DocTalk Podcast

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! Interested in a more traditional, text rundown? Check out the HCPFive! 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 HCV The 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 Inflammation Prednisolone 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! Interested in a more traditional, text rundown? Check out the HCPFive! 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! Interested in a more traditional, text rundown? Check out the HCPFive! 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 Settings A 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 AMD The 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 Finds A 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 System The 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 Psoriasis New 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 XLRS The 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 Timestamps 00:00:06 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 Timestamps 00:05 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 becoming 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 occurring 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!

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.

Ahead of the American College of Rheumatology 2022 Convergence meeting on Nov. 10-14, our editorial team sat down with planning committee member Zsuzsanna McMahan, MD, MHS, of Johns Hopkins University School of Medicine, to take a deep dive into the upcoming meeting.

The FDA is expected to announce the final decision for the dual therapy AT-GAA, which uses miglustat in combination with cipaglucosidase alfa for treating Pompe disease, an inherited and often times fatal disorder. Expert Barry Byrne discusses the characteristics of the condition and what this FDA decision will mean for treatment.

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.