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FDA releases Biogen Alzheimer's disease new drug review memorandum

 Last Update: 2021-08-16
 Source: Internet
 Author: User

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The FDA recently announced the review of Biogen's new Alzheimer's disease drug Aduhelm (aducanumab) series of documents

Three of the memos totaled 83 pages, revealing the unprecedented internal review process as of June 7th, showing how institutional reviewers dealt with conflicting data about the drug, and ultimately objected to one of the three review teams and Under the previous opposition of the FDA advisory committee, the agency chose conditional approval

According to the data, CDER Director Patrizia Cavazzoni and Director of the Office of New Drugs Peter Stein both agreed with the accelerated approval proposed by Billy Dunn, head of FDA neuroscience, while the staff of the FDA Office of Biostatistics believed that approval was unnecessary

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