PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Aveo, Concert, Cytodyn, Diurnal, Faron, Mallinckrodt, Mesoblast, Novoteris, Orchard, Y-mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alligator, Eusa, Horizon, Inflarx, Inmed, Lidds, Novo Nordisk, Oncoceutics, Orchard, Ose, Theranexus.
Erlangen, Germany-based Siemens Healthineers AG has secured U.S. FDA clearance for its Rapidpoint 500e blood gas analyzer. Available in CE mark countries since August 2019, the device is used to monitor respiratory distress in critically ill patients, such as those in acute care due to COVID-19.
PARIS – Europe has turned into the epicenter of the coronavirus pandemic, seeing more than 50% of the cases observed worldwide. In fact, whereas the COVID-19 pandemic has begun declining in China where it originated, there are 400,000 cases of coronavirus worldwide, including more than 200,000 infected by SARS-CoV-2 in the 55 sovereign states in continental Europe, where they are mourning more than 18,000 deaths.
It has been predicted that the COVID-19 pandemic would cause business disruption. Now, it has claimed a casualty with Second Sight Medical Products Inc., of Sylmar, Calif., which has been forced to wind down operations, citing the pandemic and the impact it will have on the company’s ability to secure financing. Second Sight, which makes the Argus II retinal prosthesis system, said that effective March 31, 84 of its 108 employees will be laid off.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Becton Dickinson, Biotechnology Innovation Organization, Cme America, Ortho-Clinical Diagnostics.