During Q3, biopharma merger and acquisition value reached $15.4bn and drew in $37.6bn in potential deal value from alliances. Device company M&A values reached $550m, while in vitro diagnostic firms and research tools players completed M&A activity that totaled $1.9bn.

The US biotech has released new positive data from two late-stage studies in the rare disease after the US FDA asked for more controlled data following an initial disappointment.

COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.

Complications in analysis due to the impact of COVID on trial conduct are a common factor in two recent negative advisory committee reviews, but it is safe to say that both applications were rejected primarily for other reasons. When will COVID issues be decisive for FDA?