During the most infectious COVID-19 month since the pandemic began, January recorded an increase of 82.3 million confirmed cases worldwide, an amount that is fourfold the average monthly increase over the past year. It comes at a time when the highly transmissible omicron variant continues to circulate, bolstered by a new subvariant, BA.2, which is outcompeting its predecessor. Meanwhile, regulatory agencies are authorizing antivirals, swapping monoclonal antibodies based on their efficacy against omicron, and approving new vaccine options, including Novavax Inc.’s protein-based vaccine Nuvaxovid (NVX-CoV2373).
LONDON – A new SARS-CoV-2 sub-variant is showing signs of outcompeting the omicron variant that was first reported in South Africa in late November 2021, and within a month had taken over from its delta predecessor, accounting for 98.8 % of sequenced cases worldwide, as of Jan.25.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Maxim Biomedical.
Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diadem, Endo Tools Therapeutics, Microport CRM, Neurometrix, Seegene, Vuze Medical.
In a speech on Jan. 13, President Joe Biden revealed plans to purchase an additional 500 million at-home COVID-19 tests, bringing the total number the administration expects to provide for free to American households to 1 billion. In addition, Biden said the administration would distribute free “high quality masks.” On Wednesday, the administration said it would provide 5 million rapid COVID-19 tests and 5 million lab-based PCR tests to schools each month to support screening testing and test-to-stay programs.
LONDON – A population level study tracking every pregnancy in Scotland between the start of the pandemic in March 2020 and the end of October 2021 lays bare the devastating impact of COVID-19 on perinatal mortality.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Caredx, Castle Biosciences, Electrocore, Glaukos, Pictor.
