REGULATORY
    New MHLW Pharma Chief Puts AI in Regulatory Reviews High on Agenda
    September 3, 2026
    Hiroyuki Uchiyama, the new head of the health ministry’s Pharmaceutical Safety Bureau, has signaled that harnessing artificial intelligence in drug reviews will be a key priority, as the technology rapidly gains traction in pharmaceutical R&D.“We…

    LATEST

    MHLW Insurance Chief Vows Thorough Outreach on OTC-Like Drug Charges
    September 3, 2026
    The Ministry of Health, Labor and Welfare (MHLW) will work to ensure that patients and healthcare professionals are well informed about a new charge for certain “OTC-like” prescription drugs ahead of its planned rollout next…
    Halaven Generics Obtain Soft Tissue Sarcoma Use
    September 3, 2026
    Nichi-Iko Pharmaceutical and Nipro said on September 2 that their generic versions of the cancer drug Halaven (eribulin) have won an additional indication for soft tissue sarcoma.The generics, Eribulin Mesilate IV Injection “Nichi-Iko” and “Nipro,”…
    Ono Teams with Aitia in AI-Driven Neurology Drug Discovery
    September 3, 2026
    Ono Pharmaceutical said on September 2 that it has forged a drug discovery partnership with Aitia, a US biotech specializing in AI-powered drug discovery, to identify new therapeutic targets in neurological diseases.Under the deal, Ono…

    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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