FDA, Biogen, and an Alzheimer’s drug approval: 8 key takeaways from congressional investigation

Congressional investigators sorted through more than 500,000 pages of documents from the Food and Drug Administration and Biogen to chronicle how a controversial Alzheimer’s disease drug was approved, and how it went from what was supposed to be the biggest drug launch in history to a financial catastrophe.

The resulting report is filled with fresh details about how one of the most storied biotech companies plotted with the federal agency that is supposed to regulate it, and how Biogen decided to set a price for the drug, Aduhelm, that fueled a public outcry.

The investigation by two House committees was in part spurred by STAT’s extensive reporting and turned up many new revelations, which are detailed in these stories about Biogen’s focus on maximizing profits and FDA “irregularities.”

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