Brii Biosciences Ltd. made strides toward getting its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, to market with positive interim phase III data that show high-risk outpatients may benefit from the combination therapy up to 10 days following symptom onset.
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.
As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances.
As talk increases of third doses of COVID-19 vaccine, a game-changing option is delivering them intranasally instead of intramuscularly. “It’s all about nasal carriage. It’s a better way to not carry the virus and not make others sick,” Bluewillow Biologics Inc. CEO Chad Costley told BioWorld. “The most important thing is that it’s safe.”
Biopharma company deals with nonprofit entities, as well as grants, are not keeping the same pace as last year, but the proportion of money flowing into COVID-19 efforts continues to account for the majority of those recorded overall.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axsome, Beigene, BMS, GSK, Jupiter, Kalvista, Pfizer, RDIF, Ultragenyx, Valneva, Vir, Xeris, Zydus.
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