Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Impedimed, Phase Scientific, Vapotherm, Visby Medical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Microtransponder.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioventus, Johns Hopkins University, Merck, Millar, Ontada, Schwarzer Cardiotek, Todos Medical, Trice Medical, University of Washington School of Medicine.
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.
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.
LONDON – The latest data from the large-scale randomized U.K. COVID-19 infection survey confirm vaccines are less effective against the Delta variant of SARS-CoV-2 that is now dominant across the U.S., Europe and elsewhere in the world.
PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.
When SARS-CoV-2 first emerged in 2020, with respiratory symptoms as the most obvious feature of infection, the most obvious comparison was to influenza. COVID-19, of course, was never just another flu.
