Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Agios, Astrazeneca, Bluebird, BMS, Cytodyn, Essa, GW, Intellia, Takeda, Zealand.
Disaster Management Group (DMG), of Indiantown, Fla., has launched a 15-minute screening tool for COVID-19 that can be administered at drive-thru testing sites. The DMGtest, which is being offered under an FDA waiver, first rolled out in Florida and will soon be available in other parts of the U.S.
Citing the rapidly changing situation related to COVID-19, Watford, U.K.-based Smith+Nephew plc said it is withdrawing its 2020 outlook. It highlighted COVID-19’s spread beyond China, as well as the slow pace of recovery for elective procedures in that country.
TORONTO – The Government of Canada is fast tracking importation of two U.S. manufactured test kits for COVID-19, issuing an interim order for sale of the Cobas SARS-CoV-2 diagnostic test kit developed by Pleasanton, Calif.-based Roche Molecular Systems Inc. and Waltham, Mass.-based Thermo Fisher Scientific Inc.’s Taqpath COVID-19 Combo Kit.
The newest angle in the partnership between Johnson & Johnson and the U.S. federal government, part of the company’s $1 billion commitment to COVID-19 R&D, is designed to drive its lead candidate into the clinic by year-end and to increase its vaccine manufacturing worldwide.