China’s NMPA has given conditional approval to Pfizer Inc.’s COVID-19 oral pill Paxlovid (nirmatrelvir/ritonavir). The drug was approved for the treatment of adults with mild to moderate COVID-19 and a high risk of progression to severe disease. This includes the elderly, and people with chronic kidney issues, diabetes, cardiovascular, and chronic lung disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Biontech, Cytryx, Eli Lilly, Innovent, Journey Medical, Metacrine, Noema, Novavax, Pfizer, Pharmacyte, Roche, Spectrum, Veru, Y-mabs.
The overwhelming focus of research into the cellular immune response to SARS-CoV-2 has been investigating the reaction of vaccinated people, in an effort to establish correlates of protection required to fight off infection. But with a majority in many African and Asian countries still unvaccinated, it also is important to understand the natural cellular immune response, and to track the emergence of SARS-CoV-2 variants with the potential to escape immunity in these populations.
Delivering important but likely unwelcome news to Americans increasingly trying put the COVID-19 pandemic behind them, new research published Feb. 11 by the CDC suggested that "protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection against COVID-19-associated [emergency department or urgent care (ED/UC)] encounters and COVID-19 hospitalizations."
Redhill Biopharma Inc. continues pushing ahead with efforts to add to the limited arsenal of therapies for treating hospitalized severe COVID-19 infections, with the latest data, based on prespecified analyses from a phase II/III study showing its SK2 inhibitor, opaganib, significantly reduced mortality when given on top of standard-of-care (SOC) Veklury (remdesivir, Gilead Sciences Inc.) and corticosteroids. The Tel Aviv, Israel-based company said potential emergency use and marketing applications are planned in the first half of this year.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biontech, Cassava, Edigene, Johnson, Legend, Metacrine, Moderna, Pfizer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Center for Pain & Stress Research, Esaote North America.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cstone, Dermata, Elpiscience, Eureka, Gamida, Glenmark, Polypid, Qurient, Sanotize, Synthetic Biologics.
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