News | December 30, 2021
Biological E gets nod to study Corbevax as a booster dose
The Subject Expert Committee has recommended grant of permission to conduct Phase 3 trials under certain conditions
The Subject Expert Committee has recommended grant of permission to conduct Phase 3 trials under certain conditions
Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. Neutralizing antibodies in children on an average 1.7 times higher than in adults
The company has developed the API in house at its R&D center in Hyderabad
It plans to deliver over 300 million doses to the Indian government
The authorization provides an additional treatment option against the Covid-19 virus in the form of a pill that can be taken orally
Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
Sputnik Light as a booster significantly increases virus-neutralizing activity against Omicron based on sera 2-3 months after revaccination and is a universal booster to other vaccines inducing stronger antibody and T-cell response
The company will collaborate with U.S.-based colleagues to help life sciences companies improve commercial effectiveness
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
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