Japan’s general trading houses are steadily becoming a force to be reckoned with in the pharmaceutical industry — and not…
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
- Nipro-Samsung Alliance Nears First Approval in Japan with Stelara Biosimilar
November 14, 2025
- Japan Panel to Review KalVista’s Oral HAE Drug, GSK’s Asthma Med, and More on Nov. 27
November 14, 2025
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- Industry Opposes Deeper CEA Price Cuts for “Cost-Increase” Products
November 13, 2025
- Pharma, Wholesalers Urge Drug Pricing Overhaul to Address Inflation: LDP Hearing
November 13, 2025
A public-private council report outlining industry views on Japan’s drug pricing systems drew little discussion at a meeting of the…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…
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…