Pharmaceutical company Dr Reddy's Laboratories Ltd (BSE:500124) (NSE:DRREDDY) (NYSE:RDY) has initiated the process for Emergency Use Authorization (EUA) of Russian COVID-19 vaccine Sputnik V in India, the company said on Friday.
As part of the review process, Dr Reddy's will present the Drugs Controller General of India (DCGI) with the safety profile of the phase 2 study and interim data from the phase 3 study, which is expected to be completed by 21 February 2021.
Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF) in September 2020 to conduct clinical trials of Sputnik V and for its distribution rights in India.
The vaccine reportedly demonstrated an efficacy rate of 91.6% in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia who received both the first and second doses of the vaccine.
"The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India," said G V Prasad, co-chairman and managing director of Dr Reddy's.
BeOne Medicines' sonrotoclax receives FDA Breakthrough Therapy Designation for MCL
Biophytis and Asian consortium to fund first Phase 3 trial in sarcopenia
Aptamer Group secures GBP112,000 contract with top 10 global pharmaceutical company
IP Group positions for future royalties following Pfizer's USD7.3bn acquisition of Metsera
Jubilant HollisterStier's Washington facility launches new high-speed isolator based Line
Assembly Biosciences reports positive interim Phase 1b data for herpes treatment candidate ABI-5366
Dubai Culture and Zayed University Invite Global Creatives to Participate in ISEA2026
VolitionRx proposes underwritten public offering of common stock and common stock warrants
Celltrion's biosimilar EYDENZELT (aflibercept-boav) approved by US FDA
WuXi Biologics recognised with MSCI AAA ESG rating for third consecutive year
Tempus selected by ARPA-H to provide CRO and testing services for ADAPT cancer programme