Tag: EUA

FDA denies emergency use nod for Covaxin in US – ET HealthWorld

New Delhi: The US Food and Drug administration has denied approval for emergency use of Bharat Biotech’s Covaxin, and has asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker has said. FDA recommended that Ocugen “pursue a Biologics Licence Application (BLA) submission instead of an EUA application” and “requested additional […]

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FDA earlier told that no new EUA will be approved for covid vaccines: Bharat Biotech – ET HealthWorld

Hyderabad-based Bharat Biotech today said that the USFDA had earlier communicated that no new Emergency Use Authorisation (EUA) will be approved for covid vaccines, a day after its US partner Ocugen hit a major bump after FDA rejected EUA for Covaxin. The Pennsylvania-based eye disease company had to change its application from an Emergency Use […]

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Roche receives emergency use approval in India for its investigational Antibody Cocktail used in the treatment of Covid-19 – ET HealthWorld

Mumbai, 5 May 2021: Roche India today announced that the Central Drugs Standards Control Organisation (CDSCO) has provided an Emergency Use Authorisation (EUA) for Roche’s antibody cocktail (Casirivimab and Imdevimab) in India. This approval was based on the data that have been filed for the EUA in the United States, and the scientific opinion of […]

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Bharat Biotech ramps up Covaxin production capacity to 700 mn doses per annum – ET HealthWorld

To support vaccination campaigns in India and across the globe, Bharat Biotech has ramped up the manufacturing capacity of its Covid-19 vaccine, Covaxin, to 700 million doses per annum, the vaccine maker said on Tuesday. Manufacturing scale-up has been carried out in a stepwise manner across multiple facilities at Hyderabad and Bangalore, the company said […]

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Sputnik V manufacturing in India to begin after EUA nod – ET HealthWorld

Hyderabad: The buzz over Russian Covid-19 vaccine Sputnik getting emergency use authorization (EUA) nod in India is getting stronger. But Indian manufacturers that have tied up with Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF), are yet to begin manufacturing the vaccine’s doses. Pharma industry sources say commercial manufacture of Sputnik V in India […]

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Bharat Biotech applies for emergency use authorization of Covaxin in Philippines

New Delhi: As part of the globalization of India-developed COVID-19 vaccine, India’s Bharat Biotech has applied for “Emergency use authorization” (EUA) in the Philippines. EUA was filed earlier this month in the country and is the first international regulatory filing for Bharat Biotech’s COVAXIN. Once approved by the local regulator, India is expected to donate […]

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Hyderabad: Bharat Biotech seeks nod to start intranasal vaccine trials – ET HealthWorld

HYDERABAD: After receiving emergency use authorisation (EUA) approval for indigenous Covid-19 vaccine Covaxin, Bharat Biotech has now applied to the country’s drug regulator for permission to conduct phase I and II trials of its intranasal vaccine candidate. It has been codenamed BBV154. The candidate, being developed in collaboration with the University of Washington School of […]

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Oxford Covid-19 vaccine may become the first to get Indian regulator’s nod for emergency use – ET HealthWorld

NEW DELHI: With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford Covid-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots here. Once the UK drug […]

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