The Top Line

Bayer is reshaping its pharmaceutical business with a new operating model designed to enhance collaboration and bring research & development and commercialization closer together. In a recent episode of The Top Line podcast, Bayer executives Christine Roth, Executive Vice President and Head of Global Product Strategy and Commercialization, and Dr. Yesmean Wahdan, Head of Medical Affairs for the United States and North America, discussed how the company’s Dynamic Shared Ownership framework is driving faster innovation and helping accelerate the development of new therapies for patients. The model removes traditional hierarchies, empowers cross-functional teams and encourages real-time collaboration across departments. Roth and Wahdan said the approach has already shortened regulatory timelines, reduced resource use and helped deliver treatments to patients sooner. By embedding commercial insights early in the research process, Bayer teams can anticipate market needs and focus on the greatest areas of unmet medical demand. The leaders said the company’s collaborative culture keeps patient benefit at the center of decision-making. To learn more about how Bayer’s model is transforming its pipeline, listen to the full episode of The Top Line. See more from Bayer’s Christine Roth and Dr. Yesmean Wahdan on their LinkedIn profiles below: Christine: https://www.linkedin.com/in/christine-roth-34b07b18/ Yesmean: https://www.linkedin.com/in/yesmean-h-wahdan-md-71409b199/ See omnystudio.com/listener for privacy information.

In this episode of The Top Line, Fierce’s Chris Hayden speaks with Foresight Diagnostics co-founders Dr. Jake Chabon and Dr. Max Diehn about how their company is delivering the next generation of minimal residual disease (MRD) detection in cancer care. Born from research at Stanford University, Foresight’s PhasED-Seq technology delivers ultra-sensitive detection—down to parts per ten million—enabling clinicians to identify microscopic traces of cancer that traditional imaging misses. The discussion explores how Foresight’s MRD platform, CLARITY, can have the ability to support more confident decision-making, from determining curative success in early-stage cancers to guiding consolidation treatment in lymphoma. Chabon and Diehn highlight the company’s biopharma collaborations, clinical trial integration, and evidence-driven approach to guideline inclusion. They also look ahead to a future where MRD testing becomes central to oncology surveillance, accelerating therapy approvals and complementing genomic and digital pathology tools to advance precision medicine.See omnystudio.com/listener for privacy information.

In this week’s episode of "The Top Line," we take a deep dive into the top-line performance of the biopharma industry in the third quarter. After a slow start to the year, U.S. drugmakers in particular have recovered, led by Eli Lilly. We examine which companies are hot and which are not. We also look at trends that emerged in the third quarter, such as the shortfall in vaccine sales, especially in the U.S., and companies’ sales projections for the rest of the year. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss their observations from the third quarter and put the industry’s performance in perspective compared with previous quarters. They also examine the biopharma outlook for the fourth quarter. To learn more about the topics in this episode: Q1 biopharma layoff trends, plus expectations for Q2 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year See omnystudio.com/listener for privacy information.

As the prospect of import tariffs and drug price reform marshals billions of biopharma investment dollars into the U.S., the feasibility of rapid domestic manufacturing buildouts could hinge on a new program cooking at the FDA. How that program, dubbed PreCheck, will work in practice—and on what timeline—are key questions as the U.S. looks to bolster its local pharmaceutical production base. This week on “The Top Line,” we dive into comments from a recent public meeting on the industry’s hopes for PreCheck, which is being designed to streamline the process by which new biopharma manufacturing facilities are built in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics—who attended the meeting—to offer an on-the-ground perspective and explore the aspects of the plan that could have the biggest impact on manufacturers. Shilling also outlines what he sees as FDA’s next steps, plus regulatory considerations that could most benefit CDMOs and the broader industry. To learn more about the topics in this episode: Amid tariff-fueled onshoring push, Trump signs order to boost US stockpiling of certain drug ingredients FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing Amid pharma's US investment spree, FDA unveils new program to streamline domestic plant build-outs Trump signs executive order to boost US drug manufacturing amid threat of tariffs See omnystudio.com/listener for privacy information.

The healthcare marketing landscape is evolving fast — shaped by regulatory shifts, patient empowerment, and the rise of digital health marketplaces. In this episode of The Top Line, sponsored by Havas Media Network, host Chris Hayden sits down with Holly Dunn, Managing Partner of Performance at Havas Media Network, to explore how pharma brands can redefine patient engagement for a more connected, equitable future. Dunn explains how first-party data, AI-driven intent signals, and curated health marketplaces are enabling more compliant, transparent, and human-centered campaigns. She also discusses the growing role of healthcare creators, the fight against misinformation, and strategies to ensure high-quality, privacy-safe engagement across the patient journey. If you’re in pharma or biotech marketing, this conversation offers critical insight into how leading brands are building trust and equity in an increasingly complex environment.See omnystudio.com/listener for privacy information.

Welcome to the Fierce Biotech Graveyard, our annual ritual remembering the biotechs we lost in 2025 and those on the brink. In this episode, Fierce Biotech’s Darren Incorvaia and Gabrielle Masson came together to chat about themes from this year’s graveyard, including a cell therapy mausoleum, some mad science, and Darren’s incredibly dated reference to a novelty song from 1958. To learn more about the topics in this episode: The 2025 Biotech Graveyard See omnystudio.com/listener for privacy information.

This week's episode of "The Top Line" features a discussion about what’s working now in biotech and what isn't. Recorded Oct. 7 at Fierce Biotech Week, this panel featuring leaders from past Fierce 15 winners digs into timelines, partnerships, what's hype, what's signal and how teams are pressure-testing their models in today's market. You'll hear from Generate Biomedicines CEO Mike Nally, Arbor Biotechnologies Chief Scientific Officer John Murphy, Epicrispr Biotechnologies CEO Amber Salzman, Ph.D., and Parabilis Medicines Chief Business Officer Greg Miller. The conversation was moderated by Fierce Biotech's Gabrielle Masson. To learn more about the topics in this episode: Fierce Biotech's 2022 Fierce 15 Fierce Biotech's 2023 Fierce 15 See omnystudio.com/listener for privacy information.

Life sciences organizations are facing both intense pressure and extraordinary opportunity, according to Mark Sullivan, president of regulated industries at Salesforce. In a conversation with The Top Line’s Chris Hayden, Sullivan said companies too often operate in “survival mode,” focused on defending margins rather than leading innovation. But with the rise of AI and agentic technologies, he said, the industry is poised for a transformation that could reshape how drugs are developed, trials conducted and patient data used — all at greater speed and lower cost. Sullivan emphasized that this new era requires rethinking how companies engage with stakeholders. Instead of distant, one-way interactions, he said, agentic AI enables dynamic, conversational relationships that improve satisfaction and generate actionable insights. Salesforce, he noted, is expanding beyond its CRM roots to help life science enterprises become “agentic” organizations — integrating secure, compliant AI systems across finance, HR and supply chains. With data security and trust at the core, Sullivan called on leaders to look beyond software replacement and pursue true digital transformation for the good of patients and the industry alike.See omnystudio.com/listener for privacy information.

The FDA made waves in early September when it announced a plan to publicly release complete response letters (CRLs) at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency.” At the same time, the FDA released 89 new CRLs, adding to the more than 200 that were previously made public in July and shedding more light on the agency’s often opaque review process. That earlier document dump, though, only included rejection letters for drugs that were eventually approved. Now, for the first time, the agency is releasing CRLs for unapproved drug candidates—including recent high-profile rejections such as Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug. Publicly airing the rationale for rejecting drug candidates is a significant shift for the FDA and a potential cause for concern for the biopharma industry. To unpack what the new policy means for drug developers, Fierce Biotech’s Darren Incorvaia sat down with Torrey Cope, a lawyer with Sidley Austin who represents and advises life sciences companies on issues related to the FDA. To learn more about the topics in this episode: FDA releases ‘initial batch’ of more than 200 drug rejection letters FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub FDA misinterpreted efficacy data that prompted DMD rejection, Capricor claims ‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process 'Several concerning observations': FDA sheds more light on reasons it rejected drugs See omnystudio.com/listener for privacy information.

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.

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. See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.

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.See omnystudio.com/listener for privacy information.

In the latest episode of The Top Line podcast, host Heath Clendenning interviews Cheryl Lubbert, CEO of Reverba Global, to discuss how science-led storytelling is reshaping communications in the pharmaceutical industry. Lubbert, a veteran executive with experience at Amgen, Abbott and Bristol Myers Squibb, says authenticity, empathy and transparency are now critical to rebuilding public trust. She argues that scientific data, when paired with real patient and caregiver stories, becomes more impactful—helping both healthcare providers and patients better understand and engage with treatments. Lubbert also highlights the growing importance of breaking down silos between marketing and medical affairs. By integrating these functions, she says pharma companies can provide more consistent, credible messaging and support shared decision-making in clinical settings. With real-world examples—from peer mentorship programs to immersive educational initiatives—Lubbert makes a compelling case for treating storytelling as a strategic tool, not just a creative one. For more on how these approaches are driving better outcomes, listen to the full episode of The Top Line.See omnystudio.com/listener for privacy information.

Despite the long holiday weekend, news in biopharma never slows down. In this week’s episode of "The Top Line," the Fierce team breaks down some of the biggest stories from the past week. On the pharma side, Eric Sagonowsky and Kevin Dunleavy examine Big Pharma’s first-quarter 2025 performance. While most of the top 25 companies are still delivering strong sales growth despite emerging uncertainties in Washington, D.C., a few major players are starting to see a slowdown. Each company tells a different story, and Sagonowsky and Dunleavy dive into the nuances of the current commercial landscape. Later, Fierce Biotech's Gabrielle Masson and Darren Incorvaia highlight key data from the American Society of Gene & Cell Therapy conference and preview what the team is watching at this week’s American Society of Clinical Oncology annual meeting. To learn more about the topics in this episode: Seven top pharmas posted revenue declines in Q1. The common thread? All are US firms Atsena eye disease gene therapy hits safety goals, closes retinal splits in phase 1/2 ASGCT: Analysts see Rocket gene therapy setting 'a new bar' for efficacy in heart condition Rocket crashes as gene therapy patient dies, FDA imposes hold This episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

President Donald Trump put the pharmaceutical industry on notice early Monday with the signing of his "most favored nation" (MFN) executive order on drug prices. The order seeks to tie U.S. prices to significantly lower costs overseas. Many questions remain about how the measure will be implemented, and legal challenges are almost certain. To assess the seriousness of the threat, Fierce Pharma assembled a team of reporters and editors to break down the executive order and the industry’s response. After examining the MFN executive order, the group dives into other recent policy developments in Washington, D.C., and beyond, including tariffs, Medicare drug price negotiations and more. To learn more about the topics in this episode: Trump signs sweeping executive order to cut US drug prices by 'up to 90%' Sanofi, Novartis CEOs lambast EU price control as Trump reportedly weighs drug cost parity with other nations As Trump threatens tariffs on drugs, industry warns EU of $100B-plus pharma exodus to US US net drug spending surged 11.4% last year, boosted by obesity and oncology meds: IQVIA This episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

Angela Hwang spent nearly three decades at Pfizer before joining Flagship Pioneering in 2025 as a CEO-partner and the CEO of Metaphore Biotechnologies. In this week’s episode of "The Top Line," the former Pfizer chief commercial officer speaks with Fierce Pharma Deputy Editor Angus Liu about her transition from marketing drugs at a Big Pharma company to advancing novel technology at a young biotech startup. Hwang discusses how her upbringing in apartheid-era South Africa—and two key lessons from her career—shaped who she is today. A longtime champion of diverse talent, she emphasizes that regardless of the broader environment or the size of an organization, it’s essential to ensure “everybody has a chance of developing in their careers and that they have a level playing field.” To learn more about the topics in this episode: 'We have not seen anything similar': Novo Nordisk pens $600M obesity pact with Flagship's Metaphore 2022's Fiercest Women in Life Sciences—Angela Hwang Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline See omnystudio.com/listener for privacy information.

Although East Asians make up a significant share of entry-level roles in U.S. biopharma, few have risen to senior leadership positions. That disparity is what inspired the launch of ElevAAte—a new nonprofit founded this year to support and grow East Asian American leadership in the industry. In this week’s episode of "The Top Line," Fierce Pharma Deputy Editor Angus Liu speaks with two of ElevAAte’s co-founders: Architect Therapeutics CEO Angie You and Candid Therapeutics CEO Ken Song. The veteran biotech leaders discuss why a group like ElevAAte is needed and how East Asian Americans can harness their collective strength to build the next generation of biopharma executives. You and Song—who led Amunix’s $1.2 billion sale to Sanofi and RayzeBio’s $4.1 billion acquisition by Bristol Myers Squibb, respectively—also share insights from their dealmaking careers and offer advice for young professionals entering the field. To learn more about the topics in this episode: Though prevalent in the lab and middle management, East Asian Americans are underrepresented in biopharma C-suites: report Candid's T-cell engager shopping spree rolls on with WuXi Biologics pact worth up to $925M A reason to fight: Former FDA leader Janet Woodcock inspires 3rd Biotech Sisterhood summit Takeda taps Julie Kim to take over for retiring CEO Christophe Weber This episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

We’ve known for a while that there are two Anguses—both journalists covering oncology at health- and biopharma-focused news outlets. Now, for the first time, we’re bringing them together for a “Variety Studio: Actors on Actors”-style conversation. In this week’s episode of "The Top Line," Fierce Pharma Deputy Editor Angus Liu and STAT Cancer Reporter Angus Chen share insights into their work covering cancer and their thoughts on racial identity during a tumultuous time. They discuss what excites them most in the oncology field, how their reporting approaches differ and how they’ve often been mistaken for one another. To learn more about the topics in this episode: Judge permanently blocks NIH grant caps, prompting HHS appeal Cancer research, long protected, feels ‘devastating’ effects under Trump As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty CAR-T cells can arm other immune cells with engineered proteins to fight cancer, study says See omnystudio.com/listener for privacy information.

After a batch of much-anticipated reciprocal tariffs spared pharmaceuticals in early April, drugmakers, medtech companies, manufacturers and other outfits across the life sciences spectrum are still scrambling to respond to mounting trade pressures. While many unknowns remain, biopharma companies should waste no time in starting to evaluate their options. In this week’s episode of “The Top Line,” we dig into the latest round of tariffs unveiled by the Trump administration and how they could impact multiple areas of the life sciences industry. Fierce Pharma’s Fraiser Kansteiner sits down with KPMG’s life sciences sector leader Kristin Pothier, who discusses how the current tariffs could pose challenges, how drugmakers and other life sciences companies should respond and whether additional sector-specific duties are on the horizon. To learn more about the topics in this episode: As Trump's 'Liberation Day' tariffs seem to spare pharmaceuticals, threat of industry-specific duties and loopholes persists Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO survey Eli Lilly CEO on Trump's tariffs: 'It'll be hard to come back from here' Trump again threatens tariffs on pharmaceuticals in 'not too distant' future This episode is sponsored by Cencora.See omnystudio.com/listener for privacy information.

In this week’s episode of "The Top Line," Fierce Deputy Editor Andrea Park and Fierce Biotech Senior Editor Gabrielle Masson discuss how workforce reductions impacted the biopharma industry in the first quarter. The pair examine industry trends, company closures, developments in the cell and gene space—and the reductions in force happening at federal health agencies alongside them. To learn more about the topics in this episode: Biopharmas laid off staffers at least 63 times in Q1: Fierce Biotech analysis Fierce Biotech Layoff Tracker 2025: Pfizer sells site, cuts staff; Opthea reduces workforce by 65% See omnystudio.com/listener for privacy information.

In this week’s episode of "The Top Line," Fierce Biotech’s Gabrielle Masson and Darren Incorvaia sit down to discuss a recent special report from Fierce Biotech, ranking the top 10 R&D budgets from 2024. Did Merck hold on to its 2023 crown? And did any new faces crack this year’s list? Listen to find out! To learn more about the topics in this episode: The top 10 pharma R&D budgets for 2024 This week's episode is brought to you by Cencora.See omnystudio.com/listener for privacy information.

Since the first days of the new Trump administration, the White House has handed down orders to ban work focused on diversity, equity and inclusion (DEI) across the federal government. Some in the private sector—both inside and outside of healthcare—have followed the same path, eliminating DEI officer positions and ending initiatives that in some cases have been tied to millions of dollars in research funding. What does the field—and, ultimately, the patient—stand to lose from this effort? In this week’s episode of The Top Line, we hear from Nada Hanafi, co-founder of MedTech Color, a professional network aimed at building and supporting diverse leadership in the industry. Hanafi joins Fierce Medtech’s Conor Hale to discuss how studying diversity in a healthcare context has become integral to developing new medical breakthroughs and realizing the promise of precision medicine. To learn more about the topics in this episode: FDA issues draft guidance on ensuring pulse oximeter accuracy across skin tones How Trump's DEI executive orders could impact healthcare After White House transition, FDA’s diversity guidance for clinical trials no longer available As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials Amid Trump's push to abolish DEI, Roche and Novartis adjust hiring initiatives: reports See omnystudio.com/listener for privacy information.

In this episode of The Top Line, sponsored by PatientPoint, Andrew Schultz, President of PatientPoint Precision, discusses how hypertargeting and contextual relevance are redefining patient marketing. Traditional direct-to-consumer (DTC) campaigns often rely on educated guesses, but PatientPoint Precision blends EHR data and patient context to deliver hyper-personalized, high-impact messages. By engaging patients at critical touchpoints—like logging into a portal or checking in for an appointment—marketers can deliver tailored, valuable content that enhances patient experiences and drives better health outcomes. Schultz emphasizes the importance of trust, consent, and privacy in utilizing this treasure trove of data securely. With PatientPoint Precision’s ability to integrate data and context, brands can now create robust, personalized campaigns that truly resonate with their target audiences. Listen to the full episode to learn how this new DTC approach is transforming patient engagement.See omnystudio.com/listener for privacy information.

Johnson & Johnson’s Stelara, Regeneron’s Eylea and Amgen’s Prolia are just some of the drugs facing off against new biosimilars or generics in 2025, as featured in the latest edition of Fierce Pharma’s annual special report documenting the 10 biggest losses of U.S. exclusivity expected throughout the year. In this week’s episode of The Top Line, we dig into the report, which details the stories behind 10 key medicines that are set to face off against new generic or biosimilar competitors this year as their patents expire. Fierce’s Eric Sagonowsky and Angus Liu recap the report, sharing their perspectives on several of the drugs and discussing the industry effects of 2025’s sizable patent cliff. To learn more about the topics in this episode: The top 10 drugs losing US exclusivity in 2025 After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara Amgen grabs FDA thumbs-up for Soliris biosim, eyes 2025 launch Novartis wins 11th-hour bid to block generic version of blockbuster heart med Entresto Amgen settles Prolia patent suit with Celltrion, teeing up potential biosimilar launch in June See omnystudio.com/listener for privacy information.

Agenus Chief Medical Officer Dr. Steven O'Day joined Fierce's Chris Hayden on a recent sponsored episode of The Top Line podcast to discuss the evolving landscape of cancer immunotherapy. O'Day, a medical oncologist with 30 years of experience, explained the fundamental differences between immunotherapy and traditional cancer treatments like chemotherapy, surgery, and radiation. He emphasized immunotherapy's potential for durable responses and even cures by activating the body's own T-cells to fight cancer. The conversation addressed the challenges of treating "cold" tumors, such as colorectal cancer, which are less visible to the immune system. O'Day highlighted Agenus's pipeline of antibodies, botensilimab (BOT) and balstilimab (BAL), designed to trigger T-cell recognition of these colder cancers. O'Day expressed his excitement about a potential "2.0 revolution" of immuno-oncology, expanding the benefits of immunotherapy to a wider range of cancers. He described BOT and BAL as a "one-two punch," with BOT priming T-cells and BAL preventing their exhaustion. Listen to the full conversation on the latest episode of The Top Line.See omnystudio.com/listener for privacy information.

Despite a rocky start for many drugmakers at the start of last year, 2024’s fourth quarter saw just two of the top 25 global pharma companies record sales declines. But that growth may be short-lived, as many of those same companies forecast more muted revenue increases in 2025. In this week’s episode of The Top Line, we dissect the unprecedented revenue growth enjoyed by many of the world’s top pharma companies by sales in the fourth quarter of last year. Fierce Pharma’s Kevin Dunleavy and Fraiser Kansteiner discuss the period’s results, examine the companies’ performance expectations going into 2025 and consider whether the momentum seen in Q4 is repeatable or more of an anomaly. To learn more about the topics in this episode: Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4 Eli Lilly logs massive Q4 revenue jump—but it's not just thanks to Mounjaro and Zepbound Pfizer harnesses COVID fluctuations to clinch Q4 gains as RSV vaccine sales plummet Astellas takes $760M charge, reveals slowdown for eye drug Izervay after regulatory stumbles This episode is brought to you by Cencora.See omnystudio.com/listener for privacy information.

In the latest episode of The Top Line, Chris Hayden of Fierce Pharma sits down with Mary Lou Glotzbach, senior manager of drug delivery partnerships at Grand River Aseptic Manufacturing (GRAM). They explore the evolving landscape of biologics, the increasing importance of cold chain management, and how contract development and manufacturing organizations (CDMOs) are adapting to industry shifts. Glotzbach highlights a growing trend in biotech: transitioning patient treatments from infusion centers to home delivery. This shift demands innovative drug delivery solutions, including wearable devices and auto-injectors, capable of handling high-viscosity biologics. She also emphasizes the industry's push for smaller batch sizes due to the high cost and complexity of producing biologics, which challenges traditional manufacturing processes. Another key discussion point is the rising demand for transparency and early collaboration between pharmaceutical companies, CDMOs, and device manufacturers. Glotzbach notes that CDMOs are now being brought into the development process earlier than ever, allowing for better alignment on formulation, container design, and regulatory compliance. The conversation also touches on Annex 1 compliance and the need for standardization in primary containers like syringes and cartridges. Glotzbach envisions a future where standardized components streamline production, making drug development more efficient. For anyone interested in the intersection of biologics, manufacturing, and drug delivery innovation, this episode offers valuable insights into how GRAM is helping shape the future of the industry. Tune in to learn more about the latest advancements and challenges in aseptic manufacturing.See omnystudio.com/listener for privacy information.

The latest episode of The Top Line, sponsored by ViiV Healthcare, features Dr. Luis Buzón, an infectious disease specialist, discussing the critical role of real-world evidence in HIV treatment and prevention. While clinical trials establish the safety and efficacy of new therapies, real-world data help bridge the gap between these highly controlled environments and patient care in the real world. Buzón explains that collecting long-term data is essential, especially for lifelong conditions like HIV. Not only do real-world studies track how medicines perform over longer periods of time than clinical trials, they include a broader range of people, revealing potential side effects not seen in trials and ensuring long-term effectiveness for the different people who can be impacted by HIV. Beyond the science, Buzón shares how his father was a pioneer in Spain’s early response to the HIV epidemic, and why, inspired by his father’s dedication, he continues to advocate for compassionate, evidence-based care. For those interested in the evolving landscape of HIV treatment and prevention and the power of real-world data in shaping better health outcomes, this episode is a must-listen. Tune in to The Top Line to hear Buzón’s expert insights and personal perspective.See omnystudio.com/listener for privacy information.

For the biotech industry, 2024 meant the return of the venture capital megaround. And one startup, Xaira Therapeutics, took it a step further, expanding the industry’s definition of a megaround by reeling in a rarely seen $1 billion financing early in the year. In this week’s episode of The Top Line, we dive into a recently published report from Fierce Biotech highlighting the industry’s top 10 money raisers in 2024, led by none other than Xaira. Fierce’s Gabrielle Masson and Andrea Park talk about some of the year’s biggest financing rounds, how 2024’s list compares to 2023 and what indications are changing the fundraising scene. To learn more about the topics in this episode:   Biotech's top money raisers of 2024 Fierce Biotech Fundraising Tracker '24 Biotech's top money raisers of 2023 See omnystudio.com/listener for privacy information.

Huntington’s disease was long thought to be caused by the slow buildup of a toxic protein, but new research has revealed that it’s actually driven by the expansion of a gene that, at a certain length, triggers quick neuron death. In this week’s episode of The Top Line, we hear from Steven McCarroll, Ph.D., a Huntington’s disease researcher at the Broad Institute of MIT and Harvard, whose team recently published that research in the journal Cell. McCarroll joins Fierce Biotech’s Darren Incorvaia to dig into the findings, which not only change our understanding of the disease itself, but also open up new avenues for potential treatments. To learn more about the topics in this episode: New findings shed light on cause of Huntington's disease progression Scientists look to survival secrets of plants for Huntington's treatments Scientists use long-approved GSK HIV drug to stave off dementia, Huntington's proteins in mice Sage drops dalzanemdor as Huntington's failure completes clean sweep of midphase flops See omnystudio.com/listener for privacy information.

Clinical-stage drug development offers big rewards—and big risks. To that end, Fierce Biotech recently published its annual roundup of several of the most eye-catching trial failures of the preceding year. The 2024 list includes trial flops from the likes of AbbVie, Novo Nordisk, Pfizer and more, with reports of disappointing results in many tough-to-treat indications, including schizophrenia and Alzheimer's disease. In this week’s episode of The Top Line, we dive into the report. Fierce Biotech’s James Waldron and Gabrielle Masson discuss the entries that stood out for them and ask what lessons the biopharma industry can learn from these setbacks going forward. To learn more about the topics in this episode: 2024's top 10 clinical trial flops AbbVie's $9B schizophrenia prospect flunks phase 2 trials, handing advantage to BMS GSK surrenders HSV vaccine hopes after phase 2 fail, ceding race to Moderna, BioNTech Merck halts phase 3 TIGIT trial after immune-mediated adverse events prompt discontinuations Pfizer's phase 3 gene therapy trial fails to improve function for boys with Duchenne muscular dystrophy See omnystudio.com/listener for privacy information.