The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.
“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.
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.
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