BUSINESS
    Lundbeck Japan Boosts Workforce 20% as It Revs Up Domestic Operations
    By Koji Shimomura October 28, 2026
    Lundbeck Japan has expanded its workforce by roughly 20% since last year as it builds up its commercial and organizational capabilities for its first solo launch now awaiting NHI listing, with two late-stage therapies in…

    LATEST

    Alzheimer’s Pipeline Looks Past Amyloid to Earlier Intervention, Tau Targets
    October 28, 2026
    The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s, but their modest clinical impact has already turned attention to the next generation of treatments.Both…
    Japan Eyes Priority Review for MCMs, Bill Submission Planned for 2027
    October 28, 2026
    A Japanese health ministry panel on October 27 broadly backed a proposal to explicitly designate medical countermeasures (MCMs) as eligible for priority review under the Pharmaceuticals and Medical Devices Act, with legislation expected to be…
    Panel Member Urges Review of Tavneos Blue Letter Timing
    October 28, 2026
    A member of a Japanese health ministry panel on October 27 called for a review of whether a “blue letter” rapid safety communication for Kissei Pharmaceutical’s vasculitis drug Tavneos (avacopan) was issued at an appropriate…

    COLUMN

    New York Note - 1: JETRO’s Role in Connecting Japan with the World
    By Shunsuke Tani

    PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…

    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…

    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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