Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Carmell, Carsgen, Cytodyn, Diffusion, Eiger, Green Valley, Halozyme, Janssen, Mateon, Neurocrine, Polyneuron, Takeda.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Avadel, Axsome, CTI Biopharma, Harpoon, Hua, Italfarmaco, Myovant, Regeneron, Sanofi, Valo.
Siemens Healthineers AG expects to have a total antibody test available in late May 2020 to identify individuals exposed to the SARS-CoV-2 virus that causes COVID-19. The rapid diagnostic test detects IgM as well as IgG and other antibodies in the blood.
Pittsburgh-based Alung Technologies Inc. has received emergency use authorization from the U.S. FDA for its Hemolung Respiratory Assist System (RAS) to treat lung failure caused by COVID-19. The technology could help to ease demand for ventilators, which have been in short supply in coronavirus hot spots, and provide an alternative for patients who can’t tolerate mechanical ventilation.
Vayyar Imaging Ltd., which focuses on 4D radar imaging, reported that the Israeli government is using its sensor technology to fight the spread of COVID-19. “Vayyar uses 3D imaging to map what is happening in any environment but incorporates a fourth dimension – detecting and analyzing changes over time – to provide the most comprehensive monitoring solution,” Ofer Familier, general manager of Vayyar, told BioWorld.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Biocode, Assure Holdings, Cylera, Doctor On Demand, Evanston Technology Partners, Micron Solutions, Nexstim, Readcube, Royal Philips, Tauriga Sciences, Thermo Fisher Scientific, Vizient.
PERTH, Australia – Australian stem cell company Mesoblast Ltd.’s shares were up nearly 39% on the news that its allogeneic cell therapy showed an 83% survival rate in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) treated at New York’s Mount Sinai Hospital.