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The Top Line

Fierce Life Sciences
The Top Line
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152 episódios

  • The Top Line

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

    16/2/2026 | 27min
    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.
  • The Top Line

    What were the biggest clinical trial flops of 2025?

    13/2/2026 | 19min
    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.
  • The Top Line

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

    09/2/2026 | 15min
    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 Top Line

    The biggest potential drug launches of 2026

    06/2/2026 | 13min
    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.
  • The Top Line

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

    03/2/2026 | 14min
    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.

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Sobre The Top Line

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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