It slid 3% on Friday after STAT’s report that the US Food and Drug Administration’s deputy director was requesting a federal investigation into approval for treatment of Alzheimer’s disease. A month after the decision frustrated lawmakers, doctors and public health. He defended members of the Independent Committee related to the FDA and led them to resign. In a letter, Deputy Commissioner Janet Woodcock requested the Inspector General’s Office to investigate the interaction between FDA staff and Biogen for approval of the drug Aduhelm. STAT was reported. Authorities cited a report by STAT that FDA authorities would work closely with Biogen to bring the drug to market. “Concerns continue to be raised regarding the contact between Biogen and FDA representatives during the review process, including those that may have occurred outside the formal communications process,” Woodcock said. I wrote in a letter to Grim. On Thursday, Biogen announced an updated label for Aduhelm. This limits the target patients to patients with “mild cognitive impairment or stage of mild dementia” rather than the broader group diagnosed with dementia. Those who have been studied in clinical trials. The FDA has been criticized for approving Biogen for Aduhelm, which is considered suspicious clinical data, and for pricing the drug for $ 56,000 for one year of treatment.Biogen’s share has increased 47% year-to-date, but SPDR S & P Biotechnology ETFs
5% down, S & P 500
Increased by 15%.
Biogen’s stock falls under the FDA’s head report seeking an investigation into her institutional approval of Alzheimer’s disease drugs
Source link Biogen’s stock falls under the FDA’s head report seeking an investigation into her institutional approval of Alzheimer’s disease drugs