Keeping you up to date on recent developments in diagnostics, including: A simple point-of-care COVID-19 test; A deep-learning method to predict AMD risk; AP-1 and antidepressant action; Orasure collection device included in Miradx EUA.
LONDON – CEOs of five leading biopharma companies have hit back against any suggestion COVID-19 vaccines and therapies could be approved in advance of phase III data, saying it is imperative the highest standards of quality, safety and efficacy are upheld everywhere. The most important thing is to reinforce to the public the commitment to safety as the number one priority, said Kenneth Frazier, CEO of Merck & Co. Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeon, Cytodyn, Innovent, Nippon Shinyaku.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allergy, AMRI, Astrazeneca, Biocryst, CNS, Deepvax, Diurnal, Enesi, Gilead, Geovax, Ionis, Pharnext, Redhill, Saliba, Vistagen, Xencor.
The need for self-administered surveillance testing finally has a few candidates, thanks to labs and test developers across the globe, and the U.S. FDA is keen on exploiting the opening. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the agency’s Sept. 2 testing town hall that the agency is interested in a test intended to be self-administered multiple times compared to a test validated under a single test approach, a flexibility that may prove critical in advancing the U.S. approach to testing for the COVID-19 pandemic.
As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx.
It turns out that determining who gets a COVID-19 vaccine first can be nearly as challenging as developing the vaccine itself. The timeline is a big part of the challenge.
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