Page 10 - Master File News Today

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.

URL copied Covaxin has reached 30 cities in the past 30 days Covaxin, Indias indigenous Covid-19 vaccine, has reached 30 cities in the past 30 days, said the vaccine manufacturer Bharat Biotech in a statement on Tuesday. Among 30 cities that have received the Covaxin doses include Delhi, Kolkata, Mumbai, Chennai, Bengaluru, Kochi and Amritsar. Covaxin is one of the three vaccines that the DGCI has cleared for emergency use in India. The two others are Covishield and Sputnik V. While C...

Bharat Biotechs US partner Ocugen submits Master File to FDA on Covaxin Ocugen has submitted key information and data to date as a Master File for FDA review and input prior to a planned EUA submission. Share Via Email   |  A+A A- By PTI HYDERABAD: Ocugen, Bharat Biotechs American partner for COVID-19 vaccine Covaxin, has submitted a "Master File" to the US Food and Drug Administration prior to seeking an emergency use authorisation in that country. "The company is currently evaluati...

Bharat Biotech expects WHO nod for Covaxin in Sept quarter BusinessToday.In © India Today Group Bharat Biotech expects WHO nod for Covaxin in Sept quarter Hyderabad-based Bharat Biotech has confirmed that it has submitted application for emegency use listing (EUL) of its coronavirus vaccine Covaxin before the World Health Organisation. The Indian vaccine manufacturer expects the global health agency to grant the same within July to September period this year. A guidance docu...

COVID-19 vaccine: Bharat Biotechs US partner Ocugen submits Master File on Covaxin to FDA 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 PTI | May 25, 2021 | Updated 14:47 IST Ocugen, Bharat Biotechs American partner for COVID-19 vaccine Covaxin, has submitted a "Master File" to the US Food and Drug Administration p...

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 coun...

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 Shar...

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...

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 vi...