Emily
Editor, Senior Moderator
They better clean house at the FDA quickly. Dr. Tom Friedan said on Twitter that the Defense Department is considering taking over the FDA. (Correction: I think that was actually the CDC discussed in the tweet, not the FDA - E)
https://finance.yahoo.com/news/bioge...113535546.html
Biogen says U.S. FTC, SEC probing Alzheimer's disease drug
Fri, February 4, 2022, 5:35 AM
(Reuters) - The U.S. Federal Trade Commission and the U.S. Securities and Exchange Commission have asked Biogen Inc to provide information on the approval and marketing of its new Alzheimer's disease treatment, Aduhelm, the drugmaker disclosed in a filing.
Biogen in its annual report on Thursday said it received a civil investigative demand, similar to a subpoena, from the FTC. The FTC is tasked with oversight of industry competition and consumer protection.
The SEC regulates securities markets and works to protect investors.
The U.S. Food and Drug Administration in June approved Biogen's Aduhelm - the first treatment for Alzheimer's in decades - despite one of its two large-scale clinical trials failing to show a benefit to patients. A panel of its expert advisers voted against the drug, and some panel members resigned.
In July, the FDA asked the Office of the Inspector General for the Department of Health and Human Services to open an investigation into interactions with Biogen related to the approval of the drug.
U.S. lawmakers have also launched an investigation into the drug...
https://finance.yahoo.com/news/bioge...113535546.html
Biogen says U.S. FTC, SEC probing Alzheimer's disease drug
Fri, February 4, 2022, 5:35 AM
(Reuters) - The U.S. Federal Trade Commission and the U.S. Securities and Exchange Commission have asked Biogen Inc to provide information on the approval and marketing of its new Alzheimer's disease treatment, Aduhelm, the drugmaker disclosed in a filing.
Biogen in its annual report on Thursday said it received a civil investigative demand, similar to a subpoena, from the FTC. The FTC is tasked with oversight of industry competition and consumer protection.
The SEC regulates securities markets and works to protect investors.
The U.S. Food and Drug Administration in June approved Biogen's Aduhelm - the first treatment for Alzheimer's in decades - despite one of its two large-scale clinical trials failing to show a benefit to patients. A panel of its expert advisers voted against the drug, and some panel members resigned.
In July, the FDA asked the Office of the Inspector General for the Department of Health and Human Services to open an investigation into interactions with Biogen related to the approval of the drug.
U.S. lawmakers have also launched an investigation into the drug...
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