REGULATORY
    MOF Pushes for Full-Scale FY2027 Off-Year Drug Price Revision Ahead of “Spring” Proposal
    April 28, 2026
    Japan’s finance ministry is pressing for the full implementation of the FY2027 off-year drug price revision, arguing that it should be carried out in the same manner as regular biennial revisions without limiting the scope…

    LATEST

    Japan Panel Backs Boehringer’s IPF Drug, Moderna COVID Vaccine
    April 28, 2026
    Quick Look:An MHLW panel recommended approval for two NMEs on April 27: Boehringer’s nerandomilast and Moderna’s mRNA COVID-19 vaccine.The session also backed label expansions for Sotyktu, Fasenra, and Alecensa, while the ministry reported plans to…
    Astellas Tops 2 Trillion Yen in Sales, Gears Up for Post-Xtandi Growth
    April 28, 2026
    Astellas Pharma posted record results for FY2025 ended March 2026, with revenue crossing the 2 trillion yen mark for the first time, supported by strong growth in key strategic products and ongoing cost-cutting efforts.“We have…
    Astellas Taps Sanofi Japan Chief Iwaya as Strategy Officer
    April 28, 2026
    Astellas Pharma said on April 27 that it will appoint Takahiko Iwaya as chief strategy officer (CStO) effective July 1, bringing in the outgoing Sanofi Japan president to lead its corporate strategy function.Iwaya currently serves…

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

    Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

    COMMENTARY

    Gene Therapies Expand into AMD, Raising Promise and Cost Concerns
    By Shinya Sato

    AAV (adeno-associated virus) gene therapies are moving beyond rare diseases into more prevalent conditions, with neovascular, or wet, age-related macular…

    COLUMN

    The Patient North Star: How Gilead Japan Redefined Innovation
    By Philip Carrigan

    In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…

    Drug Approval & Reimbursement in 2025

    Chuikyo OKs Listing of Novartis’ Pluvicto, Peak Sales Outlook at 42.1 Billion Yen

    Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

    Chuikyo Debate on Off-Year Drug Price Revisions

    MHLW Unveils New List Prices for FY2025 Revision; Stelara, Januvia Hit by PMP Return
    By Ken Yoshino

    The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…

    Discussions on Next PMD Act Amendment

    Japan Cabinet Approves Bill to Amend PMD Act

    The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

    Drug Approval & Reimbursement in 2024

    Japan Approves Zepbound, Qalsody, and Lots More Drugs

    Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

    Chuikyo on FY2024 Reimbursement Reform

    Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap

    Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

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