The Top Line

Earnings calls are a chance to catch up with the latest developments across Big Pharma and beyond, and last quarter was no different. From the rollout of AI to the oral GLP-1 battle between Novo Nordisk and Eli Lilly and new leadership at Sarepta and Sanofi, it feels like the opportunities and challenges for biopharma have never been greater. In this week’s episode of "The Top Line," Fierce Pharma Senior Editor Fraiser Kansteiner and Fierce Biotech Senior Editor James Waldron share their takeaways from another whirlwind season of earnings calls. Alongside a Q2 scorecard breakdown, the Fierce editors discuss how several new CEOs are finding their footing, which drugs appear poised to cross the $1 billion sales threshold in 2026 and more. To learn more about the topics in this episode:  Biopharma saw a Q2 sales boom led by Lilly, Sanofi, Regeneron and Astellas  Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow Sarepta’s new CEO Michael Severino faces critical milestones to prove growth See omnystudio.com/listener for privacy information.

Consumerization is changing how patients engage with healthcare, and pharma companies may need to rethink how they approach awareness, diagnosis and commercialization. In this sponsored episode of The Top Line, host Irena Luo is joined by Rachel Stoll, Managing Partner, Growth & Innovation at Princeton10, and Kevin Nalty, Vice President of Strategy at Princeton10, to discuss how evolving patient behaviors are reshaping the healthcare journey. Together, they explore the impact of GLP-1s, telemedicine, AI, wellness technologies and other low-friction healthcare experiences that are raising expectations for convenience and accessibility. The conversation examines emerging gaps between health awareness and clinical diagnosis, the role of wellness tools and health data, and why some patients delay or avoid care altogether. The guests also discuss opportunities for pharma brands to rethink disease awareness, improve navigation to diagnosis and treatment, and borrow engagement strategies from successful consumer platforms that encourage long-term behavior change. Listen to hear practical insights on how brand teams can adapt their commercial strategies, identify hidden friction points and better meet the needs of today's healthcare consumer.See omnystudio.com/listener for privacy information.

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.aiSee omnystudio.com/listener for privacy information.

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.

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.

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.

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.

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.comSee 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.comSee 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.comSee 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.

Theranostics is transforming cancer care, but scaling these treatments requires overcoming operational and workforce challenges. In this episode of The Top Line, Curium’s Mike Patterson discusses how access, safety and trust are shaping the next phase of growth for targeted radiopharmaceutical therapies.   Patterson explains why strong coordination across ordering, manufacturing and distribution is essential to delivering therapies on time. He also explores how building trust with physicians, care teams and patients requires education, consistent communication and reliable support at every stage of the treatment process.   As theranostics expands into community settings, new challenges are emerging. Workforce shortages, training needs and the importance of standardized practices are key considerations for scaling safely. Patterson shares how industry collaboration can help address these gaps while maintaining high standards of care.   He also outlines a future defined by greater access, reduced travel burdens and a more seamless patient experience. Listen to the full episode to learn how Curium is working to make theranostics more accessible across the United States.See omnystudio.com/listener for privacy information.

It’s a pivotal year for RNA therapeutics pioneer Ionis Pharmaceuticals.  After transitioning from a partnering model to a full-ownership strategy following the 2024 approval of Tryngolza, the company is expecting an FDA decision to expand the drug into severe hypertriglyceridemia as its first non-rare-disease indication for a wholly owned product. Meanwhile, potentially game-changing phase 3 readouts are expected from Ionis’ Novartis-partnered lipoprotein(a) candidate and AstraZeneca-partnered ATTR cardiomyopathy program. In this week’s episode of "The Top Line," Fierce’s Angus Liu interviews Ionis CEO Brett Monia, Ph.D. He discusses the science of antisense oligonucleotides, the significance of the two closely watched upcoming clinical readouts, and what it takes to turn a 30-year-old discovery platform into a full-fledged commercial biotech. To learn more about the topics in this episode:  Ionis slashes Tryngolza's price tag by 93% ahead of anticipated label expansion  'It’s going to be huge': The 'diabolical' molecule poised to become biotech's next gold rush  AstraZeneca sets sights on 25+ blockbusters by 2030 to fuel $80B revenue ambition  As questions swirl around ATTR competition, Alnylam plots path to market leadership for Amvuttra  Ionis exec shares method to the Madness after 2026 Drug Name Tournament win  Ionis plots FDA filing after rare neurological disease candidate posts phase 3 win  See omnystudio.com/listener for privacy information.

Speed, precision, and visibility are critical to clinical trial success, and logistics plays a central role in delivering all three. In this interview, Manishaa O’Brien, director of commercial operations at Marken UPS Healthcare Precision Logistics, shares how the Laboratory Advantage service line is helping central labs and sponsors accelerate timelines while maintaining sample integrity and compliance.O’Brien discusses how Marken’s global network, combined with its air and ground fleet, connects clinical sites worldwide and expands access to diverse patient populations. She explains how enhanced tracking, integrated data systems and a 99.5% on-time performance rate support reliable, end-to-end visibility for lab partners. Dedicated account management and tailored logistics solutions further strengthen collaboration and help ensure regulatory requirements are met.The conversation also explores key trends shaping the future of clinical trial logistics, including increasing complexity, the rise of AI-driven routing and the growing importance of sustainability. From automation to eco-friendly packaging innovations, Marken is building a more efficient and resilient supply chain. Watch the full interview to learn how these advancements are helping clinical trials move faster and smarter.See omnystudio.com/listener for privacy information.

President Donald Trump has struck a deal with the UK that exempts prescription drugs imported to the United States from tariffs for three years. In exchange, Britain’s National Health Service will pay 25% more for new drugs. The question now is: Can the U.S. negotiate similar deals with other countries? In this week’s episode of "The Top Line," we examine the drug pricing agreement between the UK and the U.S. Fierce Pharma’s Kevin Dunleavy explores the issue with Jeffrey Gerrish, who served as deputy U.S. trade representative for Asia, Europe and the Middle East during the first Trump administration.  They break down the specifics of the UK-U.S. partnership and whether the deal could be applied to other countries to bring drug prices more in line with those in the U.S. They also discuss Trump’s other attempts to use America’s economic power to secure drug pricing agreements. To learn more about the topics in this episode:  UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract investments Merck executes its own Brexit, moving all R&D operations out of UK AstraZeneca's Soriot is considering move of stock listing to the US: Times See omnystudio.com/listener for privacy information.

Biomarkers are playing an increasingly critical role in shaping the future of oncology trials—and the pace of innovation is accelerating. In this sponsored episode of The Top Line, host Stephanie Butler sits down with Dr. Danielly Vicente, Associate Medical Director of Oncology and Hematology at Allucent, to explore how advanced biomarker strategies are transforming clinical development. From improving patient selection in early-phase trials to enabling adaptive study designs, biomarkers are helping researchers identify the right patients, optimize outcomes, and reduce development risks. Dr. Vicente discusses how approaches like comprehensive genomic profiling, basket and umbrella trials, and real-time monitoring are driving more efficient and successful oncology programs. The episode also tackles the challenges of integrating genomic testing and biomarker screening into trials, including operational complexity and data coordination. Plus, learn how emerging technologies such as circulating tumor DNA (ctDNA) and multiomic strategies are set to redefine trial design and accelerate precision medicine. Tune in to hear how biomarker-driven innovation is advancing oncology research—and what it means for the future of patient care.See omnystudio.com/listener for privacy information.

Spray-dried dispersions are widely used, but they do not always deliver expected results. In this sponsored episode of The Top Line, host Stephanie Butler speaks with AustinPx Chief Scientific Officer Dr. Dave Miller about how drug developers can recover from suboptimal formulations and manufacturing challenges. Miller outlines common issues, including poor bioperformance, inefficient scale-up, intellectual property limitations and high pill burden. He explains how next-generation amorphous solid dispersion technologies, such as KinetiSol, expand formulation design space, remove solvent constraints and support more efficient, scalable manufacturing. The conversation also covers how to introduce improved formulations into late-stage clinical programs and navigate regulatory considerations. Miller shares how teams can accelerate timelines while maintaining product quality and performance. For developers looking to optimize assets or reduce risk, this episode delivers clear, expert insight. Listen to the full interview to learn how to overcome formulation challenges and advance drug development.See omnystudio.com/listener for privacy information.

Artificial intelligence is increasingly shaping how pharma companies approach content strategy and decision-making. In this episode of The Top Line, Kristen Pilkiewicz, EVP and executive creative director at Sound Healthcare Communications, examines how AI is being applied in real-world marketing workflows. Rather than positioning AI as a standalone solution, Sound has integrated it into core processes to support faster content development, more rigorous strategy testing and improved alignment with regulatory expectations. Pilkiewicz outlines how the company is building tools tailored to pharma and training teams to use AI as a partner in decision-making. The discussion also explores PerspectiveX, an AI-powered decision intelligence platform that simulates health care provider reactions to content before it reaches market research. By helping teams refine messaging earlier, the tool aims to reduce bias, improve research inputs and strengthen overall campaign performance. For health care marketers and industry stakeholders, the conversation offers a grounded perspective on how AI is evolving from experimentation to practical application across the communications landscape.See omnystudio.com/listener for privacy information.

China’s biotech rise has been a persistent concern for federal health leaders, Congress, and many biopharma executives. But to Roivant CEO Matt Gline, the country is nothing more than a red herring.  In this week’s episode of "The Top Line," Fierce Biotech’s Darren Incorvaia chats with Gline about China, artificial intelligence and the exciting year ahead for Roivant’s lead asset brepocitinib.  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  NIH grant cuts hit women, early-career scientists the hardest: analysis  Roche pumps $480M into South Korea biopharma industry to establish global trial 'ecosystem'  Lilly pledges $500M to South Korea biopharma industry, following Roche’s lead  Pfizer-backed Priovant scores again with fast-rising brepocitinib in midstage study   See omnystudio.com/listener for privacy information.

The wait is over. Fierce Biotech has released its annual ranking of the top 10 pharma R&D budgets of 2025—offering a clear look at which companies are spending the most on innovation and how those investments are shifting year over year. In this week’s episode of "The Top Line," Darren Incorvaia and Eric Sagonowsky break down the new report, digging into who claimed the top spot, which companies moved up or down the rankings and whether any newcomers broke into the top 10. The conversation also explores the broader trends behind the budgets—what increased R&D investment signals about pipeline priorities, where companies may be pulling back and whether this year’s list reflects continued momentum or a plateau after several years of elevated spending. Listen to the full episode for a closer look at how the industry’s biggest players are allocating their R&D budgets—and what it could mean for the next wave of drug development. To learn more about the topics in this episode:  The top 10 pharma R&D budgets of 2025  Biopharma R&D pipeline shrinks for 1st time in 30 years: report  See omnystudio.com/listener for privacy information.

After a wave of high-profile pledges to bring pharmaceutical manufacturing back to the United States, a clearer picture of what reshoring actually looks like is starting to emerge. Tens of billions of dollars have been committed to new U.S. plants, but those investments are unlikely to translate into immediate gains in domestic production. In this week’s episode of "The Top Line," Fierce’s Eric Sagonowsky sits down with Rosemary Coates, executive director of the Reshoring Institute, to unpack where the trend stands today and what comes next. Coates explains why the pharma industry is uniquely positioned to bring supply chains back to the U.S., and the challenges companies face as they try to do it. To learn more about the topics in this episode:  UCB unveils plan to build $2B biologics plant near its US headquarters in Atlanta  Pharmas have promised $370B in US investments amid 2025's onshoring boom: DPR  Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report  See omnystudio.com/listener for privacy information.

While Lilly’s position in the obesity market and wider GLP-1 space has remained largely unshakeable in recent months, a crack in the company’s armor may be forming, according to at least one analyst. As that assessment dealt a blow to the company’s stock price in recent weeks, Lilly is plowing forward all the same with more details on its next wave of potential incretin drugs.   In this week’s episode of "The Top Line," the Fierce Pharma team breaks down Lilly’s recent HSBC downgrade, what it signals for the GLP-1 and obesity markets, and the data shaping the company’s next wave of diabetes and weight loss products. Fierce’s Eric Sagonowsky is joined by Kevin Dunleavy and Fraiser Kansteiner to unpack the latest and assess the commercial narrative around GLP-1s so far. To learn more about the topics in this episode:  With downgrade, HSBC casts doubt about Lilly's 'stairway to heaven' trajectory Lilly's triple-G bet lowers blood sugar, prompts 16.8% weight loss in phase 3 diabetes trial Lilly's obesity triple threat smashes efficacy expectations in phase 3 but proves intolerable for some Novo’s CagriSema tops semaglutide in ph. 3 diabetes study See omnystudio.com/listener for privacy information.

In this episode of The Top Line, host Chris Hayden speaks with Olive McCormick, Head of Quality and Qualified Person at Almac Clinical Services about why late‑breaking issues in clinical trials pose such significant risk — and what teams can do to prevent them. McCormick explains that operational misalignment, delayed communication, overlooked regulatory steps or misinterpretation of requirements under the new UK Clinical Trial Regulation can snowball quickly, putting both patient safety and organizational credibility at stake. She and Hayden discuss how sponsors, CROs and site teams can keep trials on track by establishing strong communication channels and maintaining a unified understanding of responsibilities as studies reach key milestones. McCormick stresses the value of proactive engagement and early insight into potential challenges, noting that waiting too long to identify or resolve issues increases the likelihood of disruptions. The episode calls on clinical research professionals to prioritize transparency, coordination and shared accountability. Whether you’re leading a trial or supporting one, the discussion offers practical guidance to help teams avoid the preventable setbacks that so often arise near the finish line.See omnystudio.com/listener for privacy information.

Since Xaira’s eye-popping $1 billion fundraise in 2024, the company has said relatively little in public. That’s made it one of biotech’s more closely watched black boxes: a company with enormous backing, enormous ambition and, until recently, few clues about what it has actually been building. In this week’s episode of “The Top Line,” Fierce Biotech’s Gabrielle Masson speaks with Xaira Chief Operating Officer Jeff Jonker about what the AI company is uncovering. Jonker discusses Xaira’s strategy as a next-generation biotech, the modalities and disease areas it is exploring, what he expects the industry to look like over the next five years and why Xaira is going after the “high-hanging fruit.” To learn more about the topics in this episode:  Xaira exec divulges R&D focus, how $1B fundraise fuels AI-driven hunt for what the 'industry is hungriest for' New AI drug discovery powerhouse Xaira rises with $1B in funding Biotech's top money raisers of 2024 See omnystudio.com/listener for privacy information.

In this week’s episode of “The Top Line,” we take a deep dive into the fourth-quarter performance of the biopharma industry and how the sector fared in 2025 overall. As the world’s 25 largest biopharma companies reported earnings, attention quickly shifted to their outlook for 2026. Only five drugmakers expect faster growth than in 2025, and some are projecting sales declines. One of the most surprising outlooks came from Novo Nordisk, which expects a significant drop in sales. Several other companies are also facing the loss of patent protection for blockbuster drugs, leading them to forecast either declining revenue or slower growth. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss the trends emerging from fourth-quarter earnings and how the industry’s performance compares with previous quarters. They also examine the intensifying GLP-1 competition between Novo Nordisk and Eli Lilly and how the two companies appear to be heading in opposite directions. To learn more about the topics in this episode:  Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4 As Lilly flourishes in Q4, peer projections signal looming sector slowdown in 2026 Biopharma industry gathers momentum in Q3 In Q3, drugmakers saw a marked decline in US vaccine sales as Eli Lilly kicked into higher gear See omnystudio.com/listener for privacy information.

The design of the modern R&D lab may be due for a rethink. Artificial intelligence and automation are reshaping how science gets done, yet many of the physical spaces where research happens were built around assumptions that date back decades. In this episode of “The Top Line,” Fierce Life Sciences & Healthcare Editor-in-Chief Ayla Ellison speaks with Gensler Global Sciences Practice Area Leader Ryley Poblete about how automation, data and new research workflows are influencing lab design. As computational scientists, engineers and automated systems become more central to research teams, organizations are reconsidering how labs should be structured to support both focused work and collaboration across disciplines.  See omnystudio.com/listener for privacy information.

Physiology connects genes and molecules to whole-body function, shaping every stage of drug discovery and development. In this sponsored episode of The Top Line, Sue Bodine, president-elect of the American Physiological Society and a professor at the Oklahoma Medical Research Foundation, explains why physiology remains central to biomedical innovation. Bodine details how physiology strengthens biotech and pharmaceutical research by clarifying how therapies behave in complex biological systems, identifying unintended effects and supporting stronger regulatory narratives. She also examines the expanding role of physiology in wearable technology, remote patient monitoring and artificial intelligence, where biological context is essential to turning large data sets into clinically meaningful insights. The episode also highlights the society’s campaign, “Physiology: The Science Life Depends On,” aimed at elevating awareness of foundational science amid funding uncertainty. For executives, investors and health care leaders seeking sustainable innovation and patient impact, this discussion underscores a clear message: Breakthroughs depend on physiology. Listen to the full interview.See omnystudio.com/listener for privacy information.

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules. In this week’s episode of "The Top Line," Fierce Pharma’s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency’s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency’s "case-by-case" approach, as indicated in the article, could be similar to—and different from—CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency. To learn more about the topics in this episode:  FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases  Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout  Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial  See omnystudio.com/listener for privacy information.

What does the future hold for sterile fill-finish CDMOs in a rapidly evolving market? In this sponsored episode of The Top Line, Denis Johnson, CEO of Grand River Aseptic Manufacturing, discusses the capacity crunch facing U.S. sterile manufacturing and what it means for healthcare stakeholders. As acquisitions reduce available capacity, Annex 1 drives preference for isolator technology, and companies reshore production, competition for specialized sterile fill expertise is intensifying. Johnson explains why segmentation and specialization are becoming critical differentiators in the CDMO space, particularly as biologics pipelines expand and product launches accelerate. He also shares how GRAM is investing in new facilities, high-volume syringe and cartridge capabilities, and workforce development to stay ahead of client demand while maintaining compliance and flexibility. For B2B healthcare professionals, marketers and payers seeking clarity on supply chain resilience and manufacturing strategy, this episode delivers timely insight. Listen now to explore how leading CDMOs are preparing for the next wave of sterile manufacturing demand.See omnystudio.com/listener for privacy information.

Though uncertainty still surrounds the Trump administration’s pharmaceutical import tariffs, the trade rhetoric set off a clear response across the industry in 2025. Drugmakers accelerated U.S. manufacturing plans, pushing production higher as companies looked to insulate their supply chains. Now, with many of those moves already underway, that breakneck pace is expected to level off through 2026 and 2027, according to a recent outlook from Atradius. In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner speaks with Brady McKinney, an underwriter for Atradius' pharmaceuticals sector focusing on the Americas, about the credit insurer's recent industry report. McKinney explains how tariff concerns drove last year’s manufacturing surge and why Atradius expects a period of stabilization ahead. He also discusses how companies are weighing the risk of future trade flare-ups and what that could mean for production, investment and credit conditions across the sector. To learn more about the topics in this episode:  Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program In quick reversal, Trump calls off tariff threat related to Greenland pursuit 3 biopharma CEOs explain why they are 'authentically optimistic' for 2026 See omnystudio.com/listener for privacy information.

Biopharmaceutical innovation is advancing at an unprecedented pace, yet many patients still face barriers to accessing new medicines. In this episode of Health Matters, John O’Brien, president and CEO of the National Pharmaceutical Council, speaks with Kristin Cahill about why policy, pricing and benefit design are increasingly shaping whether innovation reaches patients. O’Brien shares insights from his career spanning pharmaceutical companies, health plans and government, including his time as a senior drug pricing advisor during the first Trump administration. He explains why prescription drugs remain a focal point in cost debates, what policymakers often misunderstand about value, and how middlemen and misaligned incentives affect what patients pay at the pharmacy counter. The conversation also examines emerging approaches such as direct-to-patient models, most-favored-nation pricing and the early effects of the Inflation Reduction Act, highlighting potential benefits as well as risks to access and future innovation. For healthcare professionals, payers and marketers seeking clarity in a complex policy environment, this episode offers a grounded perspective on how to ensure medical breakthroughs translate into meaningful patient benefit. Listen to the full interview.See omnystudio.com/listener for privacy information.

Every clinical setback carries lessons. That’s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead. The 2025 edition of Fierce Biotech’s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate share of high-profile misses, reflecting the reality that many of the industry’s most ambitious late-stage programs now sit inside big pharma portfolios. On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development. To learn more about the topics in this episode:  2025's top 10 clinical trial flops Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma See omnystudio.com/listener for privacy information.

Community oncology is playing an increasingly important role in how cancer care is delivered across the United States, with a growing share of patients treated outside large academic medical centers. In this sponsored episode of The Top Line, host Chris Hayden sits down with Kirk Kaminsky, executive vice president and group president of North American Pharmaceutical Services for McKesson, to examine what this shift means for patients, providers and the industry. Kaminsky explains how advances in cancer science have transformed many diagnoses into long-term conditions, increasing the need for accessible, high-quality care in local communities. He discusses the challenges community practices face as innovation accelerates, including evolving reimbursement models, operational pressures and the adoption of new technologies. The conversation also explores the role of community oncology in expanding access to clinical trials and accelerating research, as well as how artificial intelligence is being used to improve both clinical and administrative workflows. Kaminsky shares his outlook on the next five to 10 years of cancer care and why supporting community oncology will be critical to continued progress. Listen to the full interview to learn more.See omnystudio.com/listener for privacy information.

The leaders of this year’s list of the most anticipated drug launches will likely come as no surprise: Fierce’s annual report on the biggest potential launches of 2026 details how the next obesity meds from Novo Nordisk and Eli Lilly are expected to rake in a respective $17.2 billion and $11.8 billion in annual sales by 2032, so long as they score their expected approvals this year. Elsewhere in the report are candidates from the likes of Gilead Sciences, Johnson & Johnson, AstraZeneca and other biopharmas big and small, spanning a range of indications from breast cancer to essential tremor. All together, predicted 2032 sales for the year’s top 10 weigh in at nearly $46 billion. In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, mapping out how it stacks up against last year’s edition and digging into the enormous sales potential of the top two drugs on the list.  To learn more about the topics in this episode:  Top 10 most anticipated drug launches of 2026 Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal Lilly's obesity pill largely maintains weight lost on injectable GLP-1s Top 10 most anticipated drug launches of 2025  See omnystudio.com/listener for privacy information.

Please see the following USPI, US ISI, EU SmPC and Canadian Product Monograph for complete LIVMARLI product information: US Important Safety Information (https://livmarli.com/important-safety-information/) US Prescribing Information (https://files.mirumpharma.com/livmarli/livmarli-prescribinginformation.pdf?_ga=2.264585739.54248471… EU SmPC (https://ec.europa.eu/health/documents/community-register/html/h1704.htm) Canadian Product Monograph (https://files.mirumpharma.com/livmarli/livmarli-product-monograph-en.pdf) Learn more about the latest research for Mirum’s investigational therapies: MRM-3379 (https://mirumpharma.com/wp-content/uploads/2025/09/FXS-NDD-2025-Mouse-Model-Poster_FINAL.pdf), volixibat in PSC  (https://s29.q4cdn.com/633867992/files/doc_presentations/2024/Jun/Mirum-VISTAS-and-VANTAGE-Interim-Analysis-Results-Presentation.pdf) and PBC (https://mirumpharma.com/wp-content/uploads/2025/05/Heneghan-M-EASL-2025-VANTAGE-28-week-data-with-volixibat-in-PBC.pdf), and brelovitug (https://www.natap.org/2025/AASLD/AASLD_22.htm). LIVMARLI is also currently being evaluated in the Phase 3 EXPAND study (https://clinicaltrials.gov/study/NCT06553768) in additional settings of cholestatic pruritus. References What is hepatitis delta? Hepatitis B Foundation. Accessed January 14, 2026. https://www.hepb.org/research-and-programs/hepdeltaconnect/what-is-hepatitis-delta/ Agarwal K, Jucov A, Dobryanska M, et al. Brelovitug (BJT-778) monotherapy achieved 100% virologic response in patients with chronic hepatitis D: on treatment week 48 phase 2 study results. Presented at: AASLD 2025; November 7-11, 2025; Washington, D.C. Sagnelli C, Sagnelli E, Russo A, Pisaturo M, Occhiello L, Coppola N. HBV/HDV co-infection: epidemiological and clinical changes, recent knowledge and future challenges. Life (Basel). 2021;11(2):169. doi:10.3390/life11020169 Negro F, Lok AS. Hepatitis D: a review. JAMA. 2023;330(24):2376-2387. doi:10.1001/jama.2023.23242 Hunter J, Rivero-Arias O, Angelov A, Kim E, Fotheringham I, Leal J. Epidemiology of fragile X syndrome: A systematic review and meta‐analysis. doi:10.1002/ajmg.a.36511  See omnystudio.com/listener for privacy information.