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Latest From Eisai Co., Ltd.

Lilly’s ‘High Quality’ Donanemab Data Supports Unrestricted Medicare Coverage, Firm Says

As FDA decision on Alzheimer’s product approaches, new paper outlines Lilly’s arguments for unfettered Medicare coverage for donanemab once it is approved.

Reimbursement Policy

Orphan Drug, Domestic Developers Shine In China Annual Approvals Tally

10 orphan drugs imported from overseas, and 40 new drug approvals, including many from domestic developers, capped 2023 as one of the busiest years for China's drug regulatory agency, as Beijing pivoted to emphasizing affordable innovation and expanding access to newer therapies for rare conditions.

China Approvals

Aduhelm’s Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH

Pulling the controversial Alzheimer’s drug’s BLA should not exempt Biogen from fulfilling ClinicalTrials.gov reporting requirements for two key studies, even if the research gets terminated, former head of the NIH data repository tells the Pink Sheet.

United States Clinical Trials

AbbVie Stays On Script With Michael As Next CEO

As previously indicated, AbbVie will go with an internal candidate, president and COO Robert Michael, to succeed Richard Gonzalez as CEO. The company has recently positioned Michael prominently.

Executive Changes Leadership
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