The digital medicine company Physiq Inc. has received a contract from the NIH to develop an artificial intelligence (AI)-based index that can provide an early warning that a patient with COVID-19 is in decline and needs medical treatment. The index, called the COVID-19 Decompensation Index (CDI) Digital Biomarker, will run on Physiq’s existing Accelerateiq computing platform, analyzing physiological data from FDA-cleared wearable devices to create a personalized baseline for patients who have tested positive for COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Axonics, Simplify Medical, Visby Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Medical Technology Association, Biocept, Boston Scientific, Dariohealth, Decision Diagnostics, Exagen, Gunze, Hancock Jaffe, Highmark, Hmc Healthworks, Icad, Mimedx, Misonix, Novartis, Ortho Clinical Diagnostics, Polarityte, Radiation Business Solutions, Radmax, Royal Philips, Siemens Healthineers, Startx, Titan Medical.
DUBLIN – Genentech has succeeded where Sanofi SA and its partner, Regeneron Pharmaceuticals Inc., have failed, in obtaining some sort of a positive signal from a clinical trial of an interleukin-6 (IL-6) inhibitor in COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Ampio, Arca, Astrazeneca, Crinetics, I-Mab, Merck, Otsuka, Harbour and Liminal.
The latest global regulatory news, changes and updates affecting biopharma, including: CDER lays out public speech rules for staff; Health Canada opens quicker path for COVID-19 drugs; EMA OKs COVID-19 use of dexamethasone.
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