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  • Pharmaceutical Executive Daily: Carvykti Demonstrates Sustained Remissions

    Pharmaceutical Executive Daily: Carvykti Demonstrates Sustained Remissions
    2025/12/09
    In today’s Pharmaceutical Executive Daily, new analysis outlines how EMA support programs help lower drug market entry costs, early real-world data show sustained remissions with Carvykti in relapsed or refractory multiple myeloma, and Pfizer signs an exclusive collaboration with Yao Pharma to advance oral small-molecule GLP-1 agonists.
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    2 分
  • Pharmaceutical Executive Daily: FDA Approves Breyanzi

    Pharmaceutical Executive Daily: FDA Approves Breyanzi
    2025/12/08
    In today’s Pharmaceutical Executive Daily, the FDA greenlights an expanded use of Breyanzi, Eli Lilly reports Jaypirca met its primary endpoint in a head-to-head Phase III trial against Imbruvica for CLL/SLL, and new analyses highlight how health systems are strengthening partnerships to support cell and gene therapy commercialization.
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    2 分
  • Pharmaceutical Executive Daily: Mark Cuban's Push for Generic Drug Fee Waivers

    Pharmaceutical Executive Daily: Mark Cuban's Push for Generic Drug Fee Waivers
    2025/12/05
    In today’s Pharmaceutical Executive Daily, former FDA commissioners caution that new vaccine policies could weaken long-established regulatory standards, Mark Cuban urges federal officials to waive fees to boost generic drug competition, and a new report reveals patients are increasingly avoiding care due to rising healthcare costs.
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    2 分
  • Pharmaceutical Executive Daily: FDA Names Tracy Beth Høeg as Acting Director of CDER

    Pharmaceutical Executive Daily: FDA Names Tracy Beth Høeg as Acting Director of CDER
    2025/12/04
    In today’s Pharmaceutical Executive Daily, the FDA appoints Tracy Beth Høeg as acting CDER director, health systems explore new commercialization partnerships for cell and gene therapies, and Aidoc submits a breakthrough-designated multi-triage AI device for FDA approval.
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    2 分
  • Pharmaceutical Executive Daily: FDA's Agentic AI Deployment

    Pharmaceutical Executive Daily: FDA's Agentic AI Deployment
    2025/12/03
    In today’s Pharmaceutical Executive Daily, Regeneron launches a $150 million gene editing collaboration with Tessera Therapeutics, the FDA begins agency-wide deployment of new agentic AI tools, and a new report suggests Richard Pazdur is stepping down as director of CDER.
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    2 分
  • Pharmaceutical Executive Daily: Lilly Reduces the Price of Zepbound

    Pharmaceutical Executive Daily: Lilly Reduces the Price of Zepbound
    2025/12/02
    In today’s Pharmaceutical Executive Daily, Eli Lilly reduces the price of Zepbound single-dose vials for self-pay patients, a new report claims the FDA is planning changes to its vaccine approval process following assertions of COVID vaccine–related deaths, and Korea and Australia reorient their pharma launch strategies toward broader regional market opportunities.
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    2 分
  • Pharmaceutical Executive Daily: U.S. & U.K. Agree to 0% Tariffs on Pharmaceutical Products

    Pharmaceutical Executive Daily: U.S. & U.K. Agree to 0% Tariffs on Pharmaceutical Products
    2025/12/01
    In today’s Pharmaceutical Executive Daily, Novo Nordisk files for FDA approval of a higher-dose Wegovy injectable using a priority review voucher, the US and UK agree to eliminate tariffs on pharmaceutical products, and CMS publishes major price cuts for 15 high-cost Medicare drugs under the latest IRA negotiation round.
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    2 分
  • Pharmaceutical Executive Daily: Novartis Cuts 550 Jobs

    Pharmaceutical Executive Daily: Novartis Cuts 550 Jobs
    2025/11/26
    In today’s Pharmaceutical Executive Daily, Novartis plans to eliminate 550 positions at a major Swiss site, the FDA authorizes the first gene therapy for adolescents and adults with spinal muscular atrophy, and industry experts weigh in on how next-generation CDMOs are evolving to meet rapid market change.
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    2 分