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.
COVID-19 continues to dominate biopharma nonprofit collaborations and grants in 2020, with the pandemic accounting for 85% of projected values reported this year, most of which have posted since the start of July.
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.
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