Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
Japan’s health ministry on May 21 ordered Kissei Pharmaceutical to issue a “blue letter” rapid safety communication for its vasculitis drug Tavneos (avacopan) after serious liver injury cases, including fatalities, continued to accumulate in the country. The Ministry of Health,…
To read the full story
Related Article
- 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
- Panel Questions Timing of Tavneos Blue Letter Action
June 17, 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
- 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
- Japan to Designate International Clinical Trial Hubs in FY2027
August 28, 2026
- MHLW Tax Reform Requests Cover Support for MCM Preparedness
August 28, 2026
- Patient Group Flags Risks of Inconsistent Decisions on OTC-Like Drug Charges
August 28, 2026
- MHLW Pharma Bureau Eyes 12 Billion Yen to Boost Plasma Product Production
August 28, 2026
- Novo, Lilly Want Reimbursement Support for Obesity Care: LDP Hearing
August 28, 2026
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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…