BUSINESS
    Fycompa Generics Approved despite Extended Patent, Hydrate Switch in Play?
    By Shinya Sato February 17, 2026
    Quick Look:Generics of Eisai’s Fycompa won approval despite an extended patent running through June, pointing to a possible hydrate-to-anhydrous switch to bypass protection.Whether the strategy will succeed remains unclear, given mixed precedents in recent patent…

    LATEST

    Espha Snags Bilanoa AG in Final Pre-Rule Approval Window
    February 17, 2026
    Quick Look:Espha gainedapproval for an authorized generic of Bilanoa as Japan plans pricing rule changes in October that will strip AGs of their price edge.The next generic listing round in June is widely seen as…
    10 Firms Win Approval for Bilanoa Generics, 2 Contenders for Fycompa
    February 17, 2026
    Quick Look:A broad slate of generics was approved ahead of the June NHI listing, led by 10 first entries for Bilanoa.First generics were also cleared for Revolade, Desalex, Fycompa, Amitiza, Cystadane, Toviaz, and Agrylin.-----Japan’s Ministry…
    MHLW to Brand OTC-Like Drug Cost Rule as “Partially Non-Insured Care”
    February 17, 2026
    Japan’s Ministry of Health, Labor and Welfare (MHLW) plans to introduce a new patient cost-sharing framework for so-called “OTC-like” prescription drugs under the name of “partially non-insured medical care,” Jiho has learned.The scheme will be…

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

    Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

    COMMENTARY

    Is Calling for an Abolition the Right Play? Rethinking Japan’s FY2027 Off-Year Drug Price Revision
    By Ken Yoshino

    Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…

    COLUMN

    AI in Healthcare Hiring: Leveling the Playing Field & Unlocking Human Potential
    By Philip Carrigan

    The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…

    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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