Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
COMMENTARY
After Death in First-in-Human Study, MHLW Needs to Release Info. to Alleviate Concerns about Participation in Studies
An adult man who completed the administration of an investigational drug in a Japan PI study conducted by Eisai has died. Whether there was a causal relationship between the drug and the subject’s death remains unclear at the present time,…
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
- Causal Link between Eisai’s Epilepsy Drug and Trial Death Can’t Be Ruled Out: MHLW
December 2, 2019
- Eisai Halts Epilepsy Drug Studies after Death in Japan PI
July 31, 2019
COMMENTARY
- Is Calling for an Abolition the Right Play? Rethinking Japan’s FY2027 Off-Year Drug Price Revision
February 9, 2026
- Japan’s Biological Raw Material Rules Enter Major Revision; Clarity on Benefits and Safety Holds Key
February 5, 2026
- TSE’s Growth Market Reform Puts Pressure on Biotechs
January 27, 2026
- Wave of “World Firsts” Looms as 47 New Drug Candidates Line Up for 2026
January 6, 2026
- Radioligand Therapy Faces Capacity Bottleneck in Japan, System Build-Out Needed to Deliver on Promise
December 22, 2025
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…