ACADEMIA
    Tavneos Data Integrity Issue Could Spill Over to Japan, Investigator Warns
    By Takashi Ebisawa June 2, 2026
    A leading Japanese investigator involved in the pivotal clinical trial of Tavneos (avacopan) has expressed concerns that data integrity issues surrounding the vasculitis drug could ultimately affect its approval status in Japan — a prospect…

    LATEST

    LDP Panel Approves Honebuto Proposal on Preventive Healthcare
    June 2, 2026
    A Liberal Democratic Party (LDP) panel on proactive preventive healthcare on June 1 broadly approved a proposal calling for measures to maintain and strengthen the manufacturing capacity for products covered under Japan’s national immunization program.The…
    LDP Patch League to Seek Drug Price Support in Honebuto Proposal
    June 2, 2026
    A Liberal Democratic Party (LDP) lawmakers’ league promoting Japan’s topical patch industry on June 1 approved a proposal for the government’s 2026 Basic Policy on Economic and Fiscal Management and Reform (honebuto), calling for measures…
    J&J’s Tremfya Now Available for Self-Injection in IBD
    June 2, 2026
    Janssen Pharmaceutical (J&J) said on June 1 that the 200 mg subcutaneous formulations of Tremfya (guselkumab) are now available for self-injection at home for the treatment of ulcerative colitis and Crohn’s disease in Japan.The move follows a decision by the…

    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

    Are Technical Discussions Enough for Japan’s CEA System?
    By Ken Yoshino

    Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…

    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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