Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Rolling Submission for Leqembi SC Completed: Eisai
Eisai said on November 1 that it has completed the rolling submission of its biologics license application to the US FDA for a subcutaneous autoinjector version of Leqembi (lecanemab) as a weekly maintenance treatment for early Alzheimer’s disease. The product…
To read the full story
Related Article
- 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
- Leqembi Iqlik Autoinjector Now Available in US: Eisai/Biogen
October 8, 2025
- Eisai Begins FDA Rolling Submission for Leqembi SC for Starting Dose
September 4, 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
- Eisai Begins Rolling Submission for Subcutaneous Leqembi in US
May 16, 2024
BUSINESS
- Takeda CEO Says Orzeyful Could Redefine NT1 Standard of Care
July 31, 2026
- Pfizer Seeks Pediatric Expansion for Hympavzi in Japan
July 31, 2026
- Nippon Shinyaku Exercises Option for AB2 Bio’s Tadekinig Alfa in US
July 31, 2026
- Alfresa Takes Stake in Ember to Bolster Pharma Cold Chain in Japan
July 31, 2026
- Sanwa Kagaku Says Kumamoto Plant Remains Shut, Drug Supplies Stable
July 31, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
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…