Alzheimer’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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Health payers–including Medicare and Point32Health–to question Aduhelm pricing and its “reasonable and necessary” use

State’s Sec­ond-Largest Health Insur­er Slams Bio­gen For Cost­ly Alzheimer’s Drug (The Boston Globe): The state’s sec­ond-biggest health insur­er is threat­en­ing to lim­it or not cov­er Biogen’s new Alzheimer’s drug, accus­ing the Cam­bridge biotech of putting “exces­sive cor­po­rate prof­its” ahead of patients by charg­ing $56,000 a year for the con­tro­ver­sial treat­ment. Michael Sher­man, chief med­ical officer…

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Can the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer’s treatments? (Yes, it can)

The U.S. Food and Drug Admin­is­tra­tion (FDA) recent­ly approved adu­canum­ab, the first treat­ment that aims to slow the pro­gres­sion of Alzheimer’s dis­ease. But approval of the drug has pro­voked mixed reac­tions from the sci­en­tif­ic com­mu­ni­ty. Alzheimer’s dis­ease is char­ac­ter­ized by pro­gres­sive mem­o­ry loss, spa­tial dis­ori­en­ta­tion and many oth­er cog­ni­tive and behav­iour­al dis­or­ders that ulti­mate­ly lead…

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