PERTH, Australia – In preparation for easing COVID-19 restrictions and opening its international borders, Australia has added a new vaccine and two new oral antiviral therapies to its arsenal to fight the omicron variant of the SARS-CoV-2 virus that is sweeping the globe.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Akeso, Antares, Ascletis, Astrazeneca, Biolinerx, Bionanosim, Canbridge, CASI, Celcuity, Daiichi Sankyo, Dyne, Egetis, Evaxion, Hookipa, Jacobio, Levo, Medivir, Pfizer, Polarity, Recbio, Shanghai Green Valley, Sparx, Sorrento, Vera.
South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Novavax Inc.’s Nuvaxovid, making it the first protein-based COVID-19 vaccine to be approved for commercial use in the country. The regulatory win for Novavax adds to emergency use authorizations (EUA) for the product, also known as NVX-CoV2373, in India, Indonesia and the Philippines, as well as an emergency use listing from the World Health Organization. On Jan. 12, the company said it expects to submit an EUA request to the FDA after one month.
Sema4 Holdings Corp. sent a bold message to the market with a definitive agreement to acquire Genedx Inc. from Opko Health Inc. for $623 million. The deal comes as Sema4 winds down its COVID-19 testing by the end of March. The company has been one of the largest testing organizations in Connecticut since its first contract in May 2020, but has lately come under scrutiny because of an investment by Annie Lamont, the governor’s wife.
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.