Tuesday, February 9, 2021 Daily Archives

Biogen acknowledges risk on manufacturing provisions for aducanumab

Biogen says ‘significant capacity’ allocated to aducanumab could impact 2021 results if the potential Alzheimer’s disease treatment is not approved. At the end of last month, Biogen announced that the US Food and Drug Administration (FDA) would delay its decision on aducanumab by three months, meaning that a decision is now expected on approval by 7 June of this year. The monoclonal antibody (mAb) treatment could become the first therapy approved for Alzheimer’s disease to change the course of the…