REGULATORY
MHLW Panel Concerned about Further Clinical Trial for Eisai’s Investigational Epilepsy Drug Following Death
The Ministry of Health, Labor and Welfare (MHLW) reported on December 19 results of an investigation into the death of a man who received Eisai’s experimental epilepsy medicine in a PI trial in Japan at a meeting of the Pharmaceutical…
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
- Causal Link between Eisai’s Epilepsy Drug and Trial Death Can’t Be Ruled Out: MHLW
December 2, 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
- Japan Officially Eases Trial Recruitment Rules; Industry Welcomes Move
April 1, 2026
- MHLW Updates Q&A on Use of Registry Data in Drug Applications
April 1, 2026
- Japan Panel Designates Two Ebola Therapies for Early Approval Pathway
April 1, 2026
- MHLW, METI Launch Joint Task Force to Safeguard Medical Supply Chains
April 1, 2026
- Japan Urges Priority Supply of Petroleum-Based Materials for Medical Devices
March 31, 2026
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…





