REGULATORY
    Astellas, Kyowa Kirin 1st Japan Pharmas to Cut US MFN Deals
    By Ken Yoshino September 1, 2026
    Astellas Pharma and Kyowa Kirin have reached agreements with the US government under its most-favored-nation (MFN) drug pricing policy, becoming the first Japanese drug makers to do so as Washington ratchets up efforts to bring…

    LATEST

    JGA Unveils Industry Vision 2035, Eyes Sustainable Structure
    September 2, 2026
    The Japan Generic Medicines Association (JGA) on August 31 unveiled its “generic medicines industry vision 2035,” setting out a roadmap for what the industry should look like in 2035 and the direction it should take…
    MHLW Seeks 13.9 Billion Yen to Boost Domestic Biosimilar Production
    September 2, 2026
    The Ministry of Health, Labor and Welfare (MHLW) is seeking 13.9 billion yen in its FY2027 budget request to support domestic biosimilar manufacturing facilities, aiming to reduce Japan’s reliance on overseas production and mitigate supply…
    Nonprescription Cialis Goes Nationwide in Japan, Now at 10,000 Outlets
    September 2, 2026
    SSP on August 31 began nationwide sales of Japan’s first nonprescription version of Cialis (tadalafil), an erectile dysfunction (ED) treatment, with the product now available at around 10,000 pharmacies and drug stores.Pharmacy chains that did…

    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…

    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…

    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…

    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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