REGULATORY
    Pharma Seeks Inflation-Liked Price Hikes, Freeze on Patent-Period Cuts for 2027 Revision
    By Kohei Hori August 27, 2026
    Japan’s pharmaceutical industry on August 26 pressed for measures to address mounting business pressures in the FY2027 off-year drug price revision, including NHI price hikes to reflect inflation and a freeze on price cuts for…

    LATEST

    Kisunla Braced for NHI Price Cut after CEA; Leqembi Method to Apply
    August 27, 2026
    Eli Lilly Japan’s Alzheimer’s treatment Kisunla (donanemab) is set for an NHI price reduction following its cost-effectiveness assessment (CEA), with the adjustment to be calculated under the same special method used for Eisai’s Leqembi (lecanemab).The…
    Xcopri, Leqembi SC Now in Line for Japan Approval with Panel Backing
    August 27, 2026
    A key Japanese health ministry panel on August 26 backed approval of Ono Pharmaceutical’s epilepsy drug cenobamate, known as Xcopri overseas, and a subcutaneous formulation of Eisai’s Alzheimer’s therapy Leqembi (lecanemab), along with other drugs…
    Meiji Wins Japan Approval for NB.1.8.1-Adapted COVID Vaccine
    August 27, 2026
    Meiji Seika Pharma said on August 26 that it has obtained Japanese regulatory approval for an updated version of its self-amplifying mRNA COVID-19 vaccine Kostaive targeting the Omicron NB.1.8.1 subvariant.The partial change approval, granted on…

    Chuikyo Debate on 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…

    COMMENTARY

    Beyond Dupixent: Next Wave of COPD Biologics Takes Shape
    By Shinya Sato

    More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…

    COLUMN

    Why Your Brain Wants You to Stay (Even When You Want to Go)
    By Philip Carrigan

    A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…

    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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