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.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biohaven, Direct, Enlivex, Harmony, Moderna, Orca, Redhill, Scynexis, Sorrento, Taysha Gene, Tevogen, Y-mabs.
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