BUSINESS
    Pharma Earnings Season Kicks Off; Off-Year Impact, Overseas Trends in Focus
    April 24, 2026
    Japan’s pharma earnings season begins on April 24, with Chugai Pharmaceutical reporting its January-March scorecard. All eyes will be on the impact of the FY2025 off-year revision and the growing share of overseas revenue as…

    LATEST

    Gene Therapies Expand into AMD, Raising Promise and Cost Concerns
    April 24, 2026
    AAV (adeno-associated virus) gene therapies are moving beyond rare diseases into more prevalent conditions, with neovascular, or wet, age-related macular degeneration (AMD) emerging as a key battleground. The prospect of one-time therapies is drawing attention,…
    Gilead Files Trodelvy-Keytruda Combo for 1L TNBC in Japan
    April 24, 2026
    Gilead Sciences said on April 23 that it has filed in Japan for a label expansion of its antibody drug conjugate (ADC) Trodelvy (sacituzumab govitecan) for use in combination with the anti-PD-1 antibody Keytruda (pembrolizumab)…
    JPWA Urges Caution on Fixed Margins, Citing French Model Shortcomings
    April 24, 2026
    The head of Japan’s pharmaceutical wholesalers group on April 23 urged caution over adopting a government-set margin system, saying a review of France’s model found it offers little assurance of sustainable operations or stable supply.Hiromi…

    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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