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Mashup Score: 2Goodbye to Aduhelm - 3 month(s) ago
Word came this morning that Biogen is dropping their anti-amyloid antibody (Aduhelm, aducanumab), so it’s time to take stock. I was never happy about the FDA’s decision to approve it, and that’s putting it lightly. That was one of the worst decisions the agency has made in my 30+ years in the drug industry, as far as I’m concerned. I wasn’t alone in thinking that way, since some members of the advisory committee that recommended against that approval resigned in protest, and Medicare later declared that
Source: www.science.orgCategories: General Medicine News, Hem/OncsTweet
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Mashup Score: 3Years after a polarizing approval, Biogen walks away from Aduhelm - 3 month(s) ago
Biogen is giving up its ownership of Aduhelm, the Alzheimer’s disease treatment whose 2021 approval led to scrutiny and outrage.
Source: www.statnews.comCategories: General Medicine News, General HCPsTweet
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Mashup Score: 2
New data show the FDA’s rationale for approving drugs with unmet efficacy end points in pivotal trials has been inconsistent since at least 2018.
Source: HCP LiveCategories: General Medicine News, Latest HeadlinesTweet
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Mashup Score: 2FDA's Califf says congressional report on Aduhelm controversy contained 'no surprises' - 1 year(s) ago
FDA head Robert Califf made his first public comments following a congressional investigation into the agency’s role in approving Aduhelm.
Source: STATCategories: General Medicine News, Latest HeadlinesTweet
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Mashup Score: 1FDA's Califf says congressional report on Aduhelm controversy contained 'no surprises' - 1 year(s) ago
FDA head Robert Califf made his first public comments following a congressional investigation into the agency’s role in approving Aduhelm.
Source: STATCategories: General Medicine News, Latest HeadlinesTweet
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Mashup Score: 2
Eisai and Biogen will price their new Alzheimer’s treatment Leqembi at $26,500 per year, US CEO Ivan Cheung tells Endpoints News. With outcries over the pricing of the drugmakers’ previous drug, Aduhelm, all eyes are on the sticker price for the duo’s new treatment cleared by the FDA on Friday. Leqembi
Source: Endpoints NewsCategories: Expert Picks, Latest HeadlinesTweet
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Mashup Score: 2Seeking maximum profits, Biogen set an 'unjustifiably high price' for Alzheimer's treatment, investigation finds - 1 year(s) ago
The downfall of Aduhelm is largely the story of Biogen choosing to maximize its potential profits at the expense of patients and taxpayers, investigators found.
Source: STATCategories: General Medicine News, Latest HeadlinesTweet
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Mashup Score: 0In wake of House investigation, 5 burning questions for FDA, Biogen, and Alzheimer's treatments - 1 year(s) ago
Crucial questions remain for the Food and Drug Administration, Biogen, and the future of treating Alzheimer’s disease.
Source: STATCategories: General Medicine News, Latest HeadlinesTweet
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Mashup Score: 5‘Rife with irregularities’: Congressional investigation reveals FDA’s approval of Aduhelm marked by secret discussions, breaches of protocol - 1 year(s) ago
The FDA approval of Aduhelm included dozens of undisclosed calls and emails with Biogen and an “inappropriate” level of coordination with the company, investigators found.
Source: STATCategories: General Medicine News, Latest HeadlinesTweet
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Mashup Score: 0FDA, Biogen, and an Alzheimer's drug approval: 8 key takeaways from congressional investigation - 1 year(s) ago
Here are eight key takeaways from the congressional investigation of the FDA’s approval of the Biogen Alzheimer’s drug Aduhelm.
Source: STATCategories: General Medicine News, Latest HeadlinesTweet
RT @chrishendel: Goodbye to #Aduhelm -Derek Lowe @ScienceMagazine https://t.co/n9QwrSIPwA "I was never happy about FDA's decision to ap…