Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
EU Regulator Rejects Leqembi, Eisai to Seek Re-Examination
Eisai said on July 26 that the European Medicines Agency (EMA) has recommended against approving its Alzheimer’s treatment Leqembi (lecanemab) - a setback that came despite a series of green lights picked up in other markets. The EMA’s Committee for…
To read the full story
Related Article
- Austria, Germany Become First EU Markets to Launch Leqembi
August 26, 2025
- Eisai’s Alzheimer’s Drug Leqembi Now Approved in Europe
April 16, 2025
- EMA Backs Leqembi after Re-Examination, but for Limited Use
November 15, 2024
- Eisai Stands Firmly Behind Leqembi Profile despite EU Rejection
August 5, 2024
- EMA Delays Decision on Leqembi Due to Procedural Issues
March 25, 2024
- Lecanemab Application Accepted for Review in Europe; FY2023 Approval Eyed
January 30, 2023
BUSINESS
- Fuji Plans July Launch for Japan’s 1st Simponi, Ranmark Biosimilars
May 21, 2026
- Myelofibrosis Med Inrebic to Go on Sale June 1: Recordati Japan
May 21, 2026
- Fujifilm Opens New US Facility, Expands iPSC-Derived Cell Production
May 21, 2026
- BMS, Nikon Pitch Japan-to-Asia Cell Therapy Push, Draw Support at Policy Forum
May 21, 2026
- High-Dose Uptravi Now Available: Nippon Shinyaku
May 21, 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…