HOME > REGULATORY

    REGULATORY

    Janssen’s CAR-T Therapy, Kymriah Label Expansion Now in Line for Approval

    August 4, 2022
    Janssen Pharmaceutical’s CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) cleared the review of a key Japanese health ministry advisory committee on August 3, along with a label expansion for Novartis’ first-in-class product Kymriah (tisagenlecleucel). The Pharmaceutical Affairs and Food Sanitation Council’s…

    To read the full story

    Related Article

    REGULATORY

    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…

    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…

    COLUMN

    AI in HR: Navigating the Ethical Minefield
    By Philip Carrigan

    Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…

    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…