Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
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
- Fuji Pharma Recalls Eylea Biosimilar Lots over Faulty Finger Grips
November 6, 2026
- Medipal Sets Dec. 15 Shareholder Meeting, Opposes Chairman’s Ouster
November 6, 2026
- Nitrosamine Impurities Reported for Generic Telmisartan; No Recalls Planned
November 6, 2026
- Bracco Japan to Acquire Iopamiron from Bayer in July 2027
November 6, 2026
- Astellas on Track to Hit 30% Margin Goal Early after Strong H1 Scorecards
November 5, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…