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BioSpace

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Fréquence : 1 épisode/181j. Total Éps: 257

Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

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Kennedy’s Vaccine Agenda Stalled, Structure’s ‘Competitive’ Obesity Pill, Novo’s Warning Letter

mercredi 18 mars 2026 • Durée 20:08

Biopharma’s weight loss warriors have led the news this week, with Structure Therapeutics and Rhythm Pharmaceuticals announcing new data. Structure delivered a “competitive profile” for its investigational GLP-1 pill compared to Eli Lilly’s orforglipron and Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote to investors, after the candidate elicited 16.3% weight loss after 44 weeks in a Phase 2 trial. Rhythm was not as successful, announcing that Imcivree failed in a Phase 3 basket trial of various genetically driven obesities.

Meanwhile, Lilly and Novo made headlines outside of the clinical realm, as Lilly warned the public of the potential safety risks of taking compounded versions of tirzepatide—marketed as Zepbound for obesity and Mounjaro for type 2 diabetes. And Novo was hit with an FDA warning letter for failing to investigate reported adverse events—including three deaths—potentially linked to its own diabetes drug Ozempic. The letter only adds to what has been a challenging recent run for Novo, one that led to a 34% drop in total assets under management for its controlling shareholder Novo Holdings.

On the regulatory front, Robert F. Kennedy Jr.’s vaccine agenda is stalled after Massachusetts District Court Judge Brian Murphy found that his efforts to overhaul policies in this area were likely unlawful. Murphy specifically cited Kennedy’s move last June to empty the CDC’s Advisory Committee on Immunization Practices (ACIP). This comes on the heels of a White House crackdown in which officials would like the health secretary to tone down his vaccine skepticism, according to a report by The Wall Street Journal.

At the FDA, tensions continue to escalate, with Sen. Ron Johnson (R-WI) launching an investigation into recent rejections of rare disease drugs. And transparency issues have come to light once again regarding the circumstances around biologics chief Vinay Prasad’s imminent departure and recent request to remain anonymous during a media briefing about uniQure’s gene therapy for Huntington’s disease.

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UniQure’s Delay, REGENXBIO’s Rejection Explained, Sarepta’s Ingram Steps Down, More

mercredi 4 mars 2026 • Durée 23:37

The FDA is dominating the headlines once again thisweek.

Days after FDA Commissioner Marty Makary appeared to question uniQure’s gene therapy candidate for Huntington’s disease, the company revealed that the agency will require it to conduct a randomized, double-blind, sham surgery–controlled Phase 3 study. The FDA also published anothercomplete response letter (CRL), this one for REGENXBIO’s gene therapy for Hunter syndrome. The rejection, sustained by the biotech early last month, was driven by issues with the study’s population, controls and use of surrogate markers to measure efficacy, according to the document.

Meanwhile, regulatory experts have expressed concernsthat the FDA’s circle of trust is shrinking, making many decisions feel like “fiat”—both in terms of individual drug applications and policy. The FDA has reportedly initiated a probe into complaints that a toxic workplace is fostered by CBER director Vinay Prasad, who is at the heart of many of these decisions. Finally, the biopharma industry continues to react to the agency’s pivot from a requirement of two pivotal trials to one for approval, asking why now, what are the risks and what exactly the FDA expects from this one trial.

Still on the gene therapy front, Sarepta Therapeutics CEO Doug Ingram stepped down last week to spend more time with family as the company’s muscular dystrophy mission hits home. Also during the company’s fourth quarter earnings call, that sales of its embattled Duchenne muscular dystrophy gene therapy Elevidys will be flat or down as far as 15% in 2026.

Sarepta Gets Reprieve, RFK Jr.’s New Changes, Roche’s Alzheimer’s Comeback and Q2 Earnings

mercredi 30 juillet 2025 • Durée 19:17

The Sarepta saga continued into another week as the FDA recommended that the voluntary hold on the company’s Duchenne muscular dystrophy gene therapy be lifted for ambulatory patients, after determining that the death of an 8-year-old Brazilian Duchenne patient who had received Elevidys’ was not caused by the drug. Sarepta’s stock has swung wildly and its transparency questioned after it elected not to reveal the death of a third patient—a participant in a trial of a gene therapy for limb girdle muscular dystrophy—during a business update last week.

Speaking of entities—or individuals—who have trouble staying out of the news, Health Secretary Robert F. Kennedy Jr. plans to dissolve the U.S. Preventive Services Task Force because it is “too woke.” Also on Monday, Kennedy addressed what he called the “broken” vaccine injury compensation program. Without offering details, he vowed to “fix” the U.S.’s VICP and return it to its “original Congressional intent.”

On the business side of the biopharma house, Q2 earnings are in full swing, with AstraZeneca announcing estimate-beating numbers and CEO Pascal Soriot saying the world “needs to share” in global pharma R&D, while Merck cut $3 billion to support an aggressive launch schedule. Meanwhile, a week ahead of its own earnings report, Novo Nordisk named a new CEO and lowered its 2025 sales guidance for the second time this year.

Where Do We Go From Here? The Future of Women's Health

jeudi 25 avril 2024 • Durée 22:24

The potential impacts on clinical trial outcomes warrant a discussion surrounding the current definition of women’s health.

In the second episode on our series on women's health, we discuss what may happen to future generations if women, the custodians of generational health, are not comfortable sharing complete medical histories. Additionally, we discuss how broadening the definition will open funding to address women’s health.

Host

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, ⁠BioSpace⁠

Guests

⁠Sans Thakur⁠, Founder and Chairwoman of ⁠Tower Capital⁠

⁠Chia Chia Sun⁠, Chief Commercial Officer at ⁠Fab Biopharma⁠

⁠Elisa Cascade⁠, Chief Product Officer of at ⁠Advarra⁠

Shawana Moore, Medical Advisor on the ⁠Advisory Council for Healthy Women⁠

⁠Katie Schubert⁠, President and Chief Executive Officer of the ⁠

Beyond the Gluten-Free Diet: A New Era in Celiac Disease Treatment

jeudi 11 décembre 2025 • Durée 40:21

In this episode presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, professor of medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, and Department of Immunology, The Mayo Clinic; Marilyn Gellar, CEO, The Celiac Disease Foundation; and Dr. Paul Lizzul, chief medical officer, AnaptysBio, about the unmet need for effective treatments for celiac disease, the limitations of the gluten-free diet and the development of ANB033, a first-in-class CD122 antagonist designed to modulate IL-2/IL-15 signaling.

Host

Jennifer Smith-Parker, Director of Insights, BioSpace

Guests

Dr. Joe Murray, Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine and Department of Immunology, The Mayo Clinic

Marilyn Geller, CEO, Celiac Disease Foundation

Dr. Paul Lizzul, Chief Medical Officer, AnaptysBio

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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Modernagate Fallout, Disc’s Rejection, Compass’ Psilocybin Data, CDC’s Lost Leaders

mercredi 18 février 2026 • Durée 20:42

Last week, the FDA declined to review Moderna’s mRNA-based flu vaccine, with Center for Biologics Evaluation and Research Director Vinay Prasad himself signing the refuse-to-file (RTF) letter. Prasad said Moderna’s comparator group “does notreflect the best-available standard of care,” while Moderna pushed back, saying CBER had previously found a standard-dose flu shot to be an “acceptable” comparator. Despite the shocking turn of events, HHS backed Prasad, saying Moderna didn’t “follow very clear FDA guidance from 2024.”

Regardless of the reasons, the development imperilsModerna’s breakeven plans, affecting not just the company’s investigational flu vaccine but also a flu-COVID combo shot and other parts of the company’s pipeline. And for the broader industry, it highlights the regulatory uncertainty that persists into 2026, even as other countries move full speed ahead with novel modalities.

That regulatory uncertainty extended this week to DiscMedicine, whose rare disease drug bitopertin was rejectedby the FDA. The company tried to convince investors that its planned Phase 3 trial would pave the way toward a refiling, but analysts raised concerns that the study was developed with oldFDA leadership. Disc’s situation also raises questions about the FDA’s Commissioner’s National Priority Voucher, which bitopertin had received.

How Biotech Funding is Changing Executive Search and Hiring Processes

jeudi 13 novembre 2025 • Durée 21:13

A lean funding environment has changed how biotechs approach workforce organization and executive hiring. Searches are becoming more targeted and intentional, and accountability–both for employers and candidates–is high. In this episode of Denatured, Leslie Loveless of Slone Partners describes how biotechs should approach building their executive teams, working with boards and investors to make decisions that will enable growth. She also discusses how the search and hiring processes has changed for both employers and candidates.

This episode is presented in partnership with Slone Partners.

Host

Chantal Dresner, Vice President of Marketing, BioSpace

Guest

Leslie Loveless, Co-CEO and Managing Partner, Slone Partners

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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From Two Trials to One, Sponsors Face a Higher Standard

jeudi 12 mars 2026 • Durée 21:20

In this episode of Denatured, you'll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA's latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.

Host

⁠Jennifer C. Smith-Parker⁠, Director of Insights, BioSpace

Guests

Oxana Iliach, Senior Director of Regulatory Strategy, Certara

Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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Corsera Eyes Two-Pronged Approach To Tackle Leading Cardiovascular Killer

mardi 24 février 2026 • Durée 17:33

Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care in this special bonus episode.

Corsera Health is featured in BioSpace's NextGen: Class of 2026 list, the top startups to watch in the U.S.

Host

Annalee Armstrong, Senior Editor, BioSpace

Guests

Rena Denoncourt, Chief Operating Officer, Corsera Health

Meredith Kaya, Chief Financial Officer, Corsera Health

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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Bonus: Q4 2025 Job Market Update

lundi 19 janvier 2026 • Durée 07:49

In this episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss Q4 2025 job market performance, sharing the latest BioSpace data. They touch on positive signs they saw last quarter and what this year might have in store for those seeking employment.

Want to receive our latest quarterly job market reports as soon as they’re published? ⁠⁠⁠Subscribe⁠⁠⁠ to Career Insider for our job market updates, job trends, career advice and more.

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BioSpace – Détails, épisodes et analyse

Détails du podcast

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The Guardian1

Qualité et score du flux RSS

Historique des publications

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Podcasts Similaires Basées sur le Contenu

Apple Podcasts

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The Guardian1