PERTH, Australia – The British Standards Institute (BSI) granted Sydney-based Oncosil Medical Ltd. European CE marking approval for its brachytherapy device to treat locally advanced pancreatic cancer in combination with chemotherapy, clearing the way for marketing in both the EU and the U.K. BSI also granted the Oncosil device breakthrough therapy designation.
Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.
The jury is still out on how much hydroxychloroquine and chloroquine actually help in the treatment or prevention of COVID-19, but desperate times have led desperate health care providers to use the antimalarial drugs to treat patients in desperate need of coronavirus cures.
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.