More than 21 months since the SARS-CoV-2 virus was first identified in Wuhan, China, the questions just keep coming, and the longer they go unanswered, the more divisive the opinions become. Controversies over the efficacy of current vaccines, over whether boosters are necessary for the general population, over the safety of COVID-19 vaccines for young children, over how to distribute the shrinking supply of highly effective monoclonal antibodies, and over how the virus originated in the first place – all of these looming questions have created a firestorm of uncertainty that will not stop burning.
When the SARS-CoV-2 virus first emerged in the U.S., the knee-jerk reaction by biopharma researchers was to make the best vaccines and therapeutics possible and to do so quickly. Since then, the number of those that have entered development has reached 1,001, more than for any other viral infection aside from HIV.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ANP Technologies, Breathesuite, Koya Medical, Medtronic, Nanowear, Nonagen, Seaspine, Selux Diagnostics.
Horseshoe or Rhinopolus bats in Laos carry coronavirus species with a near-identical receptor binding domain to SARS-CoV-2, according to a paper posted on the preprint server Research Square by investigators from the Pasteur Institutes of Paris and Laos.
Trimers of nanobodies, a simpler form of antibody made by some animal species, were effective at preventing and treating COVID-19 in preclinical studies, researchers reported in the Sept. 22, 2021, issue of Nature Communications. The findings, along with others, could form the basis of an inhaled biologics treatment for COVID-19 and, ultimately, other respiratory diseases.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocartis, BK Medical, Digital Therapeutics Alliance, Draper, Evoendo, Gamma Biosciences, GE Healthcare, Neuroone, Orasure Technologies, Roche Diagnostics Canada, Second Genome, Squid Healthcare, Theromics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Ivwatch, Kleiner, Welldoc.
Trimers of nanobodies, a simpler form of antibody made by some animal species, were effective at preventing and treating COVID-19 in preclinical studies, researchers reported in the Sept. 22, 2021, issue of Nature Communications.
The COVID-19 pandemic is still swirling about, and rapid antigen tests are still playing a vital role in pushing back against the COVID-19 pandemic, and Australia’s TGA has responded with a guidance on when software used with rapid antigen tests qualifies as a regulated device. The TGA has classified such software as a class 3 device when used with a rapid antigen self-test, thus requiring a separate regulatory application before it can be eligible for entry in the Australian Register of Therapeutic Goods (ARTG).
LONDON – Researchers in the U.K. have applied the heft of national population-level databases to devise a new algorithm that predicts those people who are most at risk of hospitalization and death from COVID-19, despite having received two doses of vaccine.
