Jul 29, 2021
Top researchers who advised the U.S. Food and Drug Administration on Biogen Inc.’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.”
The New England Journal of Medicine opinion piece, signed by seven members of an advisory panel that opposed clearing Biogen’s Aduhelm, is another sign of persistent furor over the agency’s decision. Two committees of the House of Representatives investigating the approval have asked the Cambridge, Massachusetts-based biotech to turn over documents about the drug’s development and approval.
Doctors and patients are desperate for new treatments for Alzheimer’s disease, which afflicts more than 5 million Americans. While many researchers have backed the FDA’s move, the drug hasn’t been shown to slow cognitive decline, as two big trials sponsored by Biogen yielded contradictory results. Three of the panel members resigned in
U S scientists clarify signing Science letter not in favor of lab-leak hypothesis - World News
sina.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from sina.com Daily Mail and Mail on Sunday newspapers.
From Olympic swimmer to pandemic responder
jhu.edu - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jhu.edu Daily Mail and Mail on Sunday newspapers.
The COVID Delta Variant Is Prompting the Return of Safety Protocols
eater.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from eater.com Daily Mail and Mail on Sunday newspapers.