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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axsome, Diurnal, Pharmacyte, Revive.
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