LONDON – AM-Pharma BV raised a further $52 million for the phase III trial of its recombinant alkaline phosphatase product, Recap, in treating sepsis-associated acute kidney injury (AKI), but now faces a delay in starting the study, as the COVID-19 crisis takes up more and more clinical resources.
LONDON – Two papers published online in Nature following accelerated peer review provide fine detail of how the spike protein on the COVID-19 coronavirus binds to the angiotensin converting enzyme 2 (ACE2) through which it infects its human host.
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.