CAJICA, Colombia - The Cuban government announced the successful development of a COVID-19 vaccine, but little is known about it beyond announcements that it has already started phase I trials.
The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said.
PERTH, Australia – Australian public health laboratories are collaborating to sequence the virus genomes of all positive COVID-19 tests in Australia to track the virus using genomics across the country. The Communicable Disease Genomics Network (CDGN) and Illumina Inc. will track COVID-19 by using next-generation genomic sequencing technology.
A Sept. 16 Senate hearing revisited the Trump administration’s response to the COVID-19 pandemic, and the CDC took the opportunity to post a vaccine distribution plan. CDC director Robert Redfield advised the committee, however, that sufficient quantities of vaccine to cover everyone in the U.S. might not be available until the third quarter of 2021, adding that now is the time to stand up a distribution network for a vaccine that will require cold-chain storage.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axim Biotechnologies, Baxter International, BioIQ, Biomérieux, Care G.B., Corza Health, General Biologicals, Invotek, Labcorp, Mediwound, Medtronic, Myomo, Nanox, Opgen, Pacgen, Pathogenx, PhysIQ, Premier, Solutions in Critical Care, Takeda, Tempus, Todos, Varian, Vibrent Health, Vitalconnect, Vivera.
Siemens Healthineers AG snagged a key role in the mystery playing out across the world's pandemic stage – what do antibody test results mean in terms of immunity to SARS-CoV-2 and how do different tests assessing different proteins compare? The U.S. CDC and the Joint Research Centre (JRC) of the European Commission tapped the Erlanger, Germany-based company to take the lead in developing a process to standardize antibody assays.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerapedics, Controlrad, Eurobio Scientific, Fibralign, GE Healthcare, Genmark Diagnostics.
