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).
The latest global regulatory news, changes and updates affecting biopharma, including: Association for Accessible Medicines, Department of Justice, EMA, FDA, Federal Trade Commission, International Coalition of Medicines Regulatory Authorities, SEC, White House, World Health Organization.
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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Becton Dickinson, Biotechnology Innovation Organization, Cme America, Ortho-Clinical Diagnostics.
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
TORONTO – The Government of Canada is fast tracking importation of two U.S. manufactured test kits for COVID-19, issuing an interim order for sale of the Cobas SARS-CoV-2 diagnostic test kit developed by Pleasanton, Calif.-based Roche Molecular Systems Inc. and Waltham, Mass.-based Thermo Fisher Scientific Inc.’s Taqpath COVID-19 Combo Kit.