 "Covid-19 pandemic: Bharat Biotech’s Covaxin set for clinical trials in US")
Hyderabad-based Bharat Biotech will conduct clinical trials of Covaxin in the US after it hit a roadblock to secure emergency use authorisation for its Covid-19 vaccine from the US drug regulator.
The company’s US partner, Ocugen, said on Thursday it would follow the biologics licence application (BLA) route to seek full licensure of Covaxin in the US.
Bharat Biotech said Ocugen had received a recommendation from the FDA to pursue BLA path for Covaxin, which is full approval. “All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, the data
The company’s US partner, Ocugen, said on Thursday it would follow the biologics licence application (BLA) route to seek full licensure of Covaxin in the US.
Bharat Biotech said Ocugen had received a recommendation from the FDA to pursue BLA path for Covaxin, which is full approval. “All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, the data
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