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Biogen pulls Alzheimer's drug application in Europe as EMA calls data insufficient

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.
Priya Singhal Centers For Medicare Committee For Medicinal Products Human European Medicines Agency Medicaid Services Biogen Alzheimer

Health News Roundup: Italy reports 53,253 coronavirus cases, 90 deaths on Sunday ; India's COVID-19 vaccine prices cut as booster program is extended and more

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.
United States United Kingdom Adar Poonawalla Eli Lilly Centers For Medicare Eisai Co Ltd

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Final CMS decision limits coverage of Biogen's Aduhelm to those in clinical trials

Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.
United Kingdom United States Lee Fleisher Centers For Medicare Medicaid Services Biogen Alzheimer

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