REGULATORY
    Japan Weighs Scrapping “Spillover” Rule in Shift from Draft Reform Outline
    By Ken Yoshino December 24, 2025
    The Japanese government is adjusting its course on the drug pricing reform, with the possible abolition of the so-called “spillover” rule now under consideration after it was retained in an earlier draft for the FY2026…

    LATEST

    Heparinoid, Allergy Drugs among OTC-Like Meds Up for Special Charge Rule
    December 24, 2025
    Heparinoid moisturizers and a range of widely used allergy medicines are likely to be included in the 77 active ingredients slated for a new cost-sharing framework for “OTC-like” prescription drugs, it has been learned.The Liberal…
    Cyto-Facto Expands CPC Footprint to Win Multiple Cell Therapy Contracts
    December 24, 2025
    Cyto-Facto, a Kobe-based CDMO specializing in gene and cell therapies including CAR-T products, is stepping up investments in its cell processing centers (CPCs) — backed in part by a state subsidy — as it looks…
    Shionogi, Salubritas Tie Up on Hair Cell Regeneration R&D for Hearing Loss
    December 24, 2025
    Shionogi said on December 23 that it has signed a joint research and development agreement and an investment deal with US biotech Salubritas Therapeutics to pursue therapies that regenerate inner-ear hair cells to improve hearing…

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests
    By Takashi Ebisawa

    The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…

    COLUMN

    AI: Your New HR BFF (Not Your Replacement!)
    By Philip Carrigan

    Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…

    COMMENTARY

    Radioligand Therapy Faces Capacity Bottleneck in Japan, System Build-Out Needed to Deliver on Promise
    By Koji Shimomura

    Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…

    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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