Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
BUSINESS
Eisai Halts Epilepsy Drug Studies after Death in Japan PI
Eisai said on July 30 that it has discontinued a Japan PI study for its next-generation AMPA receptor antagonist E2082 after a healthy volunteer subject died in June following its dosing. The drug’s PII program in the US has also…
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
- After Death in First-in-Human Study, MHLW Needs to Release Info. to Alleviate Concerns about Participation in Studies
August 26, 2019
BUSINESS
- Eylea Bio-AG to Carry DME Indication Missing from Fuji’s Biosimilar Label
December 5, 2025
- Forxiga Generics Launch in Japan at 33.6% of Originator Price: Sawai, T’s Pharma
December 5, 2025
- Vimpat Copies Hit Shelves at 35% of Originator Price as 10 Firms Flock to Market
December 5, 2025
- Keytruda Extends Japan Sales Lead to 26 Straight Months in November: Encise
December 5, 2025
- Meiji Pharma Takes Stake in Lyric Bio to Back Next-Gen IVIg Manufacturing
December 5, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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…