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
- BMS, Nikon Eye Full Domestic CAR-T Manufacturing in Japan from 2027
March 19, 2026
- Blenrep, Monjuvi, Zynyz, and More New Drugs Hit Japan Market
March 19, 2026
- Celltrion, CMIC Forge Broad Partnership in Japan Biosimilars Business
March 19, 2026
- Nipro’s Generic Radicut Gains ALS Nod, Aligning with Originator
March 19, 2026
- Gilead’s Japan Revenue Up 15% in 2025 as Trodelvy Gains Traction
March 19, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…