Dr. Reddy’s-RDIF gain DCGI approval to start Phase 2/3 Sputnik V trial
Category: #health  By Saipriya Iyer  Date: 2020-10-20
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Dr. Reddy’s-RDIF gain DCGI approval to start Phase 2/3 Sputnik V trial

Dr. Reddy’s Laboratories, an Indian pharmaceutical company, and RDIF (Russian Direct Investment Fund) have reportedly gained the DCGI (Drug Control General of India) approval. The approval is associated with the commencement of the Phase 2/3 clinical trial of Sputnik V, a COVID-19 vaccine, in India.

Dr. Reddy’s Laboratories’ Managing Director & Co-chairman, G V Prasad, has commented on the recent development by stating that it will enable the company to start the human trial of the highly anticipated vaccine in India. It is targeting to bring a safe and effective vaccine against the deadly COVID-19 disease.

In September 2020, Dr. Reddy’s inked a partnership with RDIF to jointly conduct the Sputnik V trial and distribute the vaccine across the country. As per their agreement, RDIF will supply 100 million vaccine doses to this Indian company upon receiving regulatory approval in India.

Sputnik V, the vaccine developed by the Gamaleya Research Institute of Epidemiology & Microbiology, was registered in August 2020 by the Ministry of Health of the Russian Federation. It is the 1st registered vaccine in the world against the virus, developed by using human adenoviral vectors.

RDIF’s CEO, Kirill Dmitriev, has stated that the company is excited to collaborate with the regulators in India. Apart from the Indian clinical trial data, its team will deliver the safety & immunogenicity study results from the Phase 3 trial in Russia, which will further support the clinical development of the vaccine in the country.

Following the DCGI approval, the pharmaceutical company has highlighted that the Phase 2/3 trial will be a randomized and multicenter controlled study to examine its safety and immunogenicity. Currently, Sputnik V is under the Phase 3 trial in Russia, with the proposed number of 40,000 subjects. Moreover, the Phase 3 trial of this vaccine has recently commenced in the UAE.

After the announcement, Dr. Reddy’s stock has increased by nearly 2.5%, with an intraday high of Rs.5,213.50 ($71.09) per share.

Source credit:

https://www.indiainfoline.com/article/news-sector-pharma-healthcare/dcgi-approves-dr-reddy-s-and-rdif-to-conduct-clinical-trial-for-sputnik-v-vaccine-stock-gains-120101900054_1.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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