Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clinithink, Fox Biosystems, Harald AI, Heartbeat Health, Immunovia, Katalyst Diagnostics, Macatt Medica, Pixcell, Vygon.
The world’s largest genomics study in patients with life-threatening COVID-19 infections has uncovered 16 new genetic variants associated with severe disease and drawn up a roadmap for research into new therapies and diagnostics. The research involved comparing the complete genome sequences of 7,491 patients admitted to 224 intensive care units in the U.K. against those of 48,400 participants in Genomics England’s 100,000 Genomes project, and of a further 1,630 people who had mild COVID-19. While some of the gene variants found in the Genomicc study affect the function of a protein, others influence the amount of the protein that is expressed. An example is mucin-1, where overexpression led to worse outcomes.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Breg, Calyx, Clinchoice, J2 Medical, Oncimmune, Premier, Tytocare.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Aravax, Bharat Biotech, Biogen, Eisai, Merck, Nymox, Ocugen.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: American Cryostem, Aravive, Atreca, Coherus, Eli Lilly, Equillium, Evofem, Incyte, Mink, Recursion.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Circa Scientific, KSL Diagnostics, SQI Diagnostics.
The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.
PERTH, Australia – The independent data safety monitoring board of the global REMAP-CAP COVID-19 study has uncovered a concerning safety signal in treatment arms that include an angiotensin converting enzyme inhibitor and an angiotensin receptor blocker in patients with severe COVID-19, and it has recommended that recruitment be suspended for those treatment arms.
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