The U.S. FDA has granted several emergency use authorizations (EUAs) to address the COVID-19 pandemic, a series of actions designed to lower regulatory hurdles. Despite these developments, the agency is keeping a close eye on issues, such as product claims, and both federal and state agencies are in a position to prosecute for hoarding and price gouging.
To better tap into the potential of transcranial magnetic stimulation (TMS), Stanford University researchers developed a high-dose, precision-targeted protocol known as Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT).
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.
New York-based Deerfield Management Co. has secured $840 million for a new venture capital fund to support innovations in biotechnology, medical technologies and digital health. James Flynn, managing partner of Deerfield, said roughly half of the fund will focus on early-stage therapeutic R&D, much of that coming from academic partnerships. The remainder will be used to back companies developing novel advances in med-tech interventions, diagnostics and digital health.
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. announced that the FDA gave it the green light to test its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19). “We’re going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus but doesn’t destroy your lungs at the same time,” Mesoblast CEO Silviu Itescu told BioWorld.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acumen Research Laboratories, Allurion Technologies, Almac Clinical Technologies, Artms Products, Beam Therapeutics, Bio-Rad Laboratories, Biotricity, Cure Pharmaceutical, Getinge, Imaginab, Invitae, Ivwatch, James Fisher, The Janz, Medipines, Mesa Biotech, Mirion, Nano-X, Oklahoma State University, Qure.ai, OGT, Parallax, Rapid Medical, United Global Alliance, Vortran, Xerox.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cochlear, Genetron, Gnomegen, Motus GI, Nitiloop, Orthosensor.