India
pti-Deepika S
New Delhi, Jan 15: Dr Reddy’s Laboratories on Friday said it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine for COVID-19.
The phase 3 study of Sputnik V will be conducted on 1,500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in the country, the Hyderabad-based firm said in a regulatory filing.
Earlier this week, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment.
In its report, the DSMB had concluded that no safety concerns were identified and the study met the primary endpoints of safety.
“This is an important milestone in the progress of this pivotal…