LONDON – The Delta variant of SARS-CoV-2 originally identified in India is causing more serious illness and reducing the effectiveness of vaccines compared to the Alpha (Kent) variant, according to a nationwide study covering Scotland’s whole population of 5.4 million.
Novavax Inc. reported an overall efficacy rate of 90.4% in a phase III trial of its COVID-19 protein subunit vaccine, NVX-CoV2373, which it conducted in the U.S. and Mexico. The vaccine provided 100% protection against moderate and severe disease and 100% protection against variants of SARS-CoV-2 deemed not to be of concern or interest. Gaithersburg, Md.-based Novavax is on track to file for approval during the third quarter. By the end of that period, it aims to ramp up production to a monthly run rate of 100 million doses and it aims to scale that to a monthly run rate of 150 million doses by the end of the fourth quarter.
The FDA issued a June 10 warning letter to Innova Medical Group Inc. in connection with the company’s rapid antigen tests for the SARS-CoV-2 virus, an action that accompanies a class I recall and a safety communication.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Caldwell Industries, CM Life Sciences, Dexcom, Encore, Ensodata, Fresenius Medical Care, Humacyte, Integra Molecular, Predictmedix, Sema4, Shockwave Medical, Sientra, Vivante Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Advanced Human Imaging, Arya III, Autolomous, Avantor, Bio-Techne, C2i, Echonous, Eko, Fittrack, Gynesonics, Inqb8, Intervenn, Nautilus Biotechnology, New England Biolabs, Novogeneait, Paxman Coolers, Peijia, Portal Bioscience, Ritter, Trxade Health, Veranome Biosystems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Alpha Tau Medical, Angiodynamics, Elute, Eyeyon Medical, Glaukos, Mimedx, Roche.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta Group, Medtronic, Opgen, Orasure Technologies.
