Biogen’s Alzheimer’s drug is unlikely to get EU approval.

Pharmaceutical manufacturer Biogen said on Wednesday The latest setback for a controversial drug since it was approved in the United States in June, when a drug review panel in the European Union said the new Alzheimer’s drug is unlikely to be approved there. Biogen said a committee of experts advising the European Medicines Agency issued …

Sales of Biogen’s expensive new Alzheimer’s drug lag far behind

Pharmaceutical manufacturer Biogen reported On Wednesday, the new Alzheimer’s drug, Aduhelm, brought in $300,000 from July to September, well below the company’s targets and Wall Street expectations. The sales figures Biogen announced in its third-quarter financial report, the drug’s first period of full availability, represented a rather slow start for a treatment that was promoted …

House Committees Request FDA Registrations for Alzheimer’s Drug Approval

Two powerful congressional committees investigating the controversial federal approval of Biogen’s Alzheimer’s drug Aduhelm requested extensive information and documentation from the Food and Drug Administration on Thursday, making it clear that committee leaders are dismayed by the unusual actions taken by the agency. evaluation and approval of the drug. “We are concerned about the apparent …

In Reversal, FDA Calls for Limits on Who Takes Alzheimer’s Drugs

Under fire for approving a questionable drug for all Alzheimer’s‘s patients, the Food and Drug Administration on Thursday largely narrowed down the previous recommendation and now recommends that only those with mild memory or thinking problems should take it. This turnaround, quite unusual for a drug that has only been on the market for a …