Administering multiple booster doses against COVID-19 is not sustainable in the longer term, international drug regulators said during a meeting of the International Coalition of Medicines Regulatory Authorities, held Jan. 12. Regulators argued that a long-term strategy should involve vaccines capable of tackling several variants at once, not just omicron, and that tweaking existing vaccines and comparing them with first-generation vaccines using clinical studies is the way forward, according to a report from the meeting.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Amgen, AN2, Aptorum, Argenx, Beigene, Betterlife, Clairvoyant, Compass, Idorsia, Jeil, Marker, Novavax, Nuvation, Omeros, Opko, Palleon, Pfizer, Rockwell, Senhwa, Turning Point.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alzinova, MD Anderson, Orchard, Revivicor, Sorrento, Tevogen, Trisalus, United Therapeutics, Yingli.
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.
The COVID-19 pandemic has hit supplies and devices across a broad range of categories over the past two years, and the latest addition to the list is the blood collection tube. The FDA announced that this shortage affects all types of blood collection tubes, thus affecting tubes for all uses, not just those used for testing for the SARS-CoV-2 virus.
Fresh data about vaccines by Valneva SE and the Gamaleya Research Institute show strength against COVID-19’s omicron variant. The new results helped continue a worldwide race to create, approve and distribute vaccines to fight the pandemic.
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. Australia’s Therapeutic Goods Administration granted provisional approval on Jan. 20 to Biocelect Pty Ltd. (on behalf of Novavax Inc.) for its COVID-19 vaccine, Nuvaxovid, as well as two oral antiviral treatments.