Pear Picks Up Prescription Opioid App Clearance
Novartis subsidiary Sandoz will lead the US launch of Pear Therapeutics' reSET-O prescription-grade mobile app for opioid use disorder in the coming days following US FDA go-ahead.
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The new alliance is focused on developing a "digital therapeutic" for the treatment of depression. They hope it will take its place as an effective option among current drug and other cognitive therapies.
Finance Watch: Former Juno Execs Launch Sana With Allogeneic Cell Therapy Platform
Private Company Edition: Former Juno execs launch allogeneic cell therapy venture Sana, Atlas raises a $250m fund, and the Rakuten Aspyrian, Apollomics and Antengene VC deals exceed the $100m mark.
Opioid Use Disorder App Marks A Path For 510(k) 'Breakthrough' Devices
Pear Therapeutics announced US Expedited Access Pathway designation earlier this month for its 510(k)-route reSET-O Prescription Digital Therapeutic for OUD, perhaps providing some insight into the types of products seeking a "substantial equivalence" claim that might, nonetheless, be considered breakthroughs.