Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Causal Link between Eisai’s Epilepsy Drug and Trial Death Can’t Be Ruled Out: MHLW
The Ministry of Health, Labor and Welfare (MHLW) on November 29 issued a report on its investigation into the death of a young man who had received Eisai’s experimental epilepsy medicine in an early clinical trial in Japan, concluding that…
To read the full story
Related Article
- MHLW Revises Safety Guidance on FIH Studies Following Death of Subject
January 6, 2020
- Eisai Discontinues Development of Epilepsy Drug after Death in PI; “Will Never Be Administered to Humans in the Future”
January 6, 2020
- MHLW Panel Concerned about Further Clinical Trial for Eisai’s Investigational Epilepsy Drug Following Death
December 23, 2019
- After Death in First-in-Human Study, MHLW Needs to Release Info. to Alleviate Concerns about Participation in Studies
August 26, 2019
- Eisai Halts Epilepsy Drug Studies after Death in Japan PI
July 31, 2019
REGULATORY
- Nakai Tapped as MHLW’s Top Pharmacy Officer; Ohara to Steer Drug Pricing Reform
August 7, 2026
- Sarclisa SC, Joenja, Kineret, and 7 More Drugs Bound for NHI Listing
August 6, 2026
- Tepezza Price Cut Set at 5.5% under Japan’s CEA Scheme
August 6, 2026
- Dupixent Faces Fourth Re-Pricing under Japan’s SPA-SSS
August 6, 2026
- Chuikyo Clears NHI Listing for Oncolys’ Telomelysin
August 6, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…