This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

After a year of R&D collaboration, Otsuka has made a decision to acquire Canadian venture Mindset to further expand its neurological pipeline with new 5-HT2A agonists.  

Vanda Pharmaceuticals contends the agency unfairly denied its request for fast track designation for tradipitant. This appears to be the first time the FDA has been sued over a denial. In FY 2021, CDER denied 78 requests for the designation and granted 173.