The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Paper Retraction Won’t Impact Zolgensma Japan Approval, Data Deleted from Label
Japanese approval for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) will remain intact despite the recent retraction of a 2010 paper featuring animal study data on the treatment, with regulators upholding their assessment for efficacy and safety. The Ministry of Health,…
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- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
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- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
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- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 2025
- MHLW Council Determines 3 “Drug Loss” Products as High-Need, to Seek Development
December 16, 2025
- LDP Biosimilar Group Submits Request to Finance Minister, Seeks Continued Support
December 16, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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…
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…