Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
EMA Backs Leqembi after Re-Examination, but for Limited Use
The European Medicines Agency (EMA) has reversed its course on Eisai’s Alzheimer’s disease (AD) therapy Leqembi (lecanemab) and says it now recommends the drug’s approval, yet in a limited patient population. The EU regulator said on November 14 that its…
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
- Eisai Stands Firmly Behind Leqembi Profile despite EU Rejection
August 5, 2024
- EU Regulator Rejects Leqembi, Eisai to Seek Re-Examination
July 29, 2024
BUSINESS
- Halaven Generics Obtain Soft Tissue Sarcoma Use
September 3, 2026
- Ono Teams with Aitia in AI-Driven Neurology Drug Discovery
September 3, 2026
- Nippon Kayaku’s Generic Sunitinib Gains Pancreatic NET Use
September 3, 2026
- GSK Hit with MHLW Guidance over Sponsored Lecture
September 2, 2026
- Nonprescription Cialis Goes Nationwide in Japan, Now at 10,000 Outlets
September 2, 2026
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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…