Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
BUSINESS
FDA Accepts Leqembi SC for Review; Target Date Set to Aug. 31
Eisai said on January 14 that the US FDA has accepted for regulatory review its application for a subcutaneous autoinjector version of Leqembi (lecanemab) as a weekly maintenance treatment for early Alzheimer’s disease. The target action date under the Prescription…
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 Rolling Submission for Leqembi SC Completed: Eisai
November 5, 2024
- Eisai Begins Rolling Submission for Subcutaneous Leqembi in US
May 16, 2024
BUSINESS
- AG Price Parity Plan Stokes Industry Fears of Patient, Pharmacy Defections
December 12, 2025
- Kyowa Kirin Names Abdul Mullick as Next CEO from March 2026
December 12, 2025
- Regeneron Files Libtayo for Squamous Cell Carcinoma in Japan
December 12, 2025
- Chugai to Donate 100 Million Yen to Support Nobel Laureate Sakaguchi’s Research
December 12, 2025
- Regeneron Lines Up 5 Late-Stage Assets for Japan: Commercial Head
December 11, 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…