Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Biogen/Eisai to Begin Aduhelm Confirmatory Study Next Year
Biogen and Eisai plan to launch a US FDA-mandated post-marketing confirmatory trial for their Alzheimer’s drug Aduhelm (aducanumab) next May, with its completion expected in around four years, the companies said on December 16. In their statement, the companies said…
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
- Aducanumab Gets Accelerated OK, Expert Says FDA Verdict Would Affect Japan Review Too
June 9, 2021
BUSINESS
- Trazenta Faces Multiple Patent Challenges Ahead of Anticipated Generic Entry
February 4, 2026
- Sawai Cedes to Merck in Januvia Row, Accepts Patent Scope
February 4, 2026
- Senju, Novartis Ink Promotion Tie-Up for Eye Drug Beovu in Japan
February 4, 2026
- Datroway Accepted for US Review for 1st-Line TNBC: Daiichi Sankyo
February 4, 2026
- Veozah Hits Primary Goal in Japan PIII Study: Astellas
February 4, 2026
Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…