For Biogen, an expensive gamble has paid off, as even with accelerated approval the company stands to make billions of dollars from aducanumab, given it estimates there are around 1.5 million ...

Biogen filed aducanumab with the FDA in July last year and the regulator granted a faster six-month Priority Review in August lasty year. With the extension the FDA is now due to make a decision ...

Biogen said on Wednesday it would discontinue developing and commercializing Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use and terminate the ENVISION clinical study.

Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...

The Sarepta and Biogen therapies mentioned are, respectively, Exondys 51 (eteplirsen) and Aduhelm (aducanumab). They are used for Duchenne muscular dystrophy and Alzheimer's disease. The FDA's ...

For some observers, the failures cast doubt on the longstanding idea that the culprit in Alzheimer’s is amyloid plaques in the brain, given that Biogen’s drug, aducanumab, and other candidates had ...

In 2023, the FDA withdrew its approval of HPC after a years-long battle. In 2024, Biogen stopped selling aducanumab. The FDA's accelerated approval program was designed to speed the development ...

America’s Food and Drug Administration (FDA) had just approved Biogen’s Aducanumab, the first drug for Alzheimer’s disease to be admitted to the market for 18 years. The US Alzheimer’s ...

If approved, Biogen’s aducanumab would be the first treatment designed to delay progression of the fatal, memory-robbing disease. The drug has had a tumultuous journey, with promising early data ...

“But this is the most striking effect so far.” Aducanumab, developed by Cambridge, Massachusetts–based Biogen, was discovered in a screen of human memory B cells that produce antibodies capable of ...