Improving metabolic disorders without major changes in diet and exercise is typically seen as impossible, unless bariatric surgery is involved. But that’s precisely what Fractyl Laboratories Inc. aims to do. It plans to start a pivotal trial of its duodenal mucosal resurfacing system, Revita DMR, before year end.
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.
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