Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ArcherDX, Eurobio Scientific, Extremity Medical, Perkinelmer.
DUBLIN – The Genentech arm of Roche Holding AG plans to move its interleukin-6 inhibitor, Actemra, into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genmark Dx.
With the number of COVID-19 cases continuing to rise and with people social distancing and quarantining, at-home diagnostics and telehealth offer the means for doctors and patients to get vital answers and care without meeting face to face. Now, Los Angeles-based Scanwell Health has gained exclusive rights to license and distribute a rapid serology test from Innovita Biological Technology Co. Ltd., of Hebei, China, for at-home testing of SARS-CoV-2, the coronavirus that causes COVID-19.
