Govt panel rejects emergency-use approval for Dr Reddyâs Russian-origin potential Covid drug
The company had requested for waiver of clinical trials in India as a condition to market the monoclonal, antibody-based drug, Olokizumab.
Himani Chandna 30 January, 2021 8:57 pm IST Text Size:
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New Delhi: The Modi governmentâs expert panel has rejected the proposal of Dr Reddyâs Laboratories to grant emergency use authorisation to a Russian rheumatoid arthritis drug, which was repurposed for Covid-19.
The drug, Olokizumab, is manufactured by Russian drug maker, R-Pharm, to treat rheumatoid arthritis drug, which the company is now trying to repurpose for Covid-19.Â
Dr Reddy’s plans to roll out Covid vaccine Sputnik V in India in March
January 29, 2021
A shipment of Sputnik V arriving at Ezeiza International Airport, Buenos Aires, Argentina - Reuters×
Hopes to obtain Emergency Use Authorisation; pricing not yet decided
Pharma major Dr Reddy’s Laboratories Ltd is planning to launch Russian Covid vaccine Sputnik V in India in March after obtaining Emergency Use Authorisation (EUA).
This was disclosed by Deepak Sapra, Chief Executive Office, API & Pharmaceutical Services, Dr Reddy’s, at a virtual press conference organised to announce third quarter results on Friday.
The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, has collaborated with Dr Reddy’s to conduct clinical trials and distribute the vaccine in India.
Dr Reddy’s, GRA terminate Avigan study on hospitalised Covid cases in Kuwait
January 27, 2021
× Dr Reddy’s Laboratories Ltd and Global Response Aid FZCO (GRA) on Wednesday announced the termination of an Avigan Trial Study conducted in Kuwait focussed on moderate to severe Covid patients in a hospital setting.
The hospitalised patient study was one of the studies in the overall clinical programme for Avigan, spanning the spectrum of asymptomatic to severe cases of Covid in both outpatient and in-patient settings. Avigan is a trademark of Fujifilm Toyama Chemical Co Ltd.
The Phase-III study, being conducted in an outpatient setting on patients with mild to moderate symptoms in North America by Dr Reddy’s, in partnership with Appili Therapuetics and Global Response Aid, shall continue.
Business EconomyPosted at: Jan 27 2021 4:12PM
Dr Reddy’s, GRA announces termination of Avigan Pivotal study for hospitalized moderate to severe Covid patients in Kuwait
Hyderabad, Jan 27 (UNI) Dr Reddy’s Laboratories Ltd and Global Response Aid FZCO (GRA) on Wednesday announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting.
While study for out-patient mild to moderate cases continues in North America, the Hyderabad-based Pharmaceutical giant said in a statement here.
The hospitalized patient study, conducted in Kuwait, on moderate to severe patients was one of the studies in the overall clinical program for Avigan, spanning the spectrum of Asymptomatic to severe cases of COVID in both outpatient and in-patient settings.