Look back at pharma news in the week to June 11, 2021

By Barbara Obstoj-Cardwell. Editor

The US Food and Drug Administration last Monday finally approved the use of Biogen’s New Drug Application (NDA) for the use of aducanumab, now trade-named Aduhelm, for the treatment of Alzheimer’s disease. Novartis released positive Phase III data for its iptacopan as a treatment for a rare kidney disease. Last Wednesday, Ocugen revealed that, following a meeting with the FDA, it is seeking approval for its COVID-19 vaccine candidate, Covaxin, through a full Biological License Application (BLA), rather than the faster emergency use authorization process, suggesting that, with the number on vaccines already cleared for EUA, the agency is tightening up the rules. There was negative news from Vertex on Thursday, when the company announced that, although its rare disease candidate VX-864 met its primary endpoint in the latest trial, added to previous results it looks unlikely to provide substantial clinical benefit, so has dropped its development.

Big news with Aduhelm approval in Alzheimer’s