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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA