Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Panel Questions Timing of Tavneos Blue Letter Action
Members of a health ministry oversight panel on June 16 questioned whether a “blue letter” rapid safety communication for Kissei Pharmaceutical’s vasculitis drug Tavneos (avacopan) could have been issued earlier following fatal cases of liver injury linked to the treatment.…
To read the full story
Related Article
- Tavneos Blue Letter Action “Too Slow,” MHLW Panel Member Says
September 18, 2026
- UK Halts Tavneos for New Patients, Approval Revocation Set for March
September 4, 2026
- Kissei Slashes Tavneos Sales Forecast after Safety, Data Concerns
August 3, 2026
- MHLW Gives Kissei until July 21 to Report on Tavneos
July 3, 2026
- NEJM Retracts Paper on Tavneos’ Pivotal Study
July 1, 2026
- Kissei Discussing Japan Response after EU Panel Recommends Pulling Tavneos Approval
June 29, 2026
- MHLW to Continue Reviewing Tavneos Safety Measures: Official
June 10, 2026
- Tavneos Data Integrity Issue Could Spill Over to Japan, Investigator Warns
June 2, 2026
- Kissei Drops Call to Halt New Tavneos Use after Blue Letter Action
May 22, 2026
- Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
May 22, 2026
- MHLW Orders Detailed Report on Tavneos Efficacy Concerns
May 20, 2026
- Japan to Swiftly Consider Safety Measures over Tavneos: Minister
May 19, 2026
- Kissei Urges Halt to New Tavneos Use after Fatal Liver Injury Reports
May 18, 2026
REGULATORY
- Chuikyo Backs Broader CEA Price Cuts This Year, Snubs Pharma Plea
October 1, 2026
- Repatha Optimal Use Guidelines to Be Simplified
October 1, 2026
- Label Revisions Ordered for Checkpoint Inhibitors over Gastritis, Esophagitis
September 30, 2026
- MHLW Panel Backs Easing Protopic Contraindication for Young Children
September 30, 2026
- PMDA Flags New Safety Risks with 3 Drugs
September 30, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
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…