The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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 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
- Sanofi Bets on Immunotherapy to Delay Onset of Type 1 Diabetes
December 19, 2025
- Japan’s 1st Eylea Biosimilar to Reach Market on January 7
December 19, 2025
- Padcev-Keytruda Pair Makes Mark in Cisplatin-Eligible MIBC: Astellas
December 19, 2025
- Daiichi Sets February Launch for Japan’s 1st OTC Morning-After Pill
December 19, 2025
- Takeda’s TYK2 Inhibitor Scores PIII Win in Psoriasis Trials, Tops Otezla on Key Metrics
December 19, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…