Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Delays Review of Leqembi Iqlik for Alzheimer’s Initiation Therapy
The US FDA has extended by three months its review of the subcutaneous autoinjector formulation of Eisai’s anti-amyloid antibody Leqembi (lecanemab), as a once-weekly initiation therapy for early Alzheimer’s disease. The new target action date has been set for August…
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
- 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
- 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
- FDA Rolling Submission for Leqembi SC Completed: Eisai
November 5, 2024
- Eisai Begins Rolling Submission for Subcutaneous Leqembi in US
May 16, 2024
BUSINESS
- Former Takeda CEO Yasuchika Hasegawa Dies at 80
September 11, 2026
- Takeda R&D Chief Plump to Retire in June 2027
September 11, 2026
- Lasker Win “Not the Finish Line” for Chugai Researchers; Next-Gen Drug Advances
September 11, 2026
- Daiichi Sankyo Wins 203 Billion Yen Lawsuit over Fortis Bid
September 11, 2026
- Silchester Emerges as Suzuken’s Top Shareholder with 10.03% Voting Stake
September 11, 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…