The FDA has officially cleared reSET-O — a digital therapeutic to treat opioid use disorder (OUD) jointly developed by Pear Therapeutics and Sandoz, a division of Novartis — a little over a year after it was granted an Expedited Access Pathway designation from the agency.
This announcement makes reSET-O the first digital therapeutic to treat patients with OUD. Patients will need a valid...
Novartis' recently-opened digital health innovation lab in San Francisco. Photo courtesy Novartis on Twitter.
Last month, Novartis announced that it would be cutting 2,200 jobs as part of a restructuring of the company focusing on particular priorities.
“The overall strategy we have is to focus the company as a leading medicines company powered by digital technologies,” CEO Vas Narasimhan told STAT News last month. “What that has meant is to exit certain health care sectors or segments … — so we exited...
reSET — a substance use disorder treatment that was the first software-only therapeutic cleared by the FDA — is now commercially available for clinicians to prescribe to their patients, according to a release from Pear Therapeutics and Sandoz, a division of Novartis with which Pear partnered back in April.
But while physical prescription drugs are usually handled through a pharmacy, the process...
The digital health landscape, from the Digital Therapeutics Alliance's new report.
The precise definition of digital therapeutics has been a hot topic as the new technology category has been discussed and debated in event sessions and articles over the last few years. Now the Digital Therapeutics Alliance, a consortium of industry stakeholders, is hoping to put that to rest with an official definition, released this week in a whitepaper.
The definition reads as follows:
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(L to R) Moderator Scott Thiel, Pear Therapeutics' Dan Amor, Verily's Afia Asamoah, Tidepool's Howard Look, and Johnson & Johnson's Eduardo Sanchez (photo by Jonah Comstock)
Attendees to the Connected Health Conference in Boston this week got a sneak peek into the workings of the FDA's much-discussed Pre-Cert program. In a panel discussion at the event, representatives from Verily, Pear Therapeutics, Tidepool, and Johnson & Johnson candidly discussed their experiences so far with the program, describing an evolving process that is collaborative and rigorous.
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As digital therapeutics move to cross boundaries of regulatory approval and efficacy data, the healthcare industry will begin to move to a bifurcated world of digital health apps in the same way that drugs are now divided up into largely unregulated supplements and heavily regulated pharmaceuticals.
At the Digital Health Innovation Summit last week in Boston, Sanofi Ventures Senior Director of...
A drug no longer needs to be a tangible object, according to panelist at the BIO 2018 convention in Boston. The way the pharma industry looks at medication is evolving and may be including new tech-focused treatments, such as digital therapeutics.
“If you think about the trajectory of medicine what is a drug these days: is it a pill, is it an injection, is it infusion, is it gene therapy? We’ve...
From syringes to workflow management systems, healthcare is no stranger to adopting new technologies into standard care. As digital and connected technologies continue to stake their claim in the industry, the last few years have seen the rise of a new type of health technology product — one that promises measurable health outcomes validated by traditional clinical trials.
“You had a little...
Pear Therapeutics has inked a deal with pharma company Novartis to work together on the development of two digital therapeutics for multiple sclerosis and schizophrenia. It’s the first time a pharma company has made a development deal with a digital therapeutic, according to Pear.
“We have been in discussions for many months now with the [Novartis Institutes for BioMedical Research] group at...
Sanofi has found yet another partner to help digitize its clinical trial processes. In a statement, TriNetX announced that it will be assisting the pharmaceutical company by using patient EHRs to optimize recruitment, streamline trial investigators’ workflows, and otherwise impact the design of investigational drug trials. Sanofi has made similar arrangements to bolster its clinical trials with...
