The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
CDSCO gives the green signal as HGCO19 was safe, tolerable and immunogenic in the participants of the study
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
Studies include Alpha, Beta, Gamma, Delta, Epsilon and Iota and it maintains antibodies for six months after the second dose
It strengthens Syngene’s portfolio as a fully integrated custom biomanufacturer with added mammalian and microbial capabilities for clinical and commercial supplies
Targeting KIT by frameshifting mRNA transcripts as a therapeutic strategy for aggressive mast cell neoplasm
Advances deployment of mRNA technology across vaccines and therapeutics development
The companies anticipate clinical studies to begin in August, subject to regulatory approvals
Production line at Lonza’s site in Geleen will complement the existing production network and support the manufacture of up to an additional 300 million doses per year
New agreement for three further production lines at Lonza’s site in Visp, Switzerland
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