The Top Line

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.