Two doctors have resigned from a prestigious panel after FDA approved a controversial Alzheimer's drug
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over the last eight months. In an interview Wednesday, he said he was baffled by the FDA's decision to approve the drug under a special mechanism known as an accelerated approval, which will require Biogen to confirm the drug works by running a follow-up trial.
"The FDA, in using the accelerated approval mechanism, they could not endorse any evidence of demonstrable clinical benefit. That's what their press release said in so many words. That seems illogical to me," he said. Perlmutter told STAT News that he resigned from the panel"due to this ruling by the FDA without further discussion with our advisory committee."
The FDA isn't required to follow the recommendation of its advisory committees, but typically does so.Was this article valuable for you? Read more: Business Insider »
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FDA Approves First New Alzheimer’s Drug in Nearly Two DecadesThe approval of the Biogen drug, which has the molecular name aducanumab and will be sold as Aduhelm, marked a watershed in Alzheimer’s drug research after billions of dollars in investment. but they forgot where they put it
FDA Approves 'Game Changer' Drug for Weight LossIn clinical trials, participants lost up to 15% of their body weight while taking the new drug, similar to results after weight-loss surgery. God, this would be so good. This would save the lives of millions of people, and change their lives for the better.
Explainer: What does FDA approval of Biogen's Alzheimer's drug mean for patients?The U.S. Food and Drug Administration has approved Biogen's aducanumab, the first drug to target an underlying cause of Alzheimer's disease. The drug, to be sold under the brand Aduhelm, is the first new approval of an Alzheimer's drug since 2003 and the only treatment designed to slow progression of the mind-robbing disease.
FDA approves Alzheimer's drug from Biogen, against experts' adviceThe approval comes after an independent panel to the FDA urged the agency to reject the drug, which will be sold under the name Aduhelm.
FDA Approves Controversial Alzheimer's DrugThe FDA has approved a controversial new drug for the treatment of Alzheimer's disease, ignoring the recommendation by its own advisory panel to reject it. $$$$$$ Noice So that means all Alzheimers patients will become human guinea pigs!
FDA Approval of New Alzheimer’s Drug May Boost Prospects of Other TreatmentsThe Food and Drug Administration’s approval of Biogen's Aduhelm on Monday may have boosted the prospects of other experimental Alzheimer’s disease drugs that target the disease in a similar way While we try to figure out why proteins misfold in Alzheimers, we're injecting ourselves with synthetic protein inducing transfection agents...sounds just peachy. More drugs that showed no functional impact. This will set AD research back years Fahaddurraniii A new breakthrough drug in Alzheimer’s after 2003, but efficacy yet to be established in phase 4 trials. Bhai billion dollars business hai Pharma.