Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Eisai Begins Rolling Submission for Subcutaneous Leqembi in US
Eisai has initiated the rolling submission for a subcutaneous autoinjector version of its Alzheimer's disease treatment Leqembi (lecanemab) to the US FDA following fast-track designation granted by the agency, the company said on May 15. The subcutaneous version of the…
To read the full story
Related Article
- 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
- FDA Rolling Submission for Leqembi SC Completed: Eisai
November 5, 2024
- Leqembi’s Monthly IV Dosing Accepted for FDA Review: Eisai
June 11, 2024
BUSINESS
- Pfizer, ASKA to Co-Promote RSV Vaccine Abrysvo in Japan
March 9, 2026
- Sumitomo to Launch Post-Marketing Study for iPSC Therapy by Year-End
March 9, 2026
- Drug Pricing Reform Draws Sharp Industry Backlash in Jiho Poll
March 9, 2026
- Nitrosamine Detected in Nichi-Iko’s Tryptanol, No Need to Halt Prescriptions
March 9, 2026
- Towa Broadens Label for Tacrolimus in Cell Transplantation
March 9, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…