BUSINESS
    DMD Gene Therapy Elevidys Hits Japan Market at Record Price
    February 20, 2026
    Chugai Pharmaceutical on February 20 launched its Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec) in Japan at a price of nearly 305 million yen — the highest ever set under the country’s drug…

    LATEST

    Japan Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
    February 20, 2026
    Japan granted regulatory approvals for a batch of new medicines and label expansions on February 19 including AbbVie’s migraine therapy Aquipta (atogepant) and Novo Nordisk’s once-weekly insulin-GLP-1 combo Kyinsu (insulin icodec + semaglutide), otherwise known…
    Health Minister Signals Early March Approval for iPSC Products
    February 20, 2026
    Japan could grant conditional and time-limited approval early next month for what would be the world’s first induced pluripotent stem cell (iPSC)-derived medical products, Health Minister Kenichiro Ueno said.Speaking at a press conference on February…
    JPMA to Push Govt to Scrap Market-Based Drug Price Revisions
    February 20, 2026
    The Japan Pharmaceutical Manufacturers Association (JPMA) has for the first time called for abolishing Japan’s market-based drug price revision system, arguing that shrinking price gaps call into question whether actual market prices should remain as…

    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…

    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…

    COMMENTARY

    Hisamitsu’s MBO: Is Shareholder Accountability Trust-Building or a Shackle?
    By Hayate Horiguchi

    Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…

    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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