Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Delays Decision for Biogen’s Aducanumab to June 7
The US FDA has extended the review period for Biogen’s controversial Alzheimer’s drug aducanumab by three months to June 7, the big biotech and its partner Eisai said in a brief statement on January 29. Aducanumab is under priority review…
To read the full story
Related Article
- CMS Decision De-Facto Denial of All Medicare Patient Access to Aduhelm: Biogen
April 11, 2022
- Aduhelm Deal Revised, Eisai Poised to Sharpen Focus on Lecanemab: CEO
March 17, 2022
- Biogen/Eisai Alzheimer’s Pact Amended to Switch Aducanumab Collab to Royalty Scheme
March 16, 2022
- Eisai Formally Opposes CMS Coverage Proposal for Aduhelm
February 14, 2022
- Eisai “Strongly Opposes” Medicare Coverage Proposal for Aduhelm, Calls for Revisit
January 14, 2022
- Japan Seeks Additional Study for Aducanumab, Next Review Might Be Few Years Off
December 23, 2021
- Biogen Halves US Price Tag on Aduhelm to Improve Patient Access
December 21, 2021
- FDA Updates Aduhelm Label to Only Cover MCI, Mild Alzheimer’s
July 9, 2021
- Eisai CEO Says Aducanumab Price Tag Reflects Its Value, 1 Million Patients Estimated in Japan
June 10, 2021
- Aducanumab Gets Accelerated OK, Expert Says FDA Verdict Would Affect Japan Review Too
June 9, 2021
- FDA Approves Aducanumab, 1st Disease-Modifying Therapy for Alzheimer’s
June 8, 2021
- Potential Reimbursement Challenges of Aducanumab Could Usher in Health Insurance Overhaul in Japan
January 8, 2021
- Aducanumab Submitted in Japan, but Decision Unlikely to Come Until Next Autumn
December 11, 2020
- Biogen Files Japan NDA for Aducanumab
December 10, 2020
- Expert Panel Delivers Harsh Verdict on Aducanumab, FDA Decision Due by March 7
November 9, 2020
BUSINESS
- Rising Costs Squeeze Generic Firms, Spur Calls for Unprofitable Drug Re-Pricing in 2027
April 8, 2026
- BMS Files to Fully Localize Breyanzi Production in Japan
April 8, 2026
- Japan Ethical Drug Sales Surge 7.7% in February: Crecon
April 8, 2026
- Sanofi to Launch Voluntary Buyout Program, Targets General Medicines Unit
April 7, 2026
- Toho’s VC Arm Makes First Investment in US AI Antibody Startup
April 7, 2026
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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 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…