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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alibaba Cloud, Avellino Labs USA, Aytu Bioscience, Bio-Rad Laboratories, Boqi International Medical, Chongqing Guanzan Technology, Co-Diagnostics, Cosara Diagnostics, Endra Life Sciences, Medtronic, Milken Institute, Novocure, Paragon Genomics, Vitalhub, Vizient, Zorion.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, CHF Solutions, Qiagen.
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.
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.
