REGULATORY
    Revolade, Bilanoa See First Generics in June Listing; 3 Final AGs on Roster
    By Kohei Hori June 11, 2026
    Japan’s health ministry will list first generics for 10 APIs in the next round of biannual generic listing on June 12, including Novartis’ Revolade (eltrombopag olamine), Taiho Pharmaceutical’s Bilanoa (bilastine), and Eisai’s Fycompa (perampanel hydrate),…

    LATEST

    Official Hints at Potential Change to Growth Target in Draft Roadmap
    June 11, 2026
    A growth target for patented medicines included in the government’s planned public-private investment roadmap could be revised from the draft outlined in March, a senior Cabinet Office official suggested on June 10.Speaking at a Tokyo…
    Lilly Warns Against Off-Label Use of Mounjaro
    June 11, 2026
    Eli Lilly Japan on June 10 issued a statement urging for the appropriate use of its type 2 diabetes drug Mounjaro (tirzepatide), following reports of advertisements promoting the drug for cosmetic purposes and unauthorized sales…
    BMS Seeks Japan Approval for Mezigdomide in Multiple Myeloma
    June 11, 2026
    Bristol Myers Squibb said on June 10 that it has filed a new drug application in Japan for its investigational cancer drug mezigdomide for the treatment of relapsed or refractory multiple myeloma.The filing is primarily…

    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

    20 Years at a Glance: Overseas Sales Surge at Japan Pharma, but R&D Investments Lag
    By Hayate Horiguchi

    Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…

    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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