REGULATORY
    Unpacking “MFN”: Japan Listed as Reference Country in US Pricing Models
    By Ken Yoshino April 16, 2026
    The contours of the US “most-favored-nation (MFN)” drug pricing policy are coming into sharper focus, with Japan explicitly named as a reference country in official documents from US health authorities.Documents released by the Centers for…

    LATEST

    MSD Debuts HIV Drug Idvynso in Japan in World-First Launch
    April 16, 2026
    MSD launched its once-daily oral HIV-1 treatment Idvynso (islatravir + doravirine) in Japan on April 15, marking the product’s first commercial rollout globally.Idvynso is a fixed-dose combination of the novel nucleoside reverse transcriptase translocation inhibitor…
    GSK’s Long-Acting Asthma Drug Exdensur Now Available in Japan
    April 16, 2026
    GSK said on April 15 that it has launched its anti-IL-5 monoclonal antibody Exdensur (depemokimab) in Japan as a long-acting biologic option for the treatment of asthma and chronic rhinosinusitis.The drug — available as a…
    MHLW to Set Criteria for Exemptions under OTC-Like Drug Charge Scheme
    April 16, 2026
    The Ministry of Health, Labor and Welfare (MHLW) plans to establish criteria for patients who would be exempt from additional charges under the proposed system for “OTC-like” prescription drugs, a senior MHLW official said on…

    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 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…

    COMMENTARY

    Challenges in a Post-AG Era: Ensuring a Reliable Supply System
    By Tatsuya Otsuka

    Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…

    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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