The US-based biotechnology company Novavax has tied up with the Serum Institute of India (SII) to manufacture its Covid-19 vaccine, namely Covovax.
In a setback to Bharat Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation.
Niclosamide has been extensively used in the past for treating tapeworm infection in adults as well as children. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels, the Council for Scientific and Industrial Research (CSIR) said.
Dr. Anthony Fauci on Thursday said the US is eager to involve Indian investigators in global clinical trials to evaluate the safety and efficacy of COVID-19 therapeutics.
Zydus said that its biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild COVID-19.
Globally available Covid 19 vaccines can now be launched in India without the requirement of post approval clinical trials and testing every batch of the vaccine.
Zydus said it is the only Indian company to have developed a neutralizing monoclonal antibody based cocktail for the treatment of COVID-19.
A new Covid-19 vaccine developed by China's Sinopharm has recently been approved for clinical trials.
The expert panel of India's drug regulator, DCGI, has permitted Bharat Biotech to give the third dose of Covaxin to a few volunteers in its clinical trials of the COVID-19 vaccine.
India's indigenously developed vaccine against coronavirus COVAXIN has demonstrated an interim vaccine efficacy of 81 per cent in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with ICMR, informed vaccine maker Bharat Biotech.
India's indigenously developed vaccine against coronavirus COVAXIN has demonstrated an interim vaccine efficacy of 81 per cent in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with ICMR, informed vaccine maker Bharat Biotech.
China has approved 16 domestically made Covid-19 vaccines for clinical trials, six of which have entered phase 3, according to the latest data from the National Medical Products Administration.
The Drugs Controller General of India (DCGI) has given licensing permission to Hyderabad-based Bharat Biotech to manufacture 'Covaxin' for sale and distribution. The DCGI approval document said the firm can vaccinate children above the age of 12 years during the clinical trial mode.
Drug firm Zydus Cadila on Sunday said it has received DCGI approval to initiate Phase III clinical trials of its COVID-19 vaccine ZyCoV-D.
The Phase-II study of the vaccine, ZyCoV-D, had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase-I and II dose escalation, multi-centric, randomised and double-blind placebo controlled study.
The All India Institute Of Medical Sciences (AIIMS) has invited applications for volunteers, who want to take part in the COVAXIN Phase-3 trial, which was indigenously developed by Bharat Biotech.
Covaxin, being developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology, is now undergoing phase-3 trials.
Over 100 experts from friendly neighbouring nations have so far been trained to strengthen capacities in their countries for facilitating phase-3 clinical trials of Indian COVID-19 vaccine, a senior official of the department of biotechnology said on Wednesday.
Drug firm Zydus Cadila on Monday said it has received permission from Drugs Controller General of India (DCGI) to initiate phase-1 clinical trial of its novel molecule ZYIL1, indicated for use as an inhibitor for inflammation condition 'NLRP3'.
In a regulatory filing, Zydus Cadila said it has received approval from the DCGI to start the phase 3 clinical trials in COVID-19 patients with its biological therapy Pegylated Interferon alpha-2b or PegiHep.
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