Glaxosmithkline plc and Vir Biotechnology Inc.’s sotrovimab has become the latest COVID-19 antibody to be pulled from the market in the U.S., after the FDA revoked its emergency use authorization (EUA) because of the rise of the omicron BA.2 subvariant.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, BMS, CNS, Starton, Tiziana.
Investigators at Boston Children's Hospital have demonstrated that SARS-CoV-2 infection of blood monocytes and lung macrophages in the lung could kill the cells via pyroptosis, increasing inflammation and leading to severe COVID-19.
Even as many in the U.S. are looking for the end of the COVID-19 public health emergency, Health and Human Services (HHS) Secretary Xavier Becerra reinforced expectations April 5 that he will continue the emergency declaration into the summer, if not beyond. When asked during a Senate Finance Committee budget hearing if he saw the emergency ending this summer, Becerra declined to give a date, but reiterated his commitment to give stakeholders at least 60 days’ notice.
Preclinical data on two newly designed mRNA molecules from Sunshine Biopharma Inc., of Montreal, showed they are effective at killing cancer cells grown in culture. Tests were performed on a variety of cancer cells, including multidrug-resistant breast cancer cells, ovarian adenocarcinoma cells and pancreatic cancer cells, while toxicology studies using normal human cells showed that the mRNA molecules had little or no cytotoxic effects.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Acer, Alnylam, Ascletis, Blade, Cansino, Curis, Immunitybio, Immunocore, Janssen, Junshi, JW, Kite, Nobelpharma, Precigen, Regeneron, Roche, Sanofi.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Celeristx, Boehringer, Ginkgo, Iktos, Microba, Teijin, Tonix.
After COVID-19 reached a pandemic peak in January due to the omicron variant, infections in the U.S. are now hitting the lowest levels since March of 2020. During the past week, there were 195,963 confirmed SARS-CoV-2 infections in the country, according to Johns Hopkins University data. That is 5.5% fewer infections than the same week two years ago and 56% fewer than last year. Deaths are also down to 5,602 for the week, although there were lower points in the spring and summer months of 2020 and 2021.
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