Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
The collaboration aims to deliver greater insights to the oncology fraternity, predict patient therapy responses and enable therapy selection resulting in optimal treatment outcomes.
It answers the most basic questions from a patient’s perspective
FDI increased 98% year on year in 2020 and pharma exports grew by 18% in the last financial year
Filing marks first protein-based vaccine submitted to MHRA for authorization
The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months
The company is continuing with the evaluation of canakinumab in lung cancer, and is applying findings to the overall lung cancer development plan
It’s the company’s fourth manufacturing site worldwide. Others are located in the US, UK and China
This strategic collaboration will enable continued innovation in cancer care
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
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