REGULATORY
    Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
    May 1, 2026
    A health ministry panel on April 30 endorsed a proposal that could pave the way for including antibody-based drugs such as Sanofi’s RSV preventive Beyfortus (nirsevimab) in Japan’s national immunization program (NIP).The proposal, adopted by…

    LATEST

    MHLW Issues Q&A on Conditional Approval System
    May 1, 2026
    Japan’s health ministry has issued a Q&A document clarifying how the country’s revised conditional approval system for drugs will be operated, following earlier guidance on the amended Pharmaceuticals and Medical Devices (PMD) Act, which took…
    JPMA Launches New Legal Entity, Set for October Transition
    May 1, 2026
    The Japan Pharmaceutical Manufacturers Association (JPMA) on May 1 formally established a general incorporated association as part of its transition from a voluntary organization, with a full shift scheduled for October.The move coincides with the…
    Leqembi FY2025 Global Sales Reach 88 Billion Yen: Eisai
    May 1, 2026
    Eisai said on April 29 that global sales of its Alzheimer’s disease therapy Leqembi (lecanemab) totaled 88 billion yen on a pre-audit basis for FY2025, which ended March 2026.By market, revenue came to 44.6 billion…

    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

    Shift Underway in Pharma Workforce as Sales Roles Shrink, Manufacturing Rises
    By Hayate Horiguchi

    Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…

    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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