News Commentary | February 23, 2021
EtectRx's partnership with Pear Therapeutics shows renewed promise for smart pill augmentation‑type digital therapeutics after Proteus' end last year. While Proteus had potential – evidenced by Otsuka's acquisition of the technology post‑bankruptcy – the technology's deployment was doomed from the ... Not part of subscription
News Commentary | July 30, 2021
Google‑backed Calico and pharma giant AbbVie are doubling down on tackling aging‑related diseases with this second partnership extension. Twenty early‑stage programs have been developed across oncology and neurodegeneration, with the lead oncology target, which acts at multiple steps in the cancer ... Not part of subscription
Company Profile | December 01, 2021
Regulus Therapeutics was created as a joint venture between Alnylam Pharmaceuticals, an RNAi therapeutics company, and Isis Pharmaceuticals (now known as Ionis Pharmaceuticals), a company focused on anti‑sense technologies and therapeutics, in 2007 Regulus Therapeutics is focused on the ... Not part of subscription
by Danielle Bradnan
The key thing about this development is that Pear Therapeutics submitted to the FDA for approval via two separate pathways – the precertification pathway, and the more traditional 510(k) pathway. The precertification pathway was expected because digitial therapeutics are the reason that it exists, but by leveraging the 510(k) pathway, Pear is legitimizing the technology not only as part of a special process but as part of the broader approval landscape. Using the 510(k) pathway successfully opens the door for other digital therapeutics and is a turning point in the approval process for digital therapeutics overall. Clients should be engaging with this fast-moving space as it rapidly gains legitimacy in the healthcare ecosystem.
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