A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neuromatrix, Snyders Heart Valve, St. Jude Medical, Thermo Fisher Scientific.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alydia Health, BD, Dreamed Diabetes, Sight Sciences.
With phase III COVID-19 vaccine trials each enrolling 30,000 participants or more in the U.S. and randomizing half of them to a placebo arm, only 150 incidents of the coronavirus infection are needed in a trial to show if the vaccine is at least 50% effective, NIH Director Francis Collins testified at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9.
A phase III trial of AZD-1222, an experimental coronavirus vaccine developed by Astrazeneca plc and Oxford University, has been paused due to an unexplained illness that occurred in the U.K., the company said on Sept. 8.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Apros, Ascendis, Beigene, Biomarin, Canbridge, Moleculin, Nanomab, Peptilogics, Precision, Reneo, Sellas.
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