The Top Line

With a new president of U.S. pharma at the helm—and two key FDA approvals now in the books—Boehringer Ingelheim is sharpening its focus on the lucrative American market. In this week’s episode of “The Top Line,” we dive into Boehringer Ingelheim’s latest regulatory successes, two crucial launches, and the German company’s expanding commercialization push in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Brian Hilberdink—who joined Boehringer as president of U.S. human pharma in February—to discuss his game plan to further unlock the American market and capitalize on key BI green lights in idiopathic pulmonary fibrosis and lung cancer. To learn more about the topics in this episode:  Boehringer Ingelheim breaks into oncology with FDA approval for lung cancer med Hernexeos Boehringer Ingelheim breathes new life into lung fibrosis field with FDA approval for Jascayd 'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline Chutes & Ladders—Boehringer snatches up LEO exec for US pharma team See omnystudio.com/listener for privacy information.

Artificial intelligence is reshaping drug safety, but governance is just as critical as innovation, according to Marie Flanagan of IQVIA Safety Technologies. Speaking on The Top Line podcast, Flanagan said responsibility for AI in healthcare must be shared across compliance, technology, business teams and regulators. Strong governance, she said, ensures AI systems are ethically designed, technically validated, transparent and adaptable to continuous oversight. Organizations can prepare by grounding their strategies in guiding principles such as human oversight, fairness and accountability, Flanagan said. She emphasized the need to embed governance in AI design from the start, rather than adding controls later. Compliance teams, she added, can shift from being seen as barriers to acting as enablers of safe innovation. From constant monitoring to feedback loops, the conversation highlights practical steps for managing AI in life sciences. Hear the full episode of The Top Line for a deeper look at how companies can balance innovation and responsibility.See omnystudio.com/listener for privacy information.

Tariffs, drug pricing reform, a government shutdown and a major turnover at one of the world’s largest drugmakers all converged this week, leaving plenty to unpack for the industry as it heads into fall. Greater clarity on President Donald Trump’s tariff and pricing strategies has likely come as something of a relief for those companies operating in the U.S., but that news was tempered by a shutdown of the federal government on Wednesday. Meanwhile, big changes are likely on the way at GSK, whose longtime CEO Emma Walmsley is headed for the exit. In this week’s episode of "The Top Line," we break down some of the biggest stories across Fierce Pharma for the week—which may very well be some of the biggest stories of the year—touching on critical policy updates in the U.S., the furloughing of federal employees at agencies like the FDA and NIH and the imminent departure of GSK’s chief executive. Fierce Life Sciences’ Ben Adams sits down with Fierce Pharma's Fraiser Kansteiner to discuss the latest headlines and go over the key points from each major development that has played out. To learn more about the topics in this episode:  FDA avoids the worst amid government shutdown, but new applications put on hold NIH research grinds to a halt as government shuts down Pfizer offers price concessions, $70B US outlay in Trump's 'most favored nation' push Trump's pharma tariffs on hold amid administration's effort to secure pricing concessions, industry investment: Stat GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels See omnystudio.com/listener for privacy information.

Despite a challenging year, the biotech industry has continued to push boundaries, taking bold risks in pursuit of groundbreaking science. If anything, this year has only strengthened our conviction in the rising stars leading the next wave of innovation.   Fierce Biotech’s Fierce 15 class of 2025 is defined by their resilience, diversity in both strategy and leadership, and treatments that hold life-changing potential for underserved patients around the world.   In this week’s episode of "The Top Line," Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Andrea Park discuss what went into picking this year’s winners and some highlights from the special report.  To learn more about the topics in this episode:  Introducing Fierce Biotech's 2025 Fierce 15 See omnystudio.com/listener for privacy information.

Trust in pharma has always been fragile, and the rise of misinformation has made it even more precarious. In this episode of "The Top Line," recorded at Fierce Pharma Week in Philadelphia, Freda Lewis-Hall, M.D., joins us to share how she has worked to put a human face on the industry. A psychiatrist, longtime patient advocate and former Pfizer chief medical officer, she explains why listening must come before messaging, how AI and omnichannel outreach can help or harm patient trust and why rebuilding credibility starts one conversation at a time. To learn more about the topics in this episode:  TV ads close to overtaking doctors as consumers' primary source for learning about new meds: survey Pharma's reputation is stable-ish. Will that survive Trump 2.0? ABPI finds familiarity breeds trust, supporting push for industry-healthcare collaborations Doctor Mike calls on healthcare, pharma leaders to lean into social media to rebuild trust with patients See omnystudio.com/listener for privacy information.

Robert Abel, chief scientific officer at Schrödinger, says advanced computational tools are changing the pace and accuracy of drug discovery. In a recent episode of The Top Line podcast, Abel outlined three areas where AI and machine learning are making the greatest impact: understanding disease biology, predicting protein structures and designing drug molecules. Schrödinger’s platform uses physics-based simulations alongside AI to evaluate millions of molecules in days, compared with the thousands traditionally synthesized in a year. Abel pointed to real-world results, including a program that reached a clinical trial candidate in just 10 months — far faster than industry averages. He said the technology also helps overcome challenges such as improving drug selectivity and reducing the need for animal testing, aligning with FDA priorities. Abel will share more insights during his upcoming talk at AAPS PharmSci 360 in San Antonio this November. His session abstract is available here. To hear more about Schrödinger’s work in computational drug discovery, listen to the full interview.See omnystudio.com/listener for privacy information.

With Pfizer discontinuing Beqvez and BioMarin scaling back the commercial focus of Roctavian, the curative promise of hemophilia gene therapies is tempered by significant barriers that discourage widespread adoption. In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker speaks with Glenn Pierce, M.D., Ph.D., vice president of medical at the World Federation of Hemophilia, about the complexities behind these innovative therapies and the multifaceted reasons for their slow uptake. Pierce discusses the competitiveness of the current hemophilia gene therapy market, why Pfizer’s product couldn’t keep up, and the patient populations that risk being left behind. To learn more about the topics in this episode:   As Pfizer backs out of hemophilia gene therapy space, CSL hopes Hemgenix is here to stay  Pfizer discontinues hemophilia treatment Beqvez, emptying its gene therapy portfolio  BioMarin downsizes Roctavian efforts but keeps hemophilia gene therapy for 3 markets  See omnystudio.com/listener for privacy information.

Hope, when applied with purpose and action, can be a powerful force for driving change in healthcare. That’s the philosophy of Eugene Woods, CEO of Advocate Health and a 2025 Fierce 50 honoree, who joins Ayla Ellison, Editor-in-Chief of Fierce Life Sciences & Healthcare, to share how he puts “Applied Hope” into practice. Woods explains how this approach combines optimism with action and why it’s become a guiding strategy for one of the nation’s largest nonprofit health systems. In their conversation, Woods discusses leading through massive organizational change, cultural transformation and the rapid adoption of new technologies. He offers insights on improving quality and affordability, investing in both rural communities and urban neighborhoods and preparing for a future shaped by AI and more human-centered healthcare delivery. To learn more about the topics in this episode:  Fierce 50 of 2025 Eugene A. Woods—Fierce 50 Leadership Honoree See omnystudio.com/listener for privacy information.

In the latest episode of the Health Matters podcast, former Food and Drug Administration Commissioner Scott Gottlieb joins WPP’s Wendy Lund, GCI Health’s Ryan Kuresman and Burson’s Judy Stecker to discuss the forces reshaping U.S. health policy. Gottlieb warns that while new laws such as the Inflation Reduction Act may lower government spending on drugs, consumers are unlikely to see significant relief at the pharmacy counter. Insurers’ tighter formularies and higher cost-sharing requirements, he said, could continue to drive affordability challenges for patients. The discussion also covers the future of direct-to-consumer advertising, FDA’s role in combating health misinformation and the promise of cell and gene therapies. Gottlieb shares both caution and optimism — noting the risk of consumer frustration if policy changes fail to deliver savings, while pointing to breakthroughs that are transforming treatment and outcomes. To hear his full take on the challenges and opportunities facing health care leaders, listen to the full Health Matters episode.See omnystudio.com/listener for privacy information.

After many U.S. biopharma companies posted sales declines in the first quarter, the domestic pharma industry largely bounced back to growth in the second quarter.  In this episode of "The Top Line," Fierce Pharma's Eric Sagonowsky and Kevin Dunleavy break down the numbers behind the industry’s second-quarter performance. Among U.S. pharma heavyweights, J&J, AbbVie, Pfizer, Regeneron, Bristol Myers Squibb and Biogen each eked out gains this past quarter. Their results varied, with individual stories worth highlighting at each of these major companies. Beyond earnings, Sagonowsky and Dunleavy also discuss the growing competition in diabetes and obesity treatments between Eli Lilly and Novo Nordisk, as well as Merck’s rising financial reliance on its blockbuster cancer drug Keytruda, among other topics.  To learn more about the topics in this episode:  Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year The battle of the obesity drug heavyweights 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Biopharma briefing: Q1 trends, gene therapy updates and ASCO preview  See omnystudio.com/listener for privacy information.

While it’s been easy to grow a bit desensitized to the seemingly unstoppable sales growth of Novo Nordisk and Eli Lilly’s GLP-1s quarter after quarter, this most recent earnings season delivered a few surprises. It’s a good moment to jump back in and assess where the two rivals stand in the market and where their pipelines are headed in the near term. In this week’s episode of "The Top Line," we break down the recent commercial performances of Novo’s and Lilly’s drugs for diabetes and obesity, plus the status of their oral obesity med prospects. Fierce Biotech’s James Waldron sits down with Fierce Pharma’s Fraiser Kansteiner to discuss the latest in the companies’ ongoing obesity duel, as well as some recent pitfalls that seem common to GLP-1 development and commercialization more broadly. To learn more about the topics in this episode:  Novo's outgoing CEO prepares to hand off business as sales threats from Lilly, GLP-1 compounders persist Amid MFN talks, Lilly chief warns US adoption of international drug prices could bring 'worst of two worlds' Novo Nordisk drops 2 obesity drugs as part of major pipeline clearout Lilly's oral GLP-1 data 'as good as it gets' at 12% weight loss, exec says Pfizer's embattled obesity program loses another GLP-1 over poor data and strong competition See omnystudio.com/listener for privacy information.

Following a barrage of letters from President Donald Trump urging 17 large pharmaceutical companies to implement Most Favored Nation drug pricing reforms in the U.S., analysts and industry watchers are questioning how far the president’s authority extends, while several drugmakers have signaled a willingness to negotiate. In this week’s episode of "The Top Line," we break down the latest Most Favored Nation pricing pressures in the U.S., how companies are responding and which facets of the proposal might fall short of Trump’s goals. Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss the current state of those reform efforts and past attempts to rein in U.S. drug costs, followed by a brief discussion on tariffs. To learn more about the topics in this episode:  Pfizer CEO touts 'extremely productive' talks with Trump administration as MFN pricing, tariff threats close in White House threatens to 'deploy every tool in our arsenal' to implement most-favored-nation drug pricing All branded drugs not facing generic, biosimilar competition must abide by MFN order in 'all markets,' HHS tells pharma Trump ups the ante on pharma tariffs, saying they will reach 250% See omnystudio.com/listener for privacy information.

In the latest episode of Health Matters, vaccine expert Dr. Paul Offit joins host Wendy Lund to discuss the growing crisis of vaccine hesitancy and what can be done to rebuild trust. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, points to the COVID-19 pandemic as a turning point, citing perceived government overreach and widespread misinformation as key drivers of public distrust. He emphasizes that vaccine hesitancy is often rooted in reasonable concerns and calls on health care professionals to respond with empathy, not judgment. Offit also outlines steps the industry can take to regain credibility, including amplifying trusted community voices, improving science communication, and putting a human face on pharmaceutical innovation. He shares moving stories from the field, including one about Dr. Penny Heaton’s work to develop a rotavirus vaccine and bring it to children in need. “We all want the same thing,” Offit says. “Healthy children, protected from preventable diseases.” Listen to the full episode for more insights on how the health care sector can meet this moment with clarity and compassion. Disclaimer:  All information provided on this podcast is for informational purposes only and does not constitute medical advice. You should consult with qualified healthcare professionals before making any decisions related to your health. Any opinions expressed are those of the individuals expressing them and do not represent the views of the podcast or its affiliates.See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.

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  See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.

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.See omnystudio.com/listener for privacy information.

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. See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.