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
- Daiichi Targets 3 Trillion Yen Sales by FY2030, Global Top-5 Oncology Spot
May 12, 2026
- Lilly Japan Hits Record Sales as Mounjaro Tops 100 Billion Yen
May 12, 2026
- Ferring Nabs Japan Approval for Bladder Cancer Gene Therapy
May 12, 2026
- Teijin to Offload Legacy Drug Portfolio as It Speeds Up Pivot to Rare Diseases
May 12, 2026
- Keytruda Extends Run as Japan’s Best-Selling Drug in April: Encise
May 12, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…