December 3, 2018
The FDA has announced the winners of the opioid addiction innovation challenge the agency launched last May. Out of more than 250 applications from medical device developers, the FDA selected eight winners.
"While these products will not automatically receive marketing authorization from the FDA, the device developers will receive increased interaction with CDRH experts, guidance for clinical...
November 30, 2018
About the Author: Jack is a marketing and community associate at Dreamit, where he focuses on sourcing and evaluating health tech startups and creating opportunities for Dreamit to engage with the startup ecosystem in New York City and beyond. Before joining Dreamit, Jack worked as an associate at Bombas, a mission-driven, high-end apparel startup. He graduated cum laude from Haverford College...
Novartis' recently-opened digital health innovation lab in San Francisco. Photo courtesy Novartis on Twitter.
November 21, 2018
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...
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.
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...
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 (...
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-...
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...
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.
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: