ACADEMIA
    Arava Safety Backup at Risk as Questran Supply Falters on Nitrosamine Issue
    By Sakura Kono May 11, 2026
    Sanofi’s Questran (colestyramine) is facing supply disruptions due to a nitrosamine issue, raising concerns among rheumatologists in Japan because the drug is the only approved treatment for managing serious side effects associated with the company’s…

    LATEST

    Daiichi Sankyo Cuts FY2025 Profit Outlook on ADC Supply Plan Review
    May 11, 2026
    Daiichi Sankyo slashed its FY2025 earnings forecast on May 8 after incurring large one-time costs tied to a review of its antibody drug conjugate (ADC) supply strategy, including losses tied to the cancellation of a…
    Capricor Sues Nippon Shinyaku over US Rights to DMD Cell Therapy
    May 11, 2026
    US biotech Capricor Therapeutics has filed a lawsuit seeking an injunction over its US commercialization agreement with Nippon Shinyaku for the Duchenne muscular dystrophy (DMD) cardiomyopathy therapy deramiocel, the Japanese company said on May 8.Deramiocel…
    FDA Delays Review of Leqembi Iqlik for Alzheimer’s Initiation Therapy
    May 11, 2026
    The US FDA has extended by three months its review of the subcutaneous autoinjector formulation of Eisai’s anti-amyloid antibody Leqembi (lecanemab), as a once-weekly initiation therapy for early Alzheimer’s disease. The new target action date…

    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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