Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Biotechnologies, Cardiacsense, Joimax, Scientia Vascula, Surmodics, Vela Diagnostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anavex, Catalyst, GSK, Jaguar, Neurorx, Organicell, Redhill, Relief, Tonix, Y-mabs.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Astrazeneca, Aveo, CSL, Daiichi, Galmed, Glaxosmithkline, Immatics, Iovance, Kyowa Kirin, Mirati, Oric, Seattle Genetics, Sab, Som, Veracyte.
Developers of tests for the SARS-CoV-2 virus have gained a tremendous amount of experience in a very small amount of time, and of all the media for sampling, saliva offers the easiest route for test administration. The U.S. FDA’s Tim Stenzel said on the Aug. 5 testing town hall, however, that the FDA and developers have discovered that this is an extremely difficult medium to work with.
With strong results in hand from the phase I stage of its phase I/II study testing a would-be COVID-19 subunit vaccine, Novavax Inc.’s president of R&D, Gregory Glenn, said “it’s possible we could go down in the dose” as work proceeds and get similar efficacy.