Tag: Ocugen

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 rejects Ocugen’s emergency use authorization for Bharat Biotech’s Covaxin in the US, seeks nod from Health Canada

Biopharmaceutical company, Ocugen, has announced that recommendation from the U.S. Food and Drug Administration (FDA), the company will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN. The Company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN. COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in […]

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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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FDA rejects EUA for Covaxin, ‘suggests’ Biologics Licence Application route for approval in US

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. Ocugen in a statement on Thursday announced that as recommended by theFDA,it […]

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Ocugen to file for full US approval of Covid-19 shot Covaxin instead of EUA – ET HealthWorld

Ocugen Inc said on Thursday it would no longer pursue an emergency use authorization for its Covid-19 vaccine candidate, Covaxin, and would instead aim to file for a full U.S. approval of the shot. Ocugen said the decision was based on a recommendation from the U.S. Food and Drug Administration (FDA), which also requested more […]

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Ocugen pays USD 15 mn upfront to Bharat Biotech for Covaxin rights in Canada – ET HealthWorld

Ocugen Inc, the US partner for Bharat Biotech‘s Covid-19 vaccine, has announced the payment of USD 15 million upfront to the Indian drug maker for extending the vaccine rights to Canada. Ocugen in a regulatory filing said it has agreed to pay another USD 10 million to Bharat Biotech within a month from the commercial […]

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