The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Add Myasthenia Gravis, Myositis to Opdivo Label: MHLW
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on September 15, calling on Ono Pharmaceutical to revise the package insert for its anti-PD-1 antibody nivolumab (brand name: Opdivo) to add myasthenia gravis and myositis as clinically significant…
To read the full story
Related Article
- Thrombopenia Added to Clinically Significant ADR List for Daklinza, Sunvepra
October 28, 2015
- PMDA Reviewing Opdivo for Risk of Myasthenia Gravis
August 24, 2015
REGULATORY
- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
December 17, 2025
- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
December 16, 2025
- 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…