Otsuka/Click’s global-first adjunctive digital therapy for depression marks another step by pharmaceutical firms going digital for psychotherapy through collaborations.

The lower benefit in the olmesartan arm of KARDIA-2 could draw scrutiny, but the company said it was expected and noted polypharmacy is common in hypertension.

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. 

Seven novel agents approved in March include one accelerated approval, two rare pediatric disease priority review vouchers, two breakthrough therapy designations and one regenerative medicine advance therapy designation.