The U.S. FDA’s device center has declared it will not review emergency use authorization (EUA) requests for lab-developed tests (LDTs) for the COVID-19 pandemic, but on the agency’s most recent town hall, on Oct. 14, FDA officials were uncertain as to whether labs should file those EUAs, leaving labs in a state of limbo yet again.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Enterprise, Ezra, Spectrum Solutions.
LONDON - The world’s first COVID-19 human challenge trial is due to start in London next year, after the government announced £33.6 million (US$42.5 million) funding for the project. In the initial phase, the aim is to establish the dose of SARS-CoV-2 needed to cause infection and to characterize the immune response to virus. That will lead on to tests of individual COVID-19 vaccines, in which volunteers will be challenged with the effective dose of SARS-CoV-2 one month after inoculation.
CAJICA, Colombia – The Russian vaccine candidate Sputnik V, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology to prevent the SARS-CoV-2 virus that causes COVID-19, is undergoing phase III trials in Venezuela under complete secrecy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosensors International, Centogene, DNA Genotek, Dxterity, Everlywell, Fresenius Medical Care, Ossio, Thermo Fisher Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Abbott, Apollo Medco, Beahm Designs, BD, Beroni Group, Caredx, Eko, Genscript Biotech, Labcorp, Machine Solutions, Medovate, Plexision, Quidel, Vygon.
Nec Corp.’s bioinformatics subsidiary Nec Oncoimmunity AS said it is working with Oslo University Hospital to develop an artificial intelligence (AI) platform that will allow the team to design a T-cell diagnostic to complement the current serological tests for infectious diseases, including COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Genalyte.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altrix Medical, Chembio Diagnostics, Eurofins Biomnis, Jud Care, Luxfer, Myriad Genetics, Neurox, Nexgel, Stratus, Transforming Systems, Ursa Health, Vitalhub.
