The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Guidance on Companion Diagnostics Calls for Inclusion of Biomarker-Negative Subjects in Clinical Studies
The Pharmaceutical and Food Safety Bureau’s Evaluation and Licensing Division has issued a technical guidance on the development of companion diagnostics (CoDx) and related drugs to prefectures. The guidance covers items to keep in mind when developing drugs and CoDx…
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- Japan Weighs Scrapping “Spillover” Rule in Shift from Draft Reform Outline
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- Heparinoid, Allergy Drugs among OTC-Like Meds Up for Special Charge Rule
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- Japan Hands Out Orphan Designation to 11 Drugs
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- Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
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- Japan, Spain Move to Deepen Pharmaceutical Regulatory Cooperation
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Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…