FDA Investigation Unlikely to Influence Biogen's (BIIB) Aduhelm Uptake - Analyst

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Go back to FDA Investigation Unlikely to Influence Biogen's (BIIB) Aduhelm Uptake - Analyst

FDA seeks probe into its talks with Biogen before Alzheimer's drug approval

July 9, 2021 2:37 PM EDT

By Manas Mishra

(Reuters) - The U.S. Food and Drug Administration on Friday called for an independent federal probe into its representatives' interactions with Biogen Inc that led to approval of the company's Alzheimer's disease drug last month.

The drugmaker's shares closed down 3% after the agency's acting commissioner Janet Woodcock asked the Office of the Inspector General at the Department of Health and Human Services to probe if the talks were inconsistent with the regulator's policies.

"We received the letter and are reviewing it for appropriate action," Tesia Williams, a spokesperson of HHS's Office of the... More

Biogen (BIIB) Shares Down 4% As Head of FDA Calls for a Federal Investigation into Approval of Aduhelm

July 9, 2021 1:36 PM EDT

Biogen (NASDAQ: BIIB) shares are trading 4% lower following a call by the head of the FDA to investigate the infamous Alzheimers drugs approval process.

In an open letter posted on Twitter on Friday, Dr. Janet Woodstock, Acting Commissioner of the FDA,... More

FDA calls for federal investigation into its controversial Alzheimer's drug approval - STAT

July 9, 2021 12:53 PM EDT

FDA calls for federal investigation into its controversial Alzheimers drug approval - STAT

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Biogen (NASDAQ: BIIB)

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