REGULATORY
    Japan Weighs Possible Approval Revocation for Tavneos, Action Against Kissei
    By Hayate Horiguchi October 22, 2026
    Kissei Pharmaceutical’s vasculitis drug Tavneos (avacopan) could lose its Japanese approval after regulators found that pivotal clinical trial data failed to meet reliability standards. The Ministry of Health, Labor and Welfare (MHLW) plans to decide…

    LATEST

    Hernexeos, Rinvoq, Tukysa Label Expansions Now in Line for Japan Approval
    October 22, 2026
    A key Japanese health ministry panel on October 21 backed label expansions for the first-line use of Nippon Boehringer Ingelheim’s HER2 tyrosine kinase inhibitor Hernexeos (zongertinib) and an additional alopecia areata indication for AbbVie’s JAK…
    First iPS Heart Sheet Patient Recovering Well, Set for Discharge
    October 22, 2026
    A woman who became the first patient to receive an approved iPSC-derived cardiomyocyte sheet transplant said on October 21 that she could breathe much more deeply following the procedure. She is scheduled to be discharged from Osaka Keisatsu Hospital on…
    PreMedica Hit by Unauthorized Access; No Data Leak Confirmed
    October 22, 2026
    PreMedica, a consolidated subsidiary of wholesaler Medipal Holdings, said on October 21 that it has taken its website offline after detecting unauthorized access by a third party.The company, which offers testing services to assess the risks of stroke and heart…

    Cost Effectiveness Assessment (2025-)

    LDP Health Chief Demands CEA Overhaul, Backs Freeze on Price Cuts
    By Takashi Ebisawa

    Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…

    COMMENTARY

    Lp(a) Drugs Face Next Test in Quest to Cut Cardiovascular Risk
    By Koji Shimomura

    Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…

    Off-Year Drug Price Revisions

    Japan to Weigh Necessary Measures for FY2027 Revision: PM

    Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…

    Drug Approval & Reimbursement in 2026

    Imulrio Finally Set for NHI Listing after 296-Day Wait; Zero Rule Strikes Again
    By Takashi Ebisawa

    Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…

    COLUMN

    Outside the Bubble: Lunch with Pharma Delegates
    By Philip Carrigan

    The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…

    FY2026 Drug Pricing Reform

    Romiplate to See Steepest Cut in April Market Expansion Re-Pricing

    Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

    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,…

    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…

    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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