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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Canon Medical, Quidel.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ambu, ATTC, Biointellisense, Biomerica, Bio-Techne, Centogene, Clinical Laserthermia Systems, Dover, Em-tec, Llamasoft, MeMD, Myriad Genetics, Oxford Nanopore Technologies, Pacific Biosciences of California, Parallax Health Sciences, Qiagen, Rewalk Robotics, Startx, Tomi Environmental Solutions, Tabula Rasa Healthcare, Windgo.
Undetected cases were a major driver of the early spread of SARS-CoV-2 in Wuhan, China, despite being less infectious on a case-by-case basis, according to a modeling study published in the March 16, 2020, online issue of Science.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ariosa Diagnostics, Illumina, Transmedics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Neural Fiber Optic Systems, Medx Health.
