Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy Elevidys and growing scrutiny over the company’s transparency following multiple patient deaths. 

In this week’s episode of "The Top Line," we explore Sarepta’s brief standoff with the FDA over Elevidys, a short-lived marketing pause, and the regulator’s surprise reversal on the treatment. Fierce Pharma’s Fraiser Kansteiner and Angus Liu sit down with Fierce Biotech’s Gabrielle Masson to recap the story and discuss the broader implications the Elevidys saga may have for gene therapy, the FDA and the pharmaceutical industry.

To learn more about the topics in this episode: 

• Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning
• Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
• Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys
• FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
• Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death
• Roche won't throw in the towel after DMD gene therapy Elevidys' rebuff in Europe

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With an uptick in licensing deals and promising data emerging from China-based biopharmas, especially in oncology, it’s clear the country is poised to play a major role in life sciences for the foreseeable future.

In this week’s episode of "The Top Line," we trace China’s ascent in R&D and drug discovery and examine how U.S. and European drugmakers are capitalizing on the momentum through a surge in licensing activity.

Fierce Pharma’s Fraiser Kansteiner sits down with Mark Lansdell, director at Evaluate, to break down the policies fueling China’s growth, how global companies are engaging with Chinese assets and which modalities and indications are commanding the most attention.

To learn more about the topics in this episode: 

• China approves 4 new drugs, including a global first-in-class medicine
• With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugs
• China biotechs ‘reshaping’ US biopharma as outlicensing deals rise 11%: Jefferies report
• China proposes shorter clinical trial reviews in efforts to accelerate drug development

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In this episode of "The Top Line," Ayla Ellison, Editor-in-Chief of Fierce Life Sciences and Healthcare, sits down with two longtime industry leaders to talk about what it takes to stand out and grow in today’s pharma marketing landscape. 

Zoe Dunn, president and CEO of Hale Advisors, and Paul Murasko, head of digital innovation and marketing operations at Azurity Pharmaceuticals, reflect on how the industry has evolved—from print to digital to AI—and what early-career professionals need to know to thrive. As co-chairs of the Rising Stars program at this year’s Fierce Pharma Week, Dunn and Murasko share their insights on mentorship, innovation and how the next generation can navigate a highly regulated field while staying grounded in the fundamentals.

To learn more about the topics in this episode: 

• Fierce Pharma Week Information and Agenda
• Fierce Pharma Week Registration
• Rising Stars Program at Fierce Pharma Week 

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Layoffs in biopharma show no signs of slowing, with workforce reductions holding steady across the first two quarters of 2025.

In this week’s episode of "The Top Line," Fierce Deputy Editor Andrea Park and Fierce Biotech Senior Editor Gabrielle Masson break down the latest layoff trends and how they compare to last year.

Tune in for a look at the numbers so far, the pace of biotech closures and how federal policy shifts are affecting the industry.

To learn more about the topics in this episode: 

• Biopharma layoffs for first half of the year jump 32% YOY
• Fierce Biotech Layoff Tracker 2025

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In the latest episode of the Health Matters podcast, Wendy Lund sits down with Peter Pitts, former FDA associate commissioner and current president of the Center for Medicine in the Public Interest, to discuss the state of regulatory science and communication in health care. Pitts shares a cautiously optimistic outlook for the FDA under Commissioner Makary, noting the agency's renewed focus on innovation, patient engagement and modernization. He also stresses the importance of alignment among marketing, legal and regulatory teams—what he calls “regulatory therapy”—to ensure health communications serve the public good.

The conversation spans high-stakes topics such as direct-to-consumer advertising, misinformation, and missed PDUFA dates, with Pitts urging both regulators and industry leaders to improve transparency and collaboration. He calls on pharmaceutical companies to put patients first in communications and avoid blaming the FDA when approvals stall. Pitts also encourages the agency to learn from industry on how to better engage the public. For more insights—and a candid look at where the health care conversation needs to go—tune in to the full episode.

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Two and a half years into his tenure as Teva’s CEO, Richard Francis is breaking down the strategy that’s powered the company through nine consecutive quarters of growth.

On this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with Francis to talk about the progress made so far on Teva’s “Pivot to Growth” strategy and what comes next. They dig into the strategies behind the company’s chief commercial medicines, its pipeline darlings and the way Teva’s generic and biosimilar backbone is expected to evolve through the end of the decade. 

To learn more about the topics in this episode: 

• As Austedo, Ajovy and Uzedy gain steam, Teva banks on $5B-plus in 2030 innovative drug sales
• Teva plots thousands of job cuts as restructuring drive enters 'acceleration' phase
• Teva taps Matthew Shields to oversee manufacturing and supply division amid company revamp

This week's episode is sponsored by Cencora. 

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Antibody drug conjugates, or ADCs, are still holding on to their spot as one of the hottest areas in cancer care—and AbbVie, like many of its peers, has embraced the trend head-on.

In this week’s episode of "The Top Line," Fierce Pharma’s Zoey Becker speaks with Daejin Abidoye, M.D., AbbVie’s vice president and therapeutic area head for solid tumor oncology. They discuss the company’s evolution, trends from this year’s American Society of Clinical Oncology meeting and what’s ahead for ADCs in oncology.

AbbVie, a newer player in the ADC space, recently earned FDA approval for Emrelis in adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy. With a robust pipeline of ADCs in development, Abidoye envisions a bright future for the class—one that could herald “a new era” of cancer treatment beyond traditional chemotherapy.

To learn more about the topics in this episode: 

• AbbVie advances solid tumor agenda with FDA nod for lung cancer ADC Emrelis
• AbbVie pays $10B to acquire ImmunoGen, doubling down on red-hot ADC cancer field
• Replacing chemotherapy with ADCs? AbbVie rebuilds next-gen assets after Rova-T flop

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Every year, the Fierce Medtech team highlights 15 standout companies that are pushing the boundaries of innovation in medical technology. From reinventing diagnostics and surgical tools to advancing AI and biological research, this year’s Fierce 15 is full of startups rethinking what care should look like—and improving on what came before.

In this episode of "The Top Line," Fierce Medtech Senior Editor Conor Hale breaks down the themes and standout trends from this year’s list, offering a closer look at the ideas and technologies reshaping the healthcare landscape.

To learn more about the topics in this episode: 

• Introducing Fierce Medtech's Fierce 15

This episode is sponsored by Cencora. 

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Each year, the American Society of Clinical Oncology annual meeting brings together the biggest names and brightest minds in cancer research, and this year was no exception.

In this episode of "The Top Line," Fierce reporters take you inside the action at ASCO 2025. Zoey Becker shares the story behind Johnson & Johnson’s dramatic “Breathtaking” campaign, staged on the 99th floor of Chicago’s Willis Tower. Angus Liu breaks down phase 3 data on Enhertu from AstraZeneca and Daiichi Sankyo, while Gabrielle Masson overviews Bicara Therapeutics' investigational asset for head and neck squamous cell carcinoma. 

Plus, the team compares notes from the ASCO exhibit hall.

To learn more about the topics in this episode: 

• ASCO: AstraZeneca, Daiichi flex Enhertu's muscles in first-line breast cancer as they drop new phase 3 gastric cancer data
• 'Our data is resonating far more with the people that matter,' Bicara CEO says amid Merus race
• ASCO: J&J highlights Rybrevant-Lazcluze combo in 'Breathtaking Moments' lung cancer campaign high over Chicago skyline

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In this episode of The Top Line, Fierce Biotech’s Chris Hayden sat down with Dr. Juergen Eckhardt of Bayer and Dr. Seth Ettenberg of BlueRock Therapeutics to discuss an innovative partnership that’s reshaping how big pharma teams up with biotech startups.

BlueRock, a wholly owned subsidiary of Bayer, operates with the independence of a small biotech while benefiting from Bayer’s global reach and infrastructure. The “arm’s-length” model gives BlueRock the agility to innovate while leveraging Bayer’s resources in manufacturing, clinical trials and commercialization.

The collaboration has already led to major milestones, including the development of a promising cell therapy for Parkinson’s disease, which is expected to enter Phase 3 trials later this year.

“This isn’t just a partnership—it’s a relationship,” Eckhardt said. “We’re combining the best of both worlds: biotech speed and pharma scale.”

The episode also explores how Bayer’s experience in biologics manufacturing has helped BlueRock overcome one of regenerative medicine’s biggest challenges—scaling complex cell therapies. The model has proven so effective that Bayer has since replicated it with other companies, signaling a broader shift in how the company approaches innovation.

To learn more about this unique partnership and what it means for the future of neurological disease treatment, listen to the full episode of The Top Line.

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