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.
The latest global regulatory news, changes and updates affecting biopharma, including: Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, BMS, Cerecor, Chinook, Durect, Kintor, Mustang, Neurmedix, Paxmedica, Russian Direct Investment Fund, Sesen, SQZ, VBI Vaccines.
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.
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