Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Rolling Submission for Leqembi SC Starting Dose Completed in US
Eisai said on November 26 that it has completed its rolling submission to the US FDA for Leqembi Iqlik, the subcutaneous autoinjector formulation of lecanemab, as an option for once-weekly initiation-phase dosing.The submission was carried out under the FDA’s Fast…
To read the full story
Related Article
- FDA Delays Review of Leqembi Iqlik for Alzheimer’s Initiation Therapy
May 11, 2026
- Leqembi Iqlik Now under FDA Review for Initiation Phase
January 26, 2026
- Eisai Begins FDA Rolling Submission for Leqembi SC for Starting Dose
September 4, 2025
BUSINESS
- Takeda Hands CEO Baton to Kim after 12-Year Weber Era
June 25, 2026
- Tanabe Starts Long-Term Uplizna Study in IgG4-Related Disease
June 25, 2026
- ASKA Shareholders Back Faster Poison Pill Activation
June 25, 2026
- EU Approves Padcev-Keytruda for Earlier Bladder Cancer Use
June 25, 2026
- Tacrolimus Generics Add Cell Transplantation Indication
June 25, 2026
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
Recent trends are creating a fascinating push-and-pull effect in the talent market. We’re seeing more positions opening up, but also a greater number of candidates available, particularly in the fields of rare diseases and oncology. This “more positions, more candidates”…
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…