Ocugen, a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines, was informed by the U.S. Food and Drug Administration (FDA) that the agency placed its Phase 2/3 immuno-bridging and broadening study for COVAXIN™ (BBV152), OCU-002, on clinical hold.
Ocugen said in a press release Teusday that this was a result of its decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility.
“We will work with the FDA to address any questions”, the company said in its annoucement.