The Top Line

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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. 

  1. 8 HR AGO

    Autoimmune CAR-T: Navigating the FDA’s new regulatory playbook

    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.

    23 min
  2. Inside the sterile fill capacity crunch (Sponsored)

    4 DAYS AGO

    Inside the sterile fill capacity crunch (Sponsored)

    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.

    10 min
  3. Trump's tariff threats, measured by manufacturing

    20 FEB

    Trump's tariff threats, measured by manufacturing

    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.

    15 min
  4. Why patient access must keep pace with drug innovation (Sponsored)

    16 FEB

    Why patient access must keep pace with drug innovation (Sponsored)

    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.

    27 min

  5. 13 FEB

    What were the biggest clinical trial flops of 2025?

    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.

    20 min
  6. Community oncology’s growing role in the future of cancer care (Sponsored)

    9 FEB

    Community oncology’s growing role in the future of cancer care (Sponsored)

    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.

    15 min
  7. The biggest potential drug launches of 2026

    6 FEB

    The biggest potential drug launches of 2026

    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.

    13 min
  8. How Mirum is Advancing Rare Disease Care Through Strategic M&A (Sponsored)

    3 FEB

    How Mirum is Advancing Rare Disease Care Through Strategic M&A (Sponsored)

    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.

    15 min
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About

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. 

Information

  • Creator
    Fierce Life Sciences
  • Years Active
    2023 - 2026
  • Episodes
    100
  • Rating
    Clean
  • Show Website
    The Top Line

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