DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.

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).

PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.

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.

Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans.