Excellence at ECU, Assistant Professor at ECU, and member of the Scientific Advisory Board of the Foundation of Sarcoidosis Research (SAP), spoke of the disparities associated with the disease, the challenges patients face, and how sarcoidosis – the “great mimicker” as some clinicians have described it- can be differentiated from other diseases.

At HCPLive, we’ve had the incredible privilege of speaking with doctors from a variety of different clinical fields as well as different cultural, racial, and ethnic backgrounds. Without their dedication, insights, and generosity, the health care system and the world at large would be at a loss.

Even publications such as our own benefit from their work in a myriad of ways. In this episode of DocTalk, we offer listeners a glimpse of some of the most memorable and insightful interviews regarding skin of color, health inequities, and how clinical fields such as dermatology and rheumatology can improve care for Black and Brown patients and physicians alike.

This episode’s featured segments include: * Raj Chovatiya, MD, PhD, on diversifying clinical trials and other studies * Karan Lal, DO, MS, FAAD, on scientific literature dedicated to skin of color * Megha Shankar, MD, on avoiding labeling certain skin types as normal/abnormal * Ehizogie Edigin, MD, on the prevalence of systemic lupus erythematosus flares in African Americans * Titilope Fasipe, MD, PhD, on acknowledging deficiencies in sickle-cell care in Black patients

Across all areas of study in health care and especially in recent years, African American patients and physicians have experienced racial inequity regarding telemedicine practices across the US.

However, a new pilot trial from the Perelman School of Medicine at the University of Pennsylvania suggested subtle modifications in the methods of virtually engaging with Black patients that could be used to better communicate with populations affected by these inequities.

Data from the trial showed that Black patients with cardiovascular disease covered under Medicaid and Medicare insurance are significantly more likely to share blood pressure measures with a clinician through text messages as opposed to a healthcare system online portal.

Jennifer Lewy, MD, MPH, Director of the Penn Women’s Cardiovascular Center, spoke of the motives behind this trial as well as the uptake and acceptability of a text-based model for at-home blood pressure monitoring when compared to online virtual patient portals among Black patients with Medicaid or Medicare.

In early February, the American College of Rheumatology (ACR) announced an updated version of its COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases.

This update - the fifth of its kind- featured support for booster and supplemental doses in addition to recommendations regarding the timing of the injection as well as immunomodulatory medication use.

Revisions were also made regarding pre- and post-exposure prophylaxis with monoclonal antibody treatment, which are still supported by the guidance despite some limitations being issued by the US Food and Drug Administration.

In a statement made on the day of the announcement, Jeffrey Curtis, MD, MS, MPH, Chair of the ACR COVID-19 Vaccine Guidance Task Force, said that “There is now more nuance with supplemental and booster dose recommendations that should prompt us to ask patients not only whether they have been vaccinated, but with what, how many times, and how recently.”

Curtis recently sat down with HCPLive to speak of the main updates included in the newest version of the guidance and the implications of these changes for patients with rheumatic disease.

In this episode of DocTalk, we interview Janae Sharp, founder of the Sharp index, on some of these larger, slightly philosophical questions surrounding physician burnout, including how to measure and define success, as well as the deeper layers of stigma that must be addressed as part of the process.

Though sickle cell disease had been present in Africa for over 5000 years, it was first “discovered” in 1910 when a dental student named Walter Clement Noel became the first patient to be formally diagnosed. From there, more would be uncovered about the disease in the decades following his diagnosis, such as how it disproportionately affects patients of African descent.

According to the Centers for Disease Control and Prevention, about 1 in every 13 Black infants in the US are born with the trait for sickle cell disease. Additionally, diagnosis and screening for sickle cell are still lacking in lesser-resourced regions of Africa and the US alike.

Ifeyinwa “Ify” Osunkwo, MD, director of Sickle Cell Disease Enterprise at the Levine Cancer Institute and Professor of Medicine and Pediatrics at Atrium Health, spoke of advancements in the field of sickle cell disease including chronic disease-managing therapies, and how physicians unfamiliar with the disease could collaborate with hematologists to provide the best care for those affected by sickle cell.

In late January, a team of investigators from the Centers for Disease Control and Prevention (CDC) reported findings from the Vaccine Adverse Event Reporting System (VAERS) indicating a significantly low risk of myocarditis following vaccination with either available messenger RNA (mRNA) vaccine for COVID-19 in persons aged 24 years and younger.

Cases of the inflammatory heart event occurred 1626 times after an mRNA vaccine dose in US patients from December 2020 to August 2021.

Though the prevalence of myocarditis was deemed significantly low (.0000046%), it is something that Dr. Matthew E. Oster,MD, MPH, of the CDC and the Emory University School of Medicine says is worth taking note of.

Dr. Oster spoke of how the CDC is monitoring these events, as well as the risks to cardiac health that patients who aren’t vaccinated against COVID-19 face.

Today marks the fourth-ever National Women Physicians Day, an event that that is intended to pay respect to women physicians across the country. It’s held each year on Elizabeth Blackwell's birthday, who was the first female medical doctor in the United States.

Though much has changed since then, there are still fewer female doctors nationally than male doctors, an issue often caused by gender inequalities.

Dr. Marcia Klein-Patel, Chair of the Alleghany Health Network’s Women’s Institute, spoke of gender biases in the medical field, representation issues for women and minority groups in both professional and clinical areas, and what could be done to raise awareness and create a more inclusive and fair medical community.

Last week, Janssen announced results from a network meta-analysis (NMA) that showed that the biologic therapy guselkumab ranked highest for overall level of skin clearance. The NMA involved 33 phase 3 randomized clinical trials and 15 different targeted therapies including risakinumab and more.

Philip J. Mease, MD, director of rheumatology research at the Swedish Rheumatology Research Group, spoke of how the biologic distinguished itself from other targeted therapies in the network meta-analyses, and how these kinds of analyses could aid physicians in treating patients affected by psoriasis.

Prior to the COVID-19 pandemic, the subject of physician burnout was likely not considered or completely understood by large swaths of the American public. Despite this, burnout has been an issue that has plagued physicians for decades prior to the pandemic, and the consequences of it are far-reaching.

In an interview for the latest installment of Crisis Point with Connor Iapoce, Dr. Lakshmana Swamy detailed the history and complications of burnout and how the mental, physical, and emotional complications associated with it worsened with the COVID-19 pandemic.

Dr. Swamy described burnout as chronic work-related stress brought on by 3 key dimensions including emotional exhaustion, a lack of personal accomplishment, and depersonalization.

He spoke on how these dimensions were affected by the ongoing pandemic, and how physicians are coping with the onslaught on misinformation, distrust, and complications with the healthcare system.

In mid-January, Mount Sinai Health System and Icahn School of Medicine announced the launch of the Institute for Airway Sciences (IAS), a multidisciplinary institute intended to establish new therapies for patients with sinus, laryngotracheal airway, and lung diseases.

The institute will be opened under the guidance of Eric Genden, MD, MBA, Professor and System Chair of Otalaryngology, who spoke on how the institute will encourage new ways of approaching airway diseases through collaboration, grants and scholarship opportunities.

“The underlying goal (and) that the way that we do this is that instead of having a research institute in one silo, the clinical institute in another and then clinical trialists who are taking the signs and kind of trying and creating these trials, we're bringing them all together so that the scientists understand what are the problems that we're facing and they can get to work working with us on real pragmatic solutions,” Genden said.

In January, The American Red Cross reported that it was facing “its worst blood shortage in over a decade” amid surging cases of the Omicron variant of the COVID-19 virus. For the first time since its inception, the Red Cross declared a “Blood Crisis”, with blood and platelet donations reaching critically low levels.

Among those affected are patients with sickle cell disease.

Edward Ivy, MD, MPH, Vice Chief Medical Officer of the Sickle Cell Association of America (SCDAA), spoke of the implications of the blood shortage for patients with sickle cell disease, as well as promising new treatments that could be emerging in the coming years.

With Chronic Obstructive Pulmonary Disease (COPD) being cited as the third leading cause of mortality globally, the data surrounding the condition has naturally continued to broaden.

In high-income countries, COPD is predominantly typically linked to cigarette exposure, tobacco smoke and poor sleep habits.

However, people in low- and middle-income countries are often predisposed to a multitude of environmental factors that are not often considered outside of high-income settings.

Trishul Siddharthan, MD, Division of Pulmonary and Critical Care at the Miller School of Medicine, University of Miami, speaks of environmental exposures associated with low- and middle-income countries as well as the lack of diagnostic resources for COPD in these settings.

With the Centers for Disease Control and Prevention observing a steady increase in influenza cases early in the year, the subject of influenza vaccination has become increasingly prevalent.

Keipp Talbot, MD, MPH, Associate Professor of Medicine in the Division of Infectious Diseases at Vanderbilt University, sat down with HCPLive managing editor Kevin Kunzmann to discuss the most recent vaccine innovations that could come to influenza products.

DocTalk returns in 2022 with a discussion of the recent Food and Drug Administration (FDA) approval of tralokinumab for the treatment of moderate-to-severe atopic dermatitis in adult patients.

For this episode, Jonathan Silverberg, MD, PhD, MPH, discusses the ECZTRA trials, 3 phase 3 trials that evaluated the efficacy of the biologic as a monotherapy as well as a combination therapy with topical corticosteroids.

Tralokinumab is the first and only biologic approved by the FDA that binds to and inhibits the interleukin (IL)-13 cytokine, noted as a key driver of signs and symptoms of atopic dermatitis. Dr. Silverberg speaks on what this new treatment means for the future of atopic dermatitis management.

Dr. Jellinger joins the podcast to discuss the lipid section of the DCRM Multispecialty Practice Recommendations, as well the role of combination therapies and other concepts to lower LDL and what is coming next for the field of diabetes in 2022.

Donald Alcendor, PhD, joins to review currently available data surrounding the newest COVID-19 variant of concern, and shares guidance for concerned clinicians and the general public.

The Director of Retina Services at Wills Eye Hospital joins to discuss the historic FDA approval granted for a novel method of ophthalmic care: a permanent implant that allows for vision-saving formula therapy to treat the eye continually.

Read more about the PDS approval here.

Episode notes:

0:12 Intro

1:07 What is the Port Delivery System?

2:39 The history of developing the PDS

17:00 Is PDS exclusive to anti-VEGF?

19:52 Thoughts on the ranbizumab PDS approval

23:10 How will guidelines change?

24:15 Tips for best PDS use

26:30 Closing thoughts

29:40 Outro

Dr. Arianna Yanes provides insights into 7 new handouts developed by the Society for Pediatric Dermatology and how they aid nurses and teachers in creating a more inclusive setting for children with skin conditions.

Josh Mali, MD, of The Eyes Associates, joins HCPLive to review the key news and developments coming out of the American Society of Retina Specialists 2021 Scientific Meeting.

Dr. Childress said COVID-19 was difficult for many pediatric patients with ADHD

Dr. Paul Yang, of Casey Eye Institute, joins to discuss new ARVO 2021 data supporting the gene therapy for X-linked retinitis pigmentosa.

In a joint interview, 2 pediatric cardiologists discuss topics related to remote technologies and cardiological monitoring among pediatric populations.

The University of Chicago hypertension expert discusses new ADA recommendations for cardiovascular risk management.

The UCSF hematologist discusses the growing portfolio for the sickle cell therapy after ASH 2020.

Edmund Tsui, MD, talks the new AAO virtual format as well as presentations that have particularly caught his attention.

Dr. Yuen discusses some new treatments in the pipeline and how personalized medicine could make an impact in HBV treatment.

Alan Kaye, MD, PhD, joins DocTalk during Pain Awareness Month to discuss opioids, alternate pain therapies, and caring for patients with pain.

Dr. Cerulli discusses some ways ADHD can manage an upheaval in routine during COVID-19.

Dr. Mali talks about advancements in treatment and screening for Wet AMD.

Dr. Louis Kovacs and Dr. Evan Lipson discuss the risk of playing youth, college, and professional sports during the ongoing pandemic.

George Everly, PhD, discusses some of the pitfalls people face due to the ongoing pandemic.

In the latest edition of the DocTalk Podcast, Dr. Mark Smith talks about some of the issues related to the COVID-19 lockdown and how a second wave might psychologically impact individuals.

Dr. Ian Pavord discusses new meta-analyses of dupilumab planned for ATS 2020.

Panagis Galiatsatos, MD, MHS, joins to discuss the underlying issues and potential solutions to COVID-19 patient disparities.

Discussing a would-be ARVO 2020 presentation examining the use of anterior chamber intracameral dexamethasone drug-delivery suspen for postoperative inflammation in patients undergoing vitreoretinal surgery.

Investigators from Saint Louis University discuss their recent study comparing GLP-1 receptor agonists with SGLT2 inhibitors.

Clinical investigator and allergist Jonathan Corren, MD, shares insight on the TSLP inhibitor.

Al Rizzo, MD, CMO of the American Lung Association, discusses some of the biggest challenges and questions raised on lung health during the coronavirus pandemic.

Amy S. Paller, MD, principal investigator of the phase 3 LIBERTY AD PEDS trial, discusses the add-on biologic's benefit for young patients and potential as a pediatrc allergic therapy.

Dr. Kaneko, a cardiac surgeon at Brigham and Women's Hospital, breaks down a trio of studies he was associated with from ACC.20, including a look into PLO FLOW TAVR, the July Effect, and alternative access TAVR.

The ORION-11 principal investigator highlights new LDL-C reduction findings and teases future research for the siRNA-targeting drug.

Ralph Sacco, MD, chairman of the Department of Neurology and Olemberg Family Chair in Neurological Disorders Miller Professor of Neurology at the University of Miami, discusses advances in stroke care and his biggest takeaways from ISC 2020.

Anna Lembke, MD, discusses the history of the opioid epidemic.

A discussion on the state of rare disease with Sika Dunyoh, Director of Education Programs at the National Organization of Rare Disorders, for Rare Disease Day 2020.

A discussion on prescribing bempedoic acid in a real-world setting with steering committee chair Christie Ballantyne, MD, chief of Cardiology at Baylor College of Medicine.

David Lee, MD, discusses barbershop initiatives, their effectiveness, applicability in a real-world setting, and how they impact the health of a community as a whole.

Discussing recent TAVR news with Tsuyoshi Kaneko, MD, surgical director and director of outcomes research in the Structural Heart Program at the Brigham and Women's Hospital.

Michael Spigler, vice president of Patient Services and Kidney Disease Education for the American Kidney Fund, talks about the challenges and future of nephrology during Kidney Week.

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A conversation with Deepak Bhatt, MD, MPH, discussing the most impactful advances in cardiology in 2019 and what he sees as the most important advances in the past decade as 2019 comes to a close.

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Edmund Tsui, MD, social media editor for Ophthalmology, discusses some of the common pitfalls and advantages in the manner some physicians and clinicians navigate social media.

Dr. George Bakris, of the University of Chicago, discusses the impact of canagliflozin approval and how it impacts the current treatment of diabetic kidney disease.

The approval of oral semaglutide, an oral GLP-1 receptor agonist, could mark the beginning of a new era in the treatment of diabetes. We sat down with PIONEER investigator Vanita Aroda, MD, of Brigham and Women's, to learn more about the impact of this approval.

Discussing how changing seasons and weather impact allergy and asthma sufferers with Dr. Lakiea Wright, a board-certified allergist at Brigham and Women's and the medical director of US clinical affairs at Thermo Fisher Scientific. For more information and the latest news in allergy, asthma, and immunology care head to MDMagazine.com

Discussing the known facts and potential dangers of vaping and e-cigarette use with Albert Rizzo, MD, chief medical officer of the American Lung Association. For more information and the latest news in respiratory care, head to MDMagazine.com

Dhruv Kazi, MD, of Beth Israel Deaconess Medical Center, discusses a recent study he led examining use of polypill in several low- and middle-income countries. In this episode, Kazi shares his insights on the study and why polypill seems to be effective but has not become more popular as a treatment for CVD.

Discussing use of AI to determine overall physiological health through a 12-lead ECG. For more on AI in health and the latest in cardiology, be sure to head to MDMagazine.com

Discussing transcatheter aortic valve replacement with Dr. Tsuyoshi Kaneko and Dr. Sameer Hirji, both of Brigham and Women's Hospital. For more on TAVR and the latest in cardiology, be sure to head to MDMagazine.com