Amyris and ImmunityBio JV for next gen Covid-19 RNA vaccine
Upon completion of successful human trials and regulatory approval, the joint venture's goal is to start delivering the second-generation vaccine in 2022 as soon as is practically possible
Upon completion of successful human trials and regulatory approval, the joint venture's goal is to start delivering the second-generation vaccine in 2022 as soon as is practically possible
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 Subject Expert Committee has recommended grant of permission to conduct Phase 3 trials under certain conditions
All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
Covaxin is formulated uniquely such that the same dosage can be administered to adults and children
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
SAGE recommends additional third dose of the vaccine administered to immunocompromised persons
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
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
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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