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 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.
As the demand increases for ventilators to treat Americans with severe symptoms of COVID-19, another shortage is being exacerbated – a shortage of the drugs needed to treat patients on ventilators.
Olympus Medical Systems Group, of Center Valley, Pa., a division of Olympus Corp., is preparing the U.S. launch of the Itind device for the treatment of benign prostatic hyperplasia (BPH), following FDA de novo authorization earlier this year. The nonsurgical, minimally invasive treatment is made by Medi-Tate Ltd., of Or-Akiva, Israel.
With the COVID-19 pandemic overwhelming hospitals and treatment centers, San Jose, Calif.-based Outset Medical Inc. scored a big win with U.S. FDA clearance of its Tablo hemodialysis system for home dialysis use. The company will begin rolling the system out for home patients in the coming months, balancing that program with demand for onsite devices to support an upswell in COVID-driven dialysis treatments.
Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
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.
Cerus Corp., of Concord, Calif., is teaming up with several collaborators in its home state, with an eye toward optimizing convalescent plasma therapy for COVID-19 patients.
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.
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