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The Top Line

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.

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August 14 · 23 min
A genomics library for the AI era
Having spent 14 years building out its capacity, Regeneron Genetics Center—the genomic research branch of the Tarrytown, New York-based pharma—is a pro when it comes to the sort of target validation work central to the field today. Now, as RGC continues the massive expansion of its genetic database, the center’s unique ability to interpret that trove of data could give it an edge in the age of AI-powered drug development. In this week’s episode of "The Top Line," Fierce’s Fraiser Kansteiner sits down with Andy Deubler, chief business and administrative officer at Regeneron Genetics Center, to discuss the role RGC plays in the larger Regeneron model, as well as where the center could be headed as drug development pushes into new technological frontiers. Aside from the data interpretation advantage RGC believes it holds in the AI era, Deubler also discusses how the unit’s ongoing genetic research has helped deliver recent breakthroughs like the hearing loss gene therapy Otarmeni. To learn more about the topics in this episode: Regeneron ushers in new genetic medicine era with groundbreaking gene therapy approval J. Craig Venter launches genomics startup designed to boost diagnostic insights Genomics inks partnership deal with Greywolf to assess gene datasets How a new tool for large-scale gene editing could power novel genetic medicines In global life sciences, insight isn’t the problem—execution is. Disconnected dashboards, siloed teams and fragmented workflows make it harder to act—consistently, compliantly and at scale. ZAIDYN by ZS closes that gap. ZAIDYN is the Life Sciences Intelligence Platform that embeds intelligence in the flow of work, based on domain expertise and agentic AI across commercial, medical, patient and content work. Trusted by more than 150 life sciences organizations across over 100 countries, ZAIDYN is built for global scale, regulatory compliance and trusted AI—so teams act together across brands, markets and channels. ZAIDYN. Move beyond reporting to intelligent action. Learn more at ZAIDYN.ai See omnystudio.com/listener for privacy information.
August 10 · 26 min
The next frontier in patient support: Connected data, AI and personalized engagement (Sponsored)
The future of patient support may depend less on how much data organizations collect and more on how effectively they connect, govern and activate it. In this sponsored episode of The Top Line, host Stephanie Butler speaks with ZS principals Asheesh Shukla and Kirti Prakash about the changing role of patient data in life sciences and what it will take to support more personalized engagement at scale. The conversation examines several shifts reshaping the industry, including the move from reactive care to proactive intervention, the growing role of AI-powered experiences and the increasing importance of trust, consent and compliance in patient engagement. As organizations invest in new technologies, the speakers contend that success will depend on creating connected data foundations that can deliver timely, actionable insights across the patient journey. Listeners will hear practical guidance on structuring data for actionability, building AI-ready capabilities and designing governance models that support both innovation and accountability. The discussion closes with a look at where patient services may be headed next and why organizations that prepare now will be better positioned to improve patient experiences and outcomes in the years ahead. See omnystudio.com/listener for privacy information.
August 7 · 20 min
Novo Nordisk’s CFO on the oral Wegovy rollout and beyond
Novo Nordisk’s second-quarter earnings results this week were closely watched by analysts and investors eager to see whether the rollout of oral Wegovy could neutralize concerns about the pharma’s pipeline. Fierce spoke to Novo’s chief financial officer, Karsten Munk Knudsen, to dig into the figures, including the reasons behind the company’s decision to raise its full-year guidance and the launch of oral Wegovy across Europe. In the candid conversation, Knudsen also reflected on Novo’s “rollercoaster” journey in obesity, his approach to pursuing long-term growth for the company and why he’s “still optimistic” about CagriSema despite recent setbacks. To learn more about the topics in this episode: Novo CEO accepts ‘couple of setbacks’ in R&D as CagriSema posts more mixed data Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO See omnystudio.com/listener for privacy information.
August 3 · 15 min
Inside Noble’s connected approach to patient support (Sponsored)
The continued shift toward self-administered therapies is changing how pharmaceutical companies think about patient support. While access and affordability remain priorities, a growing share of industry attention is focused on the patient experience itself, particularly during the critical transition from prescription to successful treatment initiation. In this episode of The Top Line, Adam Shain, Vice President and Head of Business Transformation and Growth and Government Affairs Lead at Noble, an Aptar Pharma company, examines why patient onboarding, device training, and engagement strategies are increasingly being viewed as interconnected components of a broader patient experience. Drawing from Noble's work in self-administration support, Shain discusses the importance of incorporating patient insights into program design, the evolving complexity of at-home treatment models, and the industry's growing focus on adherence and long-term treatment success. See omnystudio.com/listener for privacy information.
July 31 · 25 min
Psychedelics, peptides and GLP-1s
Is 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.
July 24 · 11 min
GSK’s first lung cancer approval, a new IPO path and more
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.
July 20 · 17 min
Why modern clinical trials need a finance-first strategy (Sponsored)
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.
July 17 · 24 min
5 emerging biotech hubs
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.
July 14 · 22 min
Operating at the speed of science: The new medical affairs playbook (Sponsored)
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.
July 13 · 18 min
Decision readiness is the next AI advantage (Sponsored)
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.
July 10 · 24 min
A $10B deal, China trial scrutiny and highlights from ADA 2026
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.
June 26 · 41 min
The deal before the deal
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.
June 22 · 20 min
FDA Breakthrough Therapy and RMAT: Strategic Decisions That Can Accelerate Oncology Development (Sponsored)
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.
June 12 · 15 min
Ipsen R&D chief on pipeline discipline, partnerships and 2026 milestones
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.
June 10 · 18 min
Why MRD is becoming central to oncology drug development (Sponsored)
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.
June 5 · 29 min
Behind the headlines of ASCO 2026
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.
June 3 · 21 min
Mesutoclax points to possible shift in high-risk MDS and AML (Sponsored)
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.
May 29 · 35 min
Boston, China and the future of biotech
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.
May 28 · 9 min
Why direct-to-patient is the future of pharma access (Sponsored)
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.
May 22 · 12 min
BioAge CEO talks NLRP3 and ‘pipeline in a pill’ ambitions
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.

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