REGULATORY
    Extra Charges Likely for OTC-Like Drugs to Treat Seasonal Conditions: Minister
    April 22, 2026
    Japanese Health Minister Kenichiro Ueno said on April 21 that patients using “OTC-like” prescription drugs for seasonal symptoms — such as hay fever — would likely face additional out-of-pocket charges under the government’s planned reform…

    LATEST

    Lenvima-Keytruda Triplets Fail in First-Line RCC Trial
    April 22, 2026
    Eisai and US Merck said on April 21 that two triplet combination regimens missed the primary endpoints in a global PIII trial evaluating the first-line treatment for advanced clear cell renal cell carcinoma (RCC), including…
    Another Global PIII Shuttered for Arcus-Partnered TIGIT Combo: Taiho
    April 22, 2026
    Taiho Pharmaceutical said on April 21 that another global PIII study on a combination therapy involving domvanalimab — an anti-TIGIT antibody that it has licensed in Japan from US biotech Arcus Biosciences — was discontinued…
    MHLW Orders Label Revisions for Remicade, Enbrel, Bavencio, and More Drugs
    April 22, 2026
    Japan’s Ministry of Health, Labor and Welfare (MHLW) on April 21 ordered safety-related label revisions for a range of medicines, including TNF inhibitors Remicade (infliximab) and Enbrel (etanercept), as well as their biosimilars.For Tanabe Pharma’s…

    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…

    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…

    COMMENTARY

    Challenges in a Post-AG Era: Ensuring a Reliable Supply System
    By Tatsuya Otsuka

    Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…

    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…

    NEWS CATEGORY

    REGULATORY

    BUSINESS

    ORGANIZATION

    ACADEMIA