The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO says wound care spending dropped between 2016 and 2018; FDA updates COVID testing data; May 2019 Q-sub guidance appears in final form.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Bioserenity, Nirmidas Biotech, Spark Biomedical, Trinity Biotech.
COVID-19 vaccines have taken most of the limelight lately, but therapies are making progress, too, with San Diego-based Atyr Pharma Inc. and Cerecor Inc., of Rockville, Md., separately offering favorable phase II news.
Relief spread across the world in December when the first two mRNA COVID-19 vaccines received emergency use approvals, although that deep sigh was short-lived as a highly-transmissible SARS-COV-2 mutation began to make its rounds, highlighting the need for continued research to strengthen the arsenal.
The exceptional and speedy response in bringing safe and effective vaccines and therapeutics to combat COVID-19 has kept investors engaged and supportive. As a result, not only have companies involved in this research and development benefited, but so has the sector as a whole. Those biopharma companies have enjoyed significant jumps in their share values, with the BioWorld Drug Developers index closing up 4.6% in December and up 29% for 2020.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Arcturus, Ascentage, Atriva, Chipscreen, Cure, Genentech, Marius, Marker, Moderna, Ovoca, Precigen, Roche, Zosano.
The U.S. FDA’s device center may still be grappling with the COVID-19 pandemic throughout the remainder of fiscal year 2021, but that does not mean other considerations have disappeared. The FDA’s Erin Keith said the agency will keep working on a major overhaul of the quality systems regulation (QSR) but will also work toward expanding industry’s use of advanced manufacturing technologies, such as additive manufacturing.
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