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SHANKAR MUSUNURI
Covaxin's clinical trials can resume in US as FDA lifts holdThe FDA's earlier decision, in April, to put on hold the trials was based on the US firm's decision to voluntarily implement a temporary pa...- Bharat Biotech's Covaxin gets nod for human trials in the US"We are pleased to be able to move our clinical program for Covaxin forward, which we hope will bring us closer to offering an alternative ...
- Bharat Biotech's partner seeks Covaxin nod in US for children between 2 and 18 yearsThe US-based firm has applied for the authorisation based on the basis of the results of phase 2 and 3 clinical trials conducted on 526 chi...
- Bharat Biotech's US partner Ocugen files request with FDA for Covaxin trialsThe US firm in a press release said the Phase 3 trial, proposed in the IND, is designed to establish whether the immune response experience...
- Bharat Biotech's partner Ocugen seeks approval for Covaxin in CanadaThe move follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 a...
- Bharat Biotech ties up with Ocugen to commercialise Covaxin in CanadaUnder the agreement, Ocugen will have the US rights to the vaccine candidate and will be responsible for clinical development, regulatory a...
- FDA rejects EUA for Covaxin, 'suggests' Biologics Licence Application route for approval in USOcugen in a statement on Thursday announced that as recommended by theFDA,it will pursue submission of a biologics licence application (BLA...
- Bharat Biotech's partner seeks full approval for Covaxin in USThis follows the recommendation of the USFDA and it means that, subject to regulatory approvals, it will take a longer time for Covaxin to ...
- Ocugen to file for full US approval of COVID-19 shot Covaxin instead of EUAOcugen said the decision was based on a recommendation from the U.S. Food and Drug Administration (FDA), which also requested more informat...
- Ocugen pays $15 mn upfront to Bharat Biotech for Covaxin rights in CanadaThe Indian biotech company and Ocugen Inc have entered into a definitive agreement to co-develop, supply, and commercialise Covaxin for the...
- Bharat Biotech needs to give phase-3 efficacy data for WHO nodInclusion in the EUL is also important for easy international travel of Indian citizens who have been administered Covaxin.
- Ocugen seeks to sell 100 million doses of Bharat Biotech's Covaxin in US in 2021The Pennsylvania-based biopharmaceutical firm is partnering with India's Bharat Biotech, a developer of the vaccine, to commercialize the s...
- Bharat Biotech, Ocugen sign pact for supply of Covaxin to US marketThe companies have entered into a definitive agreement for Covaxin, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, ...
- Bharat Biotech, Ocugen to co-develop Covaxin for US marketAs per the letter of intent (LOI), "Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be ...
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