REGULATORY
    Tavneos Slapped with Blue Letter in Japan over Liver Injury Risk
    May 21, 2026
    Japan’s health ministry on May 21 issued a “blue letter” safety warning for Kissei Pharmaceutical’s vasculitis drug Tavneos (avacopan) after serious liver injury cases, including fatalities, continued to accumulate in Japan.The Ministry of Health, Labor…

    LATEST

    BMS, Nikon Pitch Japan-to-Asia Cell Therapy Push, Draw Support at Policy Forum
    May 21, 2026
    Bristol Myers Squibb and Nikon Cell Innovation (NCLi) on May 20 reiterated their push to build a Japan-based manufacturing platform for CAR-T therapies with an eye toward the broader expansion into Asia around 2030 —…
    MHLW Moves Toward Immunization Act Revision for RSV Antibody Drugs
    May 21, 2026
    Japan’s health ministry on May 20 reported to an expert panel a proposal that would position antibody-based drugs as eligible products under the Immunization Act, setting the stage for the potential routine immunization coverage of…
    Fuji Plans July Launch for Japan’s 1st Simponi, Ranmark Biosimilars
    May 21, 2026
    Fuji Pharma plans to launch biosimilar versions of Simponi (golimumab) and Ranmark (denosumab) — both the first in Japan — around July, the company said.The products were approved in September last year and added to…

    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

    Shift Underway in Pharma Workforce as Sales Roles Shrink, Manufacturing Rises
    By Hayate Horiguchi

    Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…

    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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