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Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.
It’s not really a novel idea, requiring a drug to prove a benefit to patients before being covered by Medicare. But in Alzheimer’s disease, it’s been a massive debate.
The Freedom of Information Act (FOIA) request seeks materials regarding cost considerations, the FDA’s Accelerated Approval Program, and potential harm to...
Although Medicare has agreed to pay for Aduhelm, its coverage comes with restrictions.
Of the new cases, 1,318 were locally transmitted, the National Health Commission said, compared with 1,334 on April 8. Italy reports 53,253 coronavirus cases, 90 deaths on Sunday Italy reported 53,253 COVID-19 related cases on Sunday, down from 63,992 the day before, the health ministry said, while the number of deaths fell to 90 from 112.