The COVID-19 pandemic has sparked some innovation in testing, but not all that innovation has made it to market. Michael Mina, an assistant professor of epidemiology at the Chan School of Public Health at Harvard University, said on an Aug. 7 conference call that the U.S. FDA’s “archaic view” of testing is impeding the use of paper strip tests he said would turn the tide in the effort to contain the pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Guardant Health, Scientia Vascular.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arc Medical Design, Anpac Bio-Medical Science, BBS-Bioactive Bone Substitutes, Bruker, Establishment Labs Holdings, Highmark, Mdxhealth, Norgine Orion Trading, Olympus, Sbl Technologies, Senseonics, Sparta, Todos Medical.
Out of 922 biopharma financings so far in 2020, nearly a quarter of them – 211 – were done by companies working on a COVID-19 therapeutic or vaccine. More strikingly, however, the $27.8 billion raised by those pandemic-focused firms represents about 40% of the $71.8 billion total collected through the end of July. That amount is the highest BioWorld has ever tracked.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biogen, Canbridge, Cytodyn, Eisai, Intellia, Kazia, PTC, Roche, Viiv.
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.