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.  

Japan’s annual drug reimbursement price revision for 2023 will cut approximately $2.3bn from national healthcare costs, and while several temporary price increases have been granted to cope with an ongoing supply crisis for some products, a system of one-off revisions for big sellers remains.

Public Company Edition: Aileron, Talaris and Frequency said they will reduce expenses and seek options for maximizing shareholder returns under tough stock market conditions. However, CureVac and Supernus are among firms recently able to access new cash – $250m and $150m, respectively.