Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Life Whisperer, Phosphorus, Sagico, Spinal Elements.
CAJICA, Colombia – Aided by federal funds from the Brazilian government, the University of Sao Paulo is moving forward with developing a precision SARS-CoV-2 vaccine that is about to start preclinical trials.
The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerus, Ancora Heart, Corelink, Endra Life Sciences, Illuminoss Medical, Kardium, Livsmed, Qure.ai, Seegene.
LONDON – Scientists investigating the impact of SARS-CoV-19 on protein expression in human cells have shown that infected cells develop virus-laden membrane protrusions, or filopodia, which may explain the rapidity of viral spread through the body.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Boston Scientific, Envoy Medical, Orthofix.
Keeping you up to date on recent developments in cardiology, including: COVID-19 an independent risk factor for acute ischemic stroke; New heart valve holds hope for open heart surgery; Company unveils results on therapy to treat cardiovalvular diseases.
The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push is now on several relatively novel points of emphasis, including high-throughput testing, a technology that may prove critical to corralling the SARS-CoV-2 virus when flu season arrives later this year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Babson Diagnostics, Circadia Health, Ekso Bionics, Medtronic, Nyxoah, Viraxclear.
