2DG has been given emergency approval by the Drug Controller General of India (DCGI) for COVID-19 patients in the country
The company said it had received a clearance from the Drugs Controller General of India V.G. Somani last week to conduct the clinical trial on mild to moderate covid-19 patients
It is considering seeking an emergency licence from the DCGI if it has successful phase 2 data
Biological E is currently conducting phase 1 and 2 clinical trial of the Baylor College-developed vaccine, and plans to soon seek approval from the Drugs Controller General of India for phase 3 trials
The SEC is tasked with vetting applications for covid-19 diagnostics, vaccines and drugs, and recommend to the Drugs Controller General of India V.G. Somani whether to approve the application or not.Typically, the DCGI follows the recommendation made by the panel
COVAXIN is India’s ‘first’ indigenous COVID-19 antibody, created by Hyderabad-based Bharat Biotech in a joint effort with ICMR and NIV.Indian specialists have given the green light to test Bharat Biotech’s COVID-19 antibody in Phase I and Phase II clinical preliminaries.India’s first potential COVID-19 antibody has been given endorsement for Phase I and Phase II clinical preliminaries.Named COVAXIN™, the immunization was created by Bharat Biotech and has been allowed endorsement from the Drugs Controller General of India (DCGI).Human clinical preliminaries are booked to begin across India in July 2020Bharat Biotech made COVAXIN in a joint effort with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).As indicated by the organization, the SARS-CoV-2 strain was confined in NIV, Pune and moved to Bharat Biotech.The indigenous, inactivated immunization was created and made in Bharat Biotech’s office situated in Hyderabad, India.The DCGI conceded consent to start Phase I and II human clinical preliminaries after the organization submitted results created from pre-clinical investigations, illustrating “promising” and “broad” security and safe reactions.Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, stated: “We are pleased to declare COVAXIN, India’s first indigenous immunization against COVID-19.The coordinated effort with ICMR and NIV was instrumental in the improvement of this immunization.The proactive help and direction from CDSCO has empowered endorsements to this task.
Today the company Equillium reported that clinical trials of their drug itoizamub “significantly reduced mortality” in patients with COVID-19. Equillium is a clinical-stage biotechnology company whose focus is largely COVID-19-related – like many companies of this sort at the moment. They reported today that a Biocon, India clinical trial with itolizumab “significantly reduced mortality in patients hospitalized with COVID-19.” As … Continue reading