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
- 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
- Otsuka to Acquire Transcend for US$700 Million, Snags PTSD Candidate
March 30, 2026
- Eisai, MSD File Lenvima-Welireg Combo in Japan for RCC
March 30, 2026
- Chugai CEO Takes Home 441 Million Yen in 2025: Securities Report
March 30, 2026
- Takeda to Resume MR Vaccine Shipments in June after Potency Issue
March 30, 2026
- Kyowa Kirin’s Mullick Earns 263 Million Yen in 2025; Workforce Down Sharply
March 30, 2026
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
Japan’s FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…
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…