Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
REGULATORY
Aricept’s Lewy Body Dementia Indication to Be Modified after Post-Launch Trial Miss
For the first time in more than 14 years, the Japanese health ministry is requiring a partial change of approval under its pharmaceutical reexamination system. Eisai’s Aricept (donepezil) now braces for such modification process, which also entails a label revision,…
To read the full story
Related Article
- Lewy Body Dementia Specialist Sees Aricept Approval Modification as Positive Move
December 6, 2022
- Aricept Label Now Modified for Lewy Body Dementia Indication: Eisai
November 30, 2022
- Aricept Generics Earn Lewy Body Dementia Indications
March 14, 2019
- MHLW Approves Additional Indications for Aricept, 2 Other Drugs
September 22, 2014
REGULATORY
- LDP Leans Towards “Special Charges” for OTC-Like Drugs, Not Coverage Removal
December 15, 2025
- Ishin Urges “Special Charge” Scheme for OTC-Like Drugs, Eyes FY2026 Launch
December 15, 2025
- Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests
December 15, 2025
- LDP Tax Panel OKs New 40% R&D Credit for Strategic Technologies
December 12, 2025
- Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
December 11, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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…
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…