“It’s coming. We know it’s coming.” That was Nevan Krogan’s blunt reminder that SARS-CoV-2 is not the first virus to wreak temporary havoc on humanity, nor will it be the last.
LONDON – COVID-19 research is generating a wealth of data every day, but it is coming from many and disparate sources, making it difficult to assess its quality, dovetail datasets together and decide how to apply it.
DUBLIN – The Lancet Infectious Diseases has published the first clinical data on BBIBP-CorV, an inactivated whole virus vaccine directed against SARS-CoV-2. The early stage phase I/II study tested the Chinese-developed vaccine in 540 healthy volunteers, including 96 older participants. All vaccine recipients seroconverted and the adverse event profile was mild.
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, Armata, Eton, Merck, Immunitybio, OS, Regeneron, Zhittya.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Apellis, Astex, Castle Creek, Eiger, GNT, Ionis, J&J, Janssen, Kalvista, Lysogene, Oryzon, Otsuka, Regenrx, Regulus, Sage, Vertex.
Despite an NIH move to pause enrollment in a trial testing Eli Lilly and Co.'s COVID-19 antibody candidate, LY-CoV555, after a participant's unexplained illness, at least three other studies of the candidate remain underway, the company said Oct. 14.
Tracking the pandemic in all its manifestations – from symptoms and spread, to viral genomics and repurposing drugs – has massively increased appreciation of the importance of real world data, with significant implications for the future of drug discovery and clinical development, the use of patient data and health care as a whole.
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