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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 ....
Operator Good morning. My name is Qin, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen s Second Quarter Earnings Call and Financial Update. [Operator Instructions] Thank you. I would now like to turn the conference over to Mr. Mike Hencke, Director, Investor Relations. Mr. Hencke, you may begin your conference. Mike Hencke Director of Investor Relations Good morning, and welcome to Biogen s second quarter 2021 earnings call. Before we begin, I would encourage everyone to go to the Investors section of biogen.com to find the earnings release and related financial tables, including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today. ....
Biogen research chief says misinformation is cause for controversy surrounding newly approved Alzheimer s drug Dr Alfred Sandrock, head of research and development at Biogen, published a letter combatting misinformation surrounding its drug, Aduhelm He says that debate over whether the drug works is normal after FDA accelerated approval Cleveland Clinic and Mount Sinai both said they will not administer the controversial drug to patients Aduhelm received FDA approval last month despite little evidence that it worked in clinical trials Drug will cost an individual $56,000 for a year of treatment, and could cost Medicare as much as $29 billion a year ....