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.
As hospitals faced a deluge of patients early in the COVID-19 pandemic, many implemented remote solutions to manage individuals at home to keep from being overwhelmed – all at a speed unthinkable in more normal times. That experience promises to accelerate and transform telemedicine long after the threat of COVID-19 recedes, according to a report by Vizient Inc.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA taking adcomm nominations; HHS, DoD ink deal with Cue Health; NTAP town hall set for Dec. 15-16.
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.
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