LONDON – Two new U.K. studies point to long-term persistence of COVID-19 antibodies after both natural infection and vaccination, conferring protection against subsequent infection for at least three months.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aruvant, Asana, Biocryst, Innovent, Prothena, RDIF.
Visby Medical Inc. secured $12.3 million in funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a next generation device to detect influenza and COVID-19 in a single point-of-care rapid PCR test and, subsequently, as an over-the-counter test for consumer use. The contract may be extended up to a total of $48.7 million over a period of 38 months based on meeting certain milestones in the base period, according to Visby Founder and CEO Adam de la Zerda.
PERTH, Australia –Digital diagnostics company Ellume Ltd. announced a US$231.8 million agreement with the U.S. Department of Defense (DoD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic U.S. production of its COVID-19 home tests. The agreement includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the U.S.
As solid efficacy data are reported for at least four more front-runner vaccines, and while biopharma companies join arms with combination antibodies, SARS-CoV-2 variants continue to spread and countries are racing to vaccinate. None of the research is slowing, and governments are determined to make sure another COVID-19 pandemic never again takes the world by surprise. Global deaths are up to 2.2 million, with 102.9 million confirmed cases, according to the World Health Organization. At least 865 therapeutics and vaccines to fight the virus have entered development in the last year.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC reports on cases, sequencing; NICE says savings seen with Cytosorb; IP at issue as WTO pushes for global pandemic effort; Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
LONDON –The Russian COVID-19 vaccine Sputnik V now has validation from the Western science establishment, after The Lancet published full interim results of the phase III trial on Feb 2. The peer-reviewed paper confirms the 91%-plus efficacy that the vaccine’s developer, Gamaleya National Center of Epidemiology and Microbiology, claimed in its own announcement of the results in December.
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