The week in pharma: action, reaction and insight – week to August 26

By Barbara Obstoj-Cardwell. Managing editor

On the regulatory front last week, the long-awaited approval of Axsome Therapeutics’ Auvelity from the US Food and Drug Administration finally came through, clearing the drug for the treatment of major depressive disorder (MDD). Also, Foghorn Therapeutics announced that it has received a full clinical hold from the FDA regarding its Phase I trial of leukemia drug candidate FHD-286. And, Swiss drug developer Pharvaris last Monday revealed it had been notified of an FDA clinical hold on its PHA121 trial in hereditary angioedema. In the M&A space, a merger of eye care specialists is forthcoming, with last week’s announcement that Alcon has agreed to acquire Aerie Pharmaceuticals. Also of note, last Thursday Pfizer released positive new data on its respiratory syncytial virus (RSV) candidate RSVpreF.

Axsome’s Auvelity will experience strong uptake globally by 2029