Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Advisors Back Full Approval of Eisai’s Alzheimer’s Med
An advisory panel of the US FDA on June 9 unanimously recommended full approval of Eisai’s Alzheimer’s disease therapy Leqembi (lecanemab). The agency is set to deliver a decision by July 6, with a likely clearance expected to pave the…
To read the full story
Related Article
- Leqembi Likely to Face 15% Price Cut Under Special CEA Rule
July 10, 2025
- Eisai CEO Anticipates Leqembi Approval in Europe and China by March
December 18, 2023
- Leqembi to Cost 2.98 Million Yen per Year, Re-Pricing Might Be Triggered on Patient Upswing
December 14, 2023
- Leqembi to Debut on Dec. 20; Eisai Sees SC Version and Blood Biomarker as Drivers for Wider Use
December 14, 2023
- Leqembi OK’ed for Listing on Dec. 20; Peak Sales Put at 98.6 Billion Yen
December 13, 2023
- Chuikyo Agrees to Adopt Normal Rules to Price, Re-Price Leqembi
November 16, 2023
- Industry Prods Careful Debate on Creating Separate Rules for Leqembi Re-Pricing
November 9, 2023
- Medical, Long-Term Care Data Linkage Holds Key to CEA: Leqembi Debate
October 30, 2023
- Leqembi’s Initial Pricing Won’t Factor in Benefits in Long-Term Care
October 19, 2023
- Post-Launch Re-Pricing Likely the Focus of Chuikyo Leqembi Discussions
October 5, 2023
- As Chuikyo Begins Pricing Debate of Leqembi, Panelists Urge Safety, Fair Access
September 28, 2023
- Leqembi Subject to Cost Control Rule for Potential Big Sellers, MHLW Still Set to Meet Listing Deadline
September 26, 2023
- Japan Approves Eisai/Biogen’s Alzheimer’s Drug Leqembi
September 25, 2023
- Eisai’s Alzheimer’s Drug Clears Advisory Panel, Now in Line for Japan Approval
August 22, 2023
- Full US Nod in Hand, Eisai CEO Keeps 1 Trillion Yen Sales Target for FY2030
July 10, 2023
- FDA Awards Full Approval to Eisai’s Alzheimer’s Drug
July 7, 2023
BUSINESS
- Meiji Pharma Invests in Centivax to Support Vaccine R&D
March 31, 2026
- Takeda’s Zasocitinib Logs Positive Results in Global PIII Psoriasis Trials
March 31, 2026
- Ferring, Nippon Kayaku to Co-Promote Bladder Cancer Gene Therapy
March 31, 2026
- Mochida to Acquire Urece from Fuji Yakuhin for 13.5 Billion Yen
March 31, 2026
- Sumitomo Files Latuda for Pediatric Schizophrenia in Japan
March 31, 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…