Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Lilly’s Alzheimer’s Med Donanemab Now in Line for Japan Approval
Eli Lilly’s Alzheimer’s drug donanemab sailed through the review of a key health ministry panel on August 1, setting the stage for its approval as the second anti-amyloid β (Aβ) antibody to treat the memory-robbing disease in Japan, after Leqembi…
To read the full story
Related Article
- Japan Approves Lilly’s Kisunla, Eisai’s ALS Med, Gilead’s Trodelvy, and Lots More
September 25, 2024
- Japan Approves Label Expansions for Alecensa, Nucala and More
August 29, 2024
- As Kisunla Approval Nears, Japanese Alzheimer’s KOL Hails Increase in Options
August 9, 2024
- Lilly’s Alzheimer’s Therapy Filed in Japan, Approval Eyed in 2024
September 27, 2023
REGULATORY
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
- LDP Study Group’s Honebuto Proposal Urges “Freeze” on On-Patent Drug Price Cuts
May 20, 2026
- PMDA Flags Iron Products, ST Combination Drug in Risk Review
May 20, 2026
- MHLW Orders Detailed Report on Tavneos Efficacy Concerns
May 20, 2026
- Japan Approves Jascayd, mNEXSPIKE, Zepbound OSA Use, Others
May 19, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…