Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.

Keeping a strategic focus but pivoting to meet health care priorities on demand were qualities Align Technology’s EMEA managing director Markus Sebastian ensured were uppermost at the company during the COVID-19 pandemic.

Israeli firm DreaMed has scored a new US Food and Drug Administration clearance for its AI-based diabetes decision support system Advisor Pro. The clearance enables physicians to use the software for patients with type 1 diabetes using continuous glucose monitoring (CGMs) and blood glucose meters (BGMs).

It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.