Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Celyad, Deciphera, Fosun, IMV, Inflazome, Janssen, Vanda, Verrica.
If there’s a readily visible upside to the COVID-19 pandemic, it may be that telehealth is not only much more accessible, it’s also supremely topical among policymakers. However, privacy concerns are still a significant source of drag in some respects, a consideration that extends to digital medicine as well in the context of contact tracing used to corral the SARS-CoV-2 virus.
Electrocore Inc. has snagged an emergency use authorization (EUA) from the U.S. FDA for use of its Gammacore Sapphire CV noninvasive vagus nerve stimulation (nVNS) to acutely treat asthma exacerbations in known or suspected COVID-19 patients. The hand-held therapy can be used at home and in a health care setting.
TORONTO – Edmonton’s University of Alberta is lending its neuromotor research smarts to a wearable, machine learning driven sensors platform developed by Menlo Park, Calif., and Calgary, Alberta-based Protxx Inc. for better managing the future care of patients suffering from neurodegenerative conditions such as multiple sclerosis (MS).
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent.