Drug Approval | June 30, 2022
India’s first mRNA vaccine from Gennova gets DCGI approval
It is a two dose vaccine to be administered intramuscularly at 28 days apart
It is a two dose vaccine to be administered intramuscularly at 28 days apart
105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses
Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine
An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56.
Alliances with CVS Health and Javara further embed clinical research into the community healthcare setting, expanding access to patient populations across the U.S to increase diversity in clinical trials
Both manufacturing facilities are based out of Benguluru, India
Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation
Redbiotec has a right to royalties on Eurocine Vaccines´ net sales of an approved HSV-2 vaccine, should such sales arise.
Acceptance based on results from the phase 3 KEYNOTE-091 trial
TAK-003 is currently undergoing regulatory review for potential licensure in both the European Union
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