Pharma

By Dave Muoio November 20, 2018
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...
NovioSense's artist conception of its device in use.

NovioSense's artist conception of its device in use.

By Jonah Comstock November 20, 2018
Last week, Alphabet subsidiary Verily Life Sciences announced the end, at least for the foreseeable future, of its glucose-sensing contact lens collaboration with Novartis. Verily CTO Brian Otis gave his thoughts in a blog post at the time, stressing the learnings the company got from the project. In a recent interview with MobiHealthNews, Novartis Global Head of Digital Development Jacob LaPorte...
By Dave Muoio November 19, 2018
The FDA is seeking public comments for a proposed framework that would allow the majority of apps and software released by pharmas that accompany a drug treatment to avoid lengthy premarket review submissions. According to a notice released last week, such software would be viewed as “promotional labeling,” and therefore only require submission to the FDA’s Office of Prescription Drug Promotion (...
By Jonah Comstock November 16, 2018
Four years after announcing an ambitious — and often ridiculed — project to create a glucose-sensing contact lens along with Novartis subsidiary Alcon, Alphabet's Verily is throwing in the towel, the company announced in a blog post today. It will continue to work on two other medical contact lens projects, aimed at presbyopia and cataract surgery recovery. "Our clinical work on the glucose-...
By Jonah Comstock November 15, 2018
Belgian biopharma company UCB has tapped customer engagement company Verint Systems to create an app for patients with Parkinson's disease. The app is called PD Coach and includes an AI assistant named April which can communicate with users either by text or speech. At launch, the app will support journaling and symptoms tracking. April is programmed with a wealth of Parkinson's-specific...
By Jonah Comstock November 7, 2018
By and large, Q3 2018 was a slow and steady quarter for pharma moves in digital health, at least in terms of publicly disclosed operations. At events during the quarter, the likes of Johnson & Johnson, AstraZeneca, Novartis and Sanofi discussed digital therapeutics and expressed a healthy mixture of skepticism and enthusiasm for the space. “These technologies have a tremendous opportunity to...

The digital health landscape, from the Digital Therapeutics Alliance's new report.

By Jonah Comstock October 31, 2018
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:   "...
By Jonah Comstock October 23, 2018
Update: This article has been updated to clarify potentially misleading claims about Novo Nordisk being first to market. Novo Nordisk has struck a deal with Flex Digital Health, part of the IoT logistics company Flex, formerly known as Flextronics. Novo Nordisk will use Flex's BrightInsight platform, which focuses on managing connectivity and compliance for regulated digital health devices, as it...
FDA Pre-Cert panel at Connected Health Conference

(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)

By Jonah Comstock October 19, 2018
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.  "...
By Dave Muoio October 17, 2018
OptimizeRx, a software company focused on pharma-provider digital health messaging, has completed a $9 million deal to acquire medication adherence and care coordination messaging company CareSpeak Communications, OptimizeRx told MobiHealthNews. With this deal, OptimizeRx will be able to expand its EHR-embedded messaging platform so that phrama and providers can communicate directly with patients...