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Submit complete safety data: CDSCO panel tells Novartis on Remibrutinib
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug maker Novartis to submit complete safety data of the ongoing study of Bruton's tyrosine kinase inhibitor Remibrutinib till date for further review by the committee to allow an extension of the current study.Bruton's tyrosine kinase inhibitor...
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug maker Novartis to submit complete safety data of the ongoing study of Bruton's tyrosine kinase inhibitor Remibrutinib till date for further review by the committee to allow an extension of the current study.
Bruton's tyrosine kinase inhibitor Remibrutinib demonstrates promising efficacy and safety in chronic spontaneous urticaria.
This came after the firm presented the proposal for a grant of Phase III clinical trial permission with Protocol No. CLOU064A2303B; Version: 00 dated 30-May-2022.
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.