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The U.S. FDA has posted an immediately-in-effect policy document regarding clinical laboratory development of diagnostics for the pathogen responsible for COVID-19 disease. The agency said the policy allows a lab to use any diagnostic before the FDA has completed an exhaustive review of the test.
BioWorld looks at translational medicine, including: Finding the next pandemic threat early on; Microglial fresh start helps heal brain trauma; Finding the silent majority; Anatomy study reveals schizophrenia subtypes; Increasing immune activity improves autoimmunity; How cancer cells hibernate…; …And who makes their bed; Blocking trash trashes MSI-hi tumors; New splicing factor implicated in muscular dystrophy.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agex, Altimmune, Generex, Graybug, Merck, Sonoma, Therapix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alphatec Holdings, BGI, Cetius Tech, Clearsense, Complete Genomics, Cytosorbents, Eos Imaging, Illumina, Labvantage Solutions, Leica Microsystems, Master Dynamic, MGI, Nevro, New World Development, Perkinelmer, Stimwave Technologies, Surgicalone, Transenterix, Verato.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaxis, Anokion, Brainstorm, Clene, Gilead, Incysus, Inflazome, Iteos, Mapkure, Neurimmune, Polypid.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anpac Bio-Medical Science, Emit, Medidata, Pillo Health, Pulmodyne, Ra Medical Systems, Nordion, Pelican Engineering, Redhawk, Roche, Sedana, Westinghouse.
Keeping you up to date on recent developments in diagnostics, including: Chest CT bests assays in diagnosing Covid-19; Sweat sensor keeps tabs on stress; Oligodendrocyte-neural connections not just about myelin; Sharper look yields new potential kinase target in ovarian cancer.
Rated the No. 1 most prepared country in the world to tackle an epidemic, the U.S. could see its preparedness put to the test as it responds to the growing COVID-19 outbreak. While the administration is pointing to that rating from a recent global survey to calm fears about the risk in the U.S., the coronavirus emergency is spotlighting cracks in the nation’s preparedness.
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