Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month.
President Donald Trump has issued an executive order enabling the Defense Production Act, which gives the U.S. Department of Health and Human Services broader leeway to conscript industrial production to deal with the COVID-19 outbreak.
LONDON – As the epicenter of the COVID-19 epidemic shifted to Europe and the number of deaths in Italy exceeded the toll in China, the EU stepped up efforts to mount a coordinated response, with a big boost for collaborative R&D funding and a call for clinical research to be pooled in multicenter, multi-arm randomized controlled trials.
As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus.
DUBLIN – The Genentech arm of Basel, Switzerland-based Roche Holding AG plans to move its interleukin-6 (IL-6) inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Astrazeneca, Applied DNA, Cansino, Cytodyn, Dicerna, Gilead, Hansoh, Janssen, Merck, Novartis, Oramed, Takis and Virpax