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Ocugen to buy Liminal’s vaccine manufacturing facility in Canada
pharmaceutical-business-review
January 28, 2022
US-based Ocugen has signed a letter of intent (LOI) to acquire Liminal Biosciences’ manufacturing site located in Belleville...
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Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years
AmericanPharmaceuticalReview
November 08, 2021
Ocugen, Inc., a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that it has submitted a request to the U.S. Food...
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Ocugen seeks FDA EUA for Covid-19 vaccine use in children
Pharmaceutical-Technology
November 08, 2021
Ocugen has sought Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 vaccine candidate, BBV152, for use in children in the age group of two to 18 years.
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Ocugen seeks approval for Covaxin in Canada
expresspharma
July 19, 2021
The move follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults, it said.
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Ocugen commences rolling submission of COVAXIN to Health Canada
pharmaceutical-technology
July 16, 2021
Ocugen has commenced the rolling submission to Health Canada for its Covid-19 vaccine candidate, COVAXIN, which is being jointly developed with Bharat Biotech International for use in the US and Canada.
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Jubilant HollisterStier partners with Ocugen to make Covaxin for US, Canadian markets
expresspharma
June 17, 2021
Jubilant HollisterStier has manufacturing units in Spokane (US) and Montreal (Canada).
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Ocugen and Jubilant Enter COVID-19 Vaccine Partnership
contractpharma
June 16, 2021
Jubilant HollisterStier to manufacture COVAXIN for the U.S. and Canadian markets.
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Ocugen to seek full approval for Bharat Biotech’s Covaxin in the US
pharmaceutical-technology
June 15, 2021
Ocugen has plans to seek full approval for Bharat Biotech’s Covid-19 vaccine candidate, Covaxin, in the US, after the Food and Drug Administration (FDA) declined to grant an Emergency Use Authorization (EUA).
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Ocugen to apply for full US FDA approval of Covaxin, not for EUA
expresspharma
June 15, 2021
Ocugen said the decision was based on a recommendation from the US FDA, which also requested more information and data for full approval.
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Bharat Biotech gets $15 mn upfront from Ocugen for rights to commercialise Covaxin in Canada
expresspharma
June 09, 2021
Ocugen has agreed to pay another $10 million to Bharat Biotech within a month from the commercial launch of Covaxin in Canada.