Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Etiometry, Modulim, Nico.Lab, Roche, University of California.
Nearly a year after the SARS-CoV-2 virus first appeared in Wuhan, China, a ray of hope is shining on the world with high efficacy reported for four vaccines and U.S. emergency use authorizations granted to three more therapeutics.
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adapthealth, Aerocare Holdings, Ams, Bayer, Biotricity, Biovo Technologies, Blackford Analysis, Boston Scientific, Change Healthcare, Decision Diagnostics, Eir Healthcare, Electrocore, Ers Genomics, GE Healthcare, Health Decisions, Healthstream, Illumina, Irhythm Technologies, .lumen, Meso Scale Diagnostics, Nanostring, New England Home Medical Equipment, Nuance, Nvidia, Oncobay Clinical, Pieriandx, Premier Medical Laboratory Services, Serb, Stark International Lux, TCA/Genetworx Labs, The iQ Group Global, Vesper Medical, Vivlion.
Despite concerns to the contrary, none of the mutations currently documented in the SARS-CoV-2 virus appear to increase its transmissibility in humans, according to a new analysis of viral genomes from 46,723 people in 99 countries who contracted COVID-19.
With the world experiencing another wave of the coronavirus pandemic that threatens to overwhelm hospitals and testing capacity, the ability to quickly diagnose COVID-19 based on alternative methodologies has become increasingly important. For patients with respiratory symptoms, review of CT scans emerged as a relatively reliable indicator of infection with SARS-CoV-2 from the first days of its emergence, but the need for more accurate readings remains.
Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and RenalytixAI, has received emergency use authorization from the U.S. FDA for its semi-quantitative SARS-CoV-2 IgG antibody test kit. Known as COVID-Seroklir, the test determines the presence and precise level of IgG antibodies. It has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acarix, Applied DNA, Co-Diagnostics, Corticometrics, Kantaro, Rapidrona.
