BUSINESS
    Asahi Kasei to Buy German Antiviral Specialist Aicuris for 143.1 Billion Yen
    By Kohei Hori February 27, 2026
    Quick Look:Asahi Kasei is expanding its pharma footprint through a €780 million deal for Germany’s Aicuris, advancing its drive toward 300 billion yen in sales by FY2030.The transaction adds royalty income from Prevymis and antiviral…

    LATEST

    Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
    February 27, 2026
    Celltrion Healthcare Japan’s biosimilar of Eylea (aflibercept) is nearing approval, with a decision expected as early as March. However, uncertainty remains over its NHI listing timing due to patent issues surrounding the diabetic macular edema…
    Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
    February 27, 2026
    Quick Look:Three NMEs are set for approval review by an MHLW panel on March 5: OrphanPacific’s leniolisib, Ultragenyx’s triheptanoin, and Bayer’s gadoquatrane.The agenda also includes label expansions for Lusefi and Effexor, a new Eylea biosimilar…
    GSK Files Hep B Drug in Japan as First Global Submission
    February 27, 2026
    GSK said on February 26 that it has filed a new Japanese drug application for bepirovirsen for the treatment of adults with chronic hepatitis B. Japan is the first country globally where the company has…

    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

    G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands
    By Shinya Sato

    Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…

    COLUMN

    The Strategic MSL: Beyond Data Delivery, It’s About Impact
    By Philip Carrigan

    I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…

    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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