Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Eisai Begins FDA Rolling Submission for Leqembi SC for Starting Dose
Eisai has begun a rolling submission to the US FDA seeking approval for the use of a subcutaneous autoinjector version of Leqembi (lecanemab) as a once-weekly dosing option beginning from the initiation phase of treatment. The filing is being made…
To read the full story
Related Article
- Leqembi Iqlik Now Available for Alzheimer’s Initiation Use in US
August 25, 2026
- FDA Greenlights Leqembi Iqlik for Alzheimer’s Initiation Therapy
July 14, 2026
- FDA Delays Review of Leqembi Iqlik for Alzheimer’s Initiation Therapy
May 11, 2026
- Leqembi Iqlik Now under FDA Review for Initiation Phase
January 26, 2026
- Rolling Submission for Leqembi SC Starting Dose Completed in US
November 27, 2025
- Leqembi Iqlik Autoinjector Now Available in US: Eisai/Biogen
October 8, 2025
- FDA Clears Leqembi Autoinjector; Launch Set for Oct. 6
September 2, 2025
- FDA Accepts Leqembi SC for Review; Target Date Set to Aug. 31
January 15, 2025
- FDA Rolling Submission for Leqembi SC Completed: Eisai
November 5, 2024
- Eisai Begins Rolling Submission for Subcutaneous Leqembi in US
May 16, 2024
BUSINESS
- Ex-Takeda CEO Weber Joins Rakuten Medical as Vice Chairman
September 10, 2026
- 3 Chugai Researchers Win Lasker Award for Hemlibra Discovery
September 10, 2026
- Elix, Axcelead DDP Forge Pact on Novel Protein Degraders
September 10, 2026
- CMIC Scraps Application Forms, Brings AI Avatars into New Grad Hiring
September 10, 2026
- Teijin, Shinshu University Link Arms on CAR-T Manufacturing
September 10, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
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…
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…