Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- 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
- Kyowa Kirin Targets 20-Plus New Pipeline Assets by Early 2030s
February 10, 2026
- Kyowa Kirin’s FY2025 Core Operating Profit Hits Record High as Costs Fall
February 10, 2026
- Eisai CFO Casts Oncology Pipeline Expansion as Urgent Task
February 10, 2026
- Pharma Fears Off-Year Price Reform Loses Traction after LDP Sweep
February 10, 2026
- Chugai’s Hemlibra Successor Shows Promise in PI/II Study
February 10, 2026
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…