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.
BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks and address the concerns of a biotech industry in dismay.
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.
