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...
Although generations of Americans have struggled with opioid addiction, what was once seen as a peripheral drug problem has lately hit the American public with force. Opioid overdoses have become so common that they are the number one cause of injury-related deaths in the United States, according to CDC reports. In 2015 alone opioids were involved in 33,091 deaths, according to the agency. The...
Boston- and San Francisco-based Pear Therapeutics, maker of a prescription digital therapeutic platform, announced today the closure of $50 million in Series B funding. The round was led by Singapore-based investment company Temasek, with participation from returning investors 5AM Ventures, Arboretum Ventures, and JAZZ Venture Partners, as well as new partners Novartis, EDBI, and the Bridge...
Pear Therapeutics announced today that reSET-O, a digital therapeutic for opioid use disorder, has received an Expedited Access Pathway (EAP) designation from the FDA. The EAP designation doesn't mean that the FDA has cleared the product, only that it has committed to fast-tracking it through the clearance process because of its timely public health value.
“The opioid epidemic continues to...
Just two months after announcing the applications for its pre-certification program pilot, the FDA has announced the nine companies that will be participating. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofaras...
In an FDA first, Boston- and San Francisco-based Pear Therapeutics' reSET system for the treatment of substance abuse has been granted a de novo clearance by the agency. It's the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease.
“This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey...
