Posts Tagged ‘Biogen’
Growing controversy over role of FDA and Medicare in promoting anti-amyloid drugs given limited benefit, high cost, severe side-effects
The War Over Whether Medicare Should Pay For The New Anti-Alzheimer’s Drugs (Forbes): The powerful Alzheimer’s Disease lobby is fighting a multi-billion-dollar battle on two fronts. It is quietly trying to limit restrictions the Food and Drug Administration puts on the use of new drugs aimed at slowing the progression of the brain disease. And…
Read MoreAmyloid-related imaging abnormalities (ARIA) found in approximately 40% of patients taking “Alzheimer’s drug” Aduhelm
Study: Biogen’s Aduhelm Caused Brain Swelling in Over One-Third of Study Participants (BioSpace): Attention is being focused on a side effect of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab). Even before its controversial approval on June 7, there were cases of amyloid-related imaging abnormalities (ARIA‑E), or cerebral edema, observed in the trials.
Read MoreStudy: Fewer than 1% of geriatric patients with cognitive complaints met Aduhelm research trial criteria. What can we expect about its real-world safety?
Biogen’s Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises (Fierce Pharma): While the chatter surrounding Biogen’s controversial Alzheimer’s med Aduhelm has largely been centered on a pivotal Medicare reimbursement decision as of late, analysts are pointing to one new study that suggests there may be “room for surprises” when…
Read MoreOn cognitive reframing and biases, stress, mental health tech, Aduhelm backlash, Britney Spears, and more
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring this time nine scientific reports and industry developments to help promote lifelong brain and mental health. #1. To lower stress levels and improve problem-solving, practice cognitive reframing instead of venting “… venting likely doesn’t soothe anger as much as augment it. That’s because encouraging people to…
Read MoreVeterans Affairs won’t cover Biogen’s new “Alzheimer’s drug” given concerns over safety and lack of evidence
VA Health System Won’t Cover Biogen’s Alzheimer’s Drug (The Wall Street Journal): The Department of Veterans Affairs won’t cover Biogen Inc.’s new Alzheimer’s drug, the latest rebuke of the controversial treatment since it was approved earlier this summer. The VA decided not add the drug, called Aduhelm, to its formulary list of available medicines because…
Read MoreAlzheimer’s & Dementia researchers challenge FDA’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker
Doctors Blast Biogen Alzheimer Approval as ‘Regulatory Failure’ (Bloomberg): 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.”
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