Published by Fierce Life Sciences
Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning.
Listen on Apple PodcastsIs biotech taking a trip to the world of psychedelic drugs? Why is Novo Nordisk going after Eli Lilly’s Zepbound ads? And what are peptides? This week on "The Top Line," Fierce's Zoey Becker, Will Maddox and Kevin Dunleavy chat about some of the biggest recent stories. From a psychedelics acquisition that could spark more movement in the emerging field to an advisory committee meeting on peptides shrouded in political controversy to a lawsuit between the two major obesity drugmakers, we’ll catch you up on the latest developments shaking up the biopharma world. To learn more about the topics in this episode: ‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics UPDATE: Peptides favored on 1st day of closely watched FDA compounding adcomm Peptide adcomm Day 2: Emideltide voted down in panel's 1st pushback Novo Nordisk files lawsuit accusing rival Eli Lilly of running ‘false and misleading’ GLP-1 ads Novo escalates Lilly false advertising suit with planned bid to halt comparative ads See omnystudio.com/listener for privacy information.
This week on "The Top Line," Fierce Healthcare and Life Sciences' editor-in-chief steps behind the microphone for a solo episode highlighting several of the biggest stories in biopharma. The episode covers GSK’s first lung cancer approval following its acquisition of Nuvalent, Axiom Biosciences’ unusual plan to list first in Hong Kong before pursuing a Nasdaq co-listing amid a resurgent biotech IPO market, and the U.S. House’s passage of legislation directing the FDA to update its animal testing rules. The episode also includes an update from the Fierce newsroom, including the arrival of a new Fierce Biotech staff writer, and a reflection on why human judgment, curiosity and original reporting matter more than ever. To learn more about the topics in this episode: GSK secures first lung cancer approval as FDA clears Jideytro in quick payoff from Nuvalent deal ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong House passes bill directing FDA to update animal testing rules See omnystudio.com/listener for privacy information.
Clinical trial success depends on more than scientific rigor and operational execution. It also depends on the financial systems that support every stage of a study. In this episode of The Top Line , Zahiah “Zee Zee” Gueddar, senior director of commercial strategy for the Clinical Trial Financial Suite at IQVIA Technologies, discusses why modernizing clinical trial finance has become a strategic priority for sponsors. As trials become more complex, fragmented systems and manual workflows are creating bottlenecks that limit visibility, delay payments and introduce unnecessary risk. Gueddar explains how these challenges affect site relationships, operational efficiency and study performance, and why organizations can no longer afford to treat finance as a disconnected administrative process. The conversation also highlights key indicators of readiness for transformation, from cross-functional alignment to executive sponsorship, and outlines the common pain points study teams face today. Ultimately, success depends on moving toward a connected, transparent and predictable financial model that reduces friction, improves collaboration and supports faster, more reliable clinical trials. See omnystudio.com/listener for privacy information.
Boston. San Francisco. Beijing? The global biotech industry has long been concentrated in a handful of cities. But which emerging hubs could become dominant forces in biotech in the decades ahead? In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia and Will Maddox discuss a new Fierce special report identifying five cities with the potential to become major forces in the global biotech industry. Did your favorite city make the cut? Listen to find out. To learn more about the topics in this episode: Top emerging biotech hubs in 2026 As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’ British biotech VC funding shows ‘signs of recovery,’ but IPO rebound yet to materialize Could Basel be the next Boston? How the Swiss biotech hub is quietly raising its game This week's episode is sponsored by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com See omnystudio.com/listener for privacy information.
Medical affairs is at an inflection point. As science advances and healthcare professionals gain access to information in real time, medical teams face a mandate to deliver insight with greater speed, relevance and impact. In this episode of The Top Line , Josh Schwartz, Vice President of Medical Affairs, North America at BeOne Medicines , and Jalpa Shah, who leads the medical and evidence practice at ZS Pharma discuss what a modern medical affairs model requires. The conversation explores how the function is becoming a more strategic business driver and why traditional measures of activity are no longer enough to demonstrate value. The episode examines the structural challenges that continue to hold organizations back, including fragmented data systems, limited visibility into insights and the difficulty of translating engagement into measurable outcomes. It also looks at how artificial intelligence (AI) is reshaping workflows by helping teams generate insights faster, identify trends and inform next best actions. The discussion also considers the capabilities, operating models and cultural shifts medical affairs teams will need to keep pace with science and influence clinical practice. The central takeaway is clear: Future success will depend less on access to more data and more on the ability to turn intelligence into coordinated action. See omnystudio.com/listener for privacy information.
AI is reshaping how organizations compete, but more data and more tools do not automatically lead to better decisions. In this episode of The Top Line , Justin Masterson, senior vice president of human sciences at The Directions Group, challenges leaders to look beyond AI adoption and focus on the discipline required to act on intelligence. Masterson argues that the defining issue for many organizations is not a data problem, but a decision readiness problem. As information ecosystems become more complex, the ability to translate insight into timely, confident action is emerging as a critical business differentiator. With more than 20 years of experience in healthcare and human sciences, Masterson shares perspective on how companies can align teams, processes and strategies to unlock AI’s value without becoming overwhelmed by the volume of available information. For leaders navigating new technologies, competing priorities and higher expectations for speed, this conversation offers a practical reframing of where AI value is created. Learn why decision readiness may be the next true advantage. See omnystudio.com/listener for privacy information.
This week on "The Top Line," we’re covering some of the biggest stories across biopharma before turning to one of the industry’s major scientific meetings of the summer. First, we discuss Vertex’s $10 billion acquisition of Crinetics Pharmaceuticals, the company’s largest deal to date, and what it says about Vertex’s push beyond its historic strength in cystic fibrosis. We also cover growing scrutiny from U.S. lawmakers over the industry’s use of clinical trials in China. Then, Fierce Pharma Senior Editor Fraiser Kansteiner recounts his recent trip to New Orleans for the American Diabetes Association’s 2026 Scientific Sessions with Fierce Pharma Marketing’s Zoey Becker. For years, ADA has focused heavily on its eponymous indication, but this year’s meeting made clear how much the conversation is evolving, with obesity data from drugmakers of all stripes taking up more of the spotlight. Topics include the biggest data sets from the meeting, what it was like to sit down with Novo Nordisk’s new CEO for the first time and the latest from Insulet’s Marvel collaboration on a line of comics about an Omnipod-wearing superheroine. To learn more about the topics in this episode: Vertex, in its largest-ever deal, acquires endocrine disease specialist Crinetics for $10B As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’ ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO ADA: Lilly pulls back curtain on impressive triple-G efficacy in patients with obesity, diabetes ADA: Amgen highlights Repatha perks, GLP-1 pitfalls in push to boost cardiometabolic pedigree With ADA in the books, analyst says Lilly is ‘widening its lead’ in the obesity race ADA: Novo's Wegovy pill reaches new GLP-1 patients with impressive 3M prescription milestone ADA: Tolerability ‘not to be underappreciated’ in Roche, Zealand’s amylin obesity prospect ADA: Boehringer execs claim survodutide tolerability 'consistent' with class despite phase 3 update ADA: Lilly posts oral semaglutide-topping data as Foundayo speeds toward 2nd potential nod in diabetes This week's episode is sponsored by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com See omnystudio.com/listener for privacy information.
Big Pharma dealmaking has picked up, but the biotech path to a signed agreement is still anything but simple. In this episode, recorded at Fierce Biotech Week, Senior Editor James Waldron leads a discussion on the evolving BD&L landscape across pharma and biotech. He is joined by Kaleem Chowdhury, Ph.D., CEO of Haiku Biosciences; Liz Leveille, who leads the Boston Innovation Hub and discovery transactions at Merck; and Abbas Kazemi, CEO of Nimbus Therapeutics. The panel digs into the realities behind the headlines, from investor scrutiny and platform company pressure to China’s growing role in licensing and the long relationship-building that often happens before a deal gets done. To learn more about the topics in this episode: March M&A surge triggers high expectations for 2026 'Biopharma ecosystem is back to full health,' fueled by M&A: PwC Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep up After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst Was Big Pharma’s ‘unusually aggressive’ M&A spree to blame for March IPO drought? This week's episode is sponsored by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com See omnystudio.com/listener for privacy information.
In this sponsored episode of The Top Line, host Stephanie Butler is joined by Sheila Plant, vice president of regulatory affairs at Allucent, to examine how FDA Breakthrough Therapy and RMAT designations can support more strategic oncology development. Although both pathways are intended to speed development, they are not interchangeable. Plant outlines the key distinctions, noting that Breakthrough Therapy requires evidence of substantial improvement over existing treatments, while RMAT is available for regenerative medicine therapies and centers on preliminary clinical evidence indicating the potential to address unmet medical needs. The conversation also explores the strategic choices that determine whether sponsors are ready to pursue these designations, from building a credible data package to designing trials with clinically meaningful endpoints and keeping manufacturing readiness aligned with development timelines. Once a designation is granted, closer collaboration with the FDA can help sponsors navigate development with more dynamic feedback. But as Plant emphasizes, these pathways deliver the greatest value when they are part of a disciplined regulatory strategy. Listen now to learn how sponsors can approach expedited pathways with greater clarity and position oncology programs for meaningful acceleration. See omnystudio.com/listener for privacy information.
In this episode of “The Top Line,” recorded on site at Fierce Biotech Week in Boston, Fierce’s Ayla Ellison sits down with Christelle Huguet, Ph.D., executive vice president and head of R&D at Ipsen, to discuss how the company is building its pipeline through external innovation while maintaining internal scientific accountability. Huguet explains Ipsen’s approach to partnering, describing the company as an “accelerator” that helps move promising science from academic labs and biotech partners toward patients. She also discusses how Ipsen evaluates which programs move forward, why transparency with partners is essential from the start and what the company is watching as it heads into a year with several key clinical and regulatory milestones. To learn more about the topics in this episode: Ipsen unveils data for Botox rival that drove long-acting anti-wrinkle jab into phase 3 Ipsen scuttles liver disease candidates from $952M Albireo acquisition This week's episode is sponsored by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com See omnystudio.com/listener for privacy information.
In this sponsored episode of The Top Line , experts from Myriad Genetics join host Stephanie Butler to examine how tumor-informed molecular residual disease, or MRD, testing is beginning to redefine what early insight can mean in oncology drug development. As biomarker-driven therapies become more precise, the ability to understand response earlier and more clearly is increasingly being viewed as foundational to smarter development strategy. The discussion looks at how ultrasensitive, tumor-informed MRD assays can help track response over time, potentially surface deeper signals earlier and inform decisions that shape trial design, patient selection and regulatory direction. It also considers why these capabilities may become more important as oncology programs face growing pressure to balance speed, flexibility and evidence generation. Listeners will hear why early diagnostic strategy is increasingly seen as a competitive differentiator, how MRD can help teams make better decisions sooner and why its role in oncology development is expected to continue to evolve and expand. See omnystudio.com/listener for privacy information.
Each year, the global oncology community flocks to Chicago to convene at the American Society of Clinical Oncology’s annual meeting for a weekend of buzzy data drops, practice-changing posters and insightful sessions. In this week’s episode of "The Top Line," Fierce Biotech and Fierce Pharma’s Darren Incorvaia, Zoey Becker and Angus Liu break down the biggest takeaways from their weekend of reporting live from the Windy City. From “nutty” in vivo CAR-T data to a historic first for a Chinese biotech asset, ASCO 2026 reflected new and continuing trends within the evolving state of cancer care today. To learn more about the topics in this episode: ASCO: Revolution Medicines confident in RAS leadership as rivals square up ASCO: Lilly exec points to ‘nutty’ 100% response rate for in vivo CAR-T as justifying Kelonia buyout ASCO preview: With expectations jacked up, Akeso's ivonescimab to face scrutiny in high-stakes plenary This week's episode is sponsored by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com See omnystudio.com/listener for privacy information.
High‑risk MDS and AML continue to challenge clinicians, with limited durable responses and few options for older or treatment‑refractory patients. In this sponsored episode of The Top Line, host Stephanie Butler is joined by Dr. Amer Zeidan, Professor of Internal Medicine at Yale School of Medicine, to unpack new ASCO 2026 data that are drawing attention across the myeloid malignancies field. The discussion focuses on mesutoclax, a novel oral BCL‑2 inhibitor evaluated in combination with azacitidine. Dr. Zeidan breaks down early findings showing a 100% objective response rate with CR rate of 40% per IWG 2006 criteria and 90% composite complete response with CR in 60% in treatment‑naïve high‑risk MDS, along with strong efficacy and encouraging safety signals in AML, with over 80% composite CR, and with potent activity in TP53 mutant, as well as zero death within 30 or 60 days and rapid cytopenia recovery. Listeners will hear how mesutoclax’s potency, selectivity, and pharmacokinetic profile may overcome key limitations of existing BCL‑2 inhibitors, and what these results could mean for future frontline treatment strategies. See omnystudio.com/listener for privacy information.
Boston remains biotech's most influential hub, but the questions facing the region are increasingly global. Recorded live at Fierce Biotech Week in Boston, this panel discussion brings together Uli Stilz, senior advisor at Flagship Pioneering; Bruce Beutel, CEO and co-founder of PassKey; and Ben Bradford, head of external affairs at MassBio, for a conversation about the future of biotech innovation. Moderated by Senior Writer Darren Incorvaia, the discussion explores everything from funding pressures and talent trends to AI, clinical development and growing competition from biotech ecosystems around the world. Along the way, the panelists debate what the industry can learn from China's rapid innovation model, why investors and pharma companies have shifted toward clinically validated assets and whether biotech needs a fundamentally new operating model to accelerate drug development and bring breakthrough science to patients. To learn more about the topics in this episode: After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep up As calls for COINS Act expansion grow, will new rules sweep up China biotech licensing? From drug development to M&A, Big Pharmas showcase AI’s ‘measurable impact’ See omnystudio.com/listener for privacy information.
Direct-to-patient models are no longer an experiment - they're becoming a critical part of the modern prescription journey. In this sponsored episode of The Top Line , host Kelly Hogan talks with Jeremy Richardson, chief commercial officer at GiftHealth, about how DTP is redefining access, transparency and speed in pharma commercialization. Richardson shares insights from more than a decade in specialty pharmacy and explains where the traditional model breaks down for patients and providers. He addresses common misconceptions about DTP, including the belief that it only works for cash-pay or consumer-driven drugs, and outlines how a single, seamless platform can support medications across therapeutic areas and price points. With experience guiding more than 7 million patients through their prescription journeys, Richardson discusses what manufacturers truly need from a DTP partner, how technology can accelerate time to therapy and why ease and transparency are becoming nonnegotiable expectations. He also looks ahead to where the prescription journey is headed - and what pharma commercial leaders must do now to keep pace. See omnystudio.com/listener for privacy information.
Recorded last week at Fierce Biotech Week in Boston, this episode of “The Top Line” features a conversation with Kristen Fortney, Ph.D., co-founder and CEO of BioAge Labs. In a conversation with Ayla Ellison, editor-in-chief of Fierce Healthcare and Life Sciences, Fortney discusses the company’s decade-long effort to use human aging data to identify drug targets tied to longevity and age-related disease. She also breaks down BioAge’s oral NLRP3 inhibitor, BGE-102, which the company believes could have applications across cardiovascular, ocular and CNS diseases by targeting inflammation linked to aging biology. The conversation also explores why pharma companies are paying closer attention to aging and exercise biology, how GLP-1 drugs are reshaping conversations around prevention and what the future of aging-related medicine could look like. To learn more about the topics in this episode: BioAge CEO has big plans for 'multi-disease impact' of NLRP3 drug across cardio, ocular and CNS Novartis, BioAge take on age-related diseases in $550M pact What can we learn from 2024’s biotech IPOs? See omnystudio.com/listener for privacy information.
Emerging pharma organizations face unique technology challenges as they prepare for launch. Expectations for AI-enabled decision-making continue to rise, even as teams remain small and operate in highly regulated environments. In this sponsored episode of The Top Line, Fierce Biotech host Kelly Hogan speaks with JR Raelin, executive director of analytics and insight at SynOx Therapeutics and Krishna GS, business technology solutions manager at ZS, about how first-launch and emerging companies can design an agentic future-ready technology road map. The conversation examines common pitfalls, including chasing new technology and AI trends before establishing data readiness, underinvesting in integration, and relying on fragmented point solutions. Raelin and Krishna explain why strong data foundations, governance, and interoperability are prerequisites for. and how agentic AI—when built on that foundation—can close the gap between insight and action in real commercial workflows. Listeners will also hear a framework for scaling platforms over time, guidance on what effective implementation looks like in the first 60 to 90 days, and examples of connected workflows across commercial, medical, and patient functions. The episode closes with a compelling case for why the agentic roadmap is the most important strategic asset a first-launch company builds before its second product—and how getting it right converts a single launch into a portfolio intelligence engine. See omnystudio.com/listener for privacy information.
Despite a prolonged period of policy uncertainty in the U.S.—and the ripple effects across the global life sciences and healthcare industries—executives at health companies are still seeing opportunities amid the tumult. In many cases, they’re finding that the resilient business models they built through disruptions like the pandemic have positioned their companies not just to survive, but to thrive in a new normal for the industry. In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner chats with Glenn Hunzinger, PwC’s U.S. health industries leader, about results from the firm’s recent survey on investor sentiment. Focusing on health companies, Hunzinger explains how many innovative drugmakers have managed to capitalize on the shifting environment. Still, he warns that a more uncertain landscape for U.S. innovation and continued tariff pressures on sectors such as medtech could pose challenges down the line. To learn more about the topics in this episode: AstraZeneca CEO's conservative MFN model excludes reference markets from forecast As Johnson & Johnson navigates changing tariff landscape, execs lay out their expectations Trump eyes 100% tariff rate for companies that have not struck MFN deals: Bloomberg See omnystudio.com/listener for privacy information.
After months of mixed messaging from the White House, the pharmaceutical industry has gained more clarity on the second Trump administration’s import tariff policy for drugs. While many of the industry’s biggest firms have navigated the trade threat through investment pledges and drug pricing deals, the current landscape remains murkier for small- and mid-sized drugmakers. In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner sits down with Chris Young, a principal in KPMG’s trade and customs practice, to discuss the pharma tariff landscape following President Donald Trump’s announcement in early April of a potential 100% tariff on imported drugs. Young explains how the policy could affect smaller drugmakers that haven’t inked high-profile pricing deals with the government and shares best practices for navigating the rapidly evolving U.S. trade environment. To learn more about the topics in this episode: An update on the pharma industry’s reshoring effort Trump eyes 100% tariff rate for companies that have not struck MFN deals: Bloomberg Trump's tariff threats, measured by manufacturing UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract investments See omnystudio.com/listener for privacy information.
In this sponsored episode of The Top Line, host Kelly Hogan speaks with Dr. Bettine Boltres, director of scientific affairs, integrated systems at West Pharmaceutical Services, about the development of the West Synchrony prefillable syringe system. As drug pipelines grow and regulatory expectations increase, pharma and biotech companies face mounting pressure to reduce complexity while accelerating development timelines. Dr. Boltres explains how West Synchrony addresses these challenges by offering a fully integrated system rather than a collection of individual components. By providing complete design verification data, system level specifications and a single global regulatory package, West enables developers to eliminate redundant testing, streamline submissions and move more quickly into clinical fill. The discussion highlights the benefits of single supplier accountability, improved supply security and reduced risk across development and commercialization. Designed for biologics and modern vaccines, West Synchrony sets a new standard in prefillable syringe systems. See omnystudio.com/listener for privacy information.
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