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Ocugen has submitted key information and data to date including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies as a Master File for FDA review and input prior to a planned EUA submission.
Emergency use authorisations were obtained in 13 countries with more set to follow. Bharat Biotech expects to receive regulatory approvals from the World Health Organization (WHO) for Covaxin in the July-September quarter. It had already submitted an application to the WHO seeking Emergency Use Listing for the vaccine, the company said on Tuesday. Regulatory approvals for the vaccine are in process in more than 60 countries, the firm said. Emergency use authorisations were obtained in 13 countries with more set to follow. Meanwhile, Bharat Biotech’s partner in the U.S. Ocugen Inc. said it...
BioLife Solutions Announces First Quarter 2021 Financial Results Achieves record quarterly revenue of $16.8 million, a 39% increase over the prior year and 14% increase over the prior quarter Full year revenue guidance raised to $106 to $115 million reflecting confidence in outlook Additions to leadership team and board position company for continued robust growth serving the cell and gene therapy and biopharma markets Conference call begins at 4:30 p.m. Eastern time today News provided by Share this article , Inc. (Nasdaq: BLFS) ("BioLife" or the "Company"), a leading developer and supplier...
Author Bio Keith began writing for the Fool in 2012 and focuses primarily on healthcare investing topics. His background includes serving in management and consulting for the healthcare technology, health insurance, medical device, and pharmacy benefits management industries. Follow @keithspeights What happened Shares of Ocugen (NASDAQ:OCGN) were tanking by 12.7% as of 11:16 a.m. EDT on Friday after falling as much as 20.6% earlier in the day. The big decline came after the company provided its first-quarter update before the market opened today. So what Ocugen didn'...
and Variant Neutralization Results — In April 2021, Ocugen announced that its co-development partner, Bharat Biotech International Limited ("Bharat Biotech"), shared positive results from the second interim analysis of its Phase 3 clinical trial of COVAXIN showing 78% overall efficacy against COVID-19 disease, 100% efficacy against severe COVID-19 disease (including hospitalization), and 70% efficacy against asymptomatic COVID-19 infection, indicating the potential to significantly reduce virus transmission. COVAXIN has additionally demonstrated a remarkable safety profile with several mil...