BUSINESS
    Recordati Urges Rethink of Zero-Premium Rule on Cost Disclosure
    By Kimi Orita August 31, 2026
    Recordati Rare Diseases Japan President Shoji Kuroyama has called on Japan to revisit a pricing rule that wipes out premiums when drug makers disclose less than 50% of the manufacturing costs of new medicines priced…

    LATEST

    MHLW Eyes Tax Exemption for OTC-Like Drug Charges
    September 1, 2026
    The Ministry of Health, Labor and Welfare (MHLW) is seeking to permanently exempt from consumption tax the additional patient charges under Japan’s upcoming scheme for “OTC-like” prescription medicines, it was learned on August 31.The ministry…
    SanBio to Move All Akuugo Manufacturing to Minaris’ Yokohama Site
    September 1, 2026
    SanBio said on August 31 that it will shift the entire manufacturing process for its cell therapy Akuugo (vandefitemcel) to Minaris Advanced Therapies’ Yokohama plant following the closure of the CDMO’s Mountain View facility in…
    Cabinet Office Seeks 22 Billion Yen for Clinical Trial Subsidies
    September 1, 2026
    The Cabinet Office is seeking 22 billion yen for FY2027 to subsidize clinical trial costs as part of new investments in drug discovery and advanced medicine, according to its budget request outline released on August…

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Romiplate to See Steepest Cut in April Market Expansion Re-Pricing

    Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

    COLUMN

    The One Mistake on Your Resume
    By Philip Carrigan

    We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…

    COMMENTARY

    Beyond Dupixent: Next Wave of COPD Biologics Takes Shape
    By Shinya Sato

    More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…

    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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