Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerami, Argenx, Blade, CTI, Moderna, RDIF, Taysha.
The U.S. National Institutes of Health (NIH) said it has developed a novel method of sample preparation for tests for the SARS-CoV-2 virus, which could trim time and costs for diagnostic testing for COVID-19. This approach bypasses the RNA extraction step, thus eliminating the need for some supplies, and NIH said this technique is available for co-development or licensing with the private sector, giving the smart testing company access to a patent-protected technology with an existing demand already built in.
PARIS – A consortium led by French clinical and scientific experts has just published results in the Journal of Experimental Medicine of a study showing the contribution of a new simplified diagnostic test in better identifying the level of contagiousness of subjects infected with SARS-CoV-2.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Alpha Healthcare, Anatomage, Baylis, Bioaesthetics, Biosyent, Boston Scientific, Elekta, Healthcare Services Group, Helius Medical Technologies, Humacyte, ID Genomics, Iotron Medical Meadowlands Diagnostics, Osteoid, Photocure, Provista Diagnostics.
Brii Biosciences Ltd. made strides toward getting its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, to market with positive interim phase III data that show high-risk outpatients may benefit from the combination therapy up to 10 days following symptom onset.
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.
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