REGULATORY
    Novartis’ Radioligand Therapy, Other New Meds Up for Japan Panel Review on Aug. 22
    August 12, 2025
    A Japanese health ministry panel will meet on August 22 to consider approval of Novartis’ radioligand therapy lutetium vipivotide tetraxetan (177Lu) for certain prostate cancer patients and Servier’s glioma treatment vorasidenib, along with other new…

    LATEST

    Japan Nears Approval for 1st Biosimilars of Actemra, Simponi, and Ranmark
    August 12, 2025
    Japan is expected to soon approve its first biosimilar versions of Actemra (tocilizumab), Simponi (golimumab), and Ranmark (denosumab). If all goes without a hitch, they could win regulatory approval in September and join the NHI…
    Japan Approves FY2026 Budget Guidelines, Natural Increase at 400 Billion Yen
    August 12, 2025
    Japan’s Cabinet on August 8 approved the budget request guidelines, or “ceiling,” for FY2026, beginning next April. The plan allows an additional 400 billion yen in social security spending over the FY2025 initial budget to…
    PMDA Flags New Potential Risks for RAS Agents and Others
    August 12, 2025
    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is looking into new safety risks for a batch of medicines, among them being 27 renin-angiotensin system (RAS) agents including combo drugs. The review could lead to label…

    COMMENTARY

    As Japan’s Contract Drug Rep Ratio Rises, Expectations Grow for Specialist Talent and Flexible Workforce
    By Tatsuya Otsuka

    Japan’s contract drug rep ratio rose to 8.7% in FY2024 as the total number of regular reps continued to fall, the Japan Contract Sales Organization Association (JCSOA) reported in June. Amid industry downsizing, the roles and expectations placed on contract…

    COLUMN

    Beyond the Bench: Why Biopharma Needs Strategic Thinkers
    By Philip Carrigan

    A recent conversation with a US biopharma senior director highlighted a critical talent gap: a strong demand for individuals with strategic management, critical thinking, and advanced business acumen-skills beyond traditional operational excellence. After the conversation, I rushed home and picked…

    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 Debate on Off-Year Drug Price Revisions

    Chuikyo OKs Outline of FY2025 Off-Year Drug Price Revision
    By Ken Yoshino

    Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…

    TRENDS

    Top 10 PHARMA JAPAN Articles of 2024

    For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…

    MHLW Panel on Generic Industry Structure

    MHLW Panel Draws Up Plans for Generic Industry Shakeup in Final Report

    A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

    MHLW Panel on Pharmaceutical Regulations

    Regulation Panel’s Final Report Specifies Exemptions for All-Case PMS

    The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…

    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…

    MHLW Expert Panel on Comprehensive Policies

    Expert Panel Broadly OKs Draft Report on Pharma Policies, Further Deliberations by Other Forums
    By Yoshinori Sagehashi

    The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…

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