BUSINESS
    Sawai’s Solo Tenelia Copy Raises Patent Questions Ahead of December Listing
    By Shinya Sato August 21, 2026
    Sawai Pharmaceutical’s solo generic approval for Tanabe Pharma’s DPP-4 inhibitor Tenelia (teneligliptin) has put the spotlight on whether the generic major has found a way around the originator’s remaining patents — and whether it will…

    LATEST

    Gilead Files CAR-T Therapy Tecartus in Japan for MCL, B-ALL
    August 21, 2026
    Gilead Sciences said on August 21 that it has filed its CAR-T cell therapy brexucabtagene autoleucel (brexu-cel), marketed overseas as Tecartus, for approval in Japan for relapsed or refractory mantle cell lymphoma (MCL) and B-cell…
    Tiger, Gaudi Develop Compact Cell Transport Container
    August 21, 2026
    Japanese home appliance maker Tiger and regenerative medicine startup Gaudi Clinical said on August 20 that they have jointly developed a compact vacuum-insulated container for transporting medical specimens, targeting commercialization in 2027.Called the “cell pod,”…
    DT-Axis Charts Path to 2nd-Stage DTx Approval with Depression App
    August 21, 2026
    DT-Axis is looking to blaze a trail toward Japan’s first full approval of a digital therapeutic (DTx) under the country’s two-stage pathway, building real-world evidence for its depression treatment support app Lifton D after securing…

    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…

    COMMENTARY

    Signs of Shift in Japan’s Drug Policy, but Cost Pressures Persist
    By Kohei Hori

    Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…

    COLUMN

    Why Your Brain Wants You to Stay (Even When You Want to Go)
    By Philip Carrigan

    A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…

    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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