REGULATORY
    LDP Panel Chief Calls for Earlier CGP Coverage in Cancer Care
    By Kohei Hori September 4, 2026
    Japan should expand insurance coverage for comprehensive genomic profiling (CGP) testing so that cancer patients can undergo the tests from the early stages of treatment, ruling Liberal Democratic Party lawmaker Tamayo Marukawa told Jiho.Marukawa, chair…

    LATEST

    Fuji Curbs Shipments of Simponi, Ranmark Biosimilars Soon after Launch
    September 4, 2026
    Fuji Pharma has restricted shipments of its biosimilars of Simponi (golimumab) and Ranmark (denosumab) shortly after their Japanese launches this summer, despite being the sole company to enter the market with follow-ons to both products.The…
    Japan to Revisit Handling of Steroid Creams under OTC-Like Drug Charge
    September 4, 2026
    A health ministry panel is set to revisit whether topical steroids used for atopic dermatitis should be subject to Japan’s upcoming additional charge for “OTC-like” prescription medicines, after patient groups argued that the current proposal…
    UK Halts Tavneos for New Patients, Approval Revocation Set for March
    September 4, 2026
    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use, supply, and sale of avacopan to new patients after concluding that data from the pivotal study underpinning its approval can no longer be relied upon to demonstrate…

    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

    Pharma Faces Wage Challenge in 5% Era as Industry Sustainability at Stake
    By Hayate Horiguchi

    Japan has entered a third straight year of wage hikes averaging 5%, but the pharmaceutical industry is struggling to keep…

    COLUMN

    The One Mistake on Your Resume
    By Philip Carrigan

    We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…

    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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