INTP53 (vedolizumab biosimilar) / Intas - LARVOL DELTA

Intas Pharmaceutical Gets CDSCO Panel Nod To Study Vedolizumab Powder For Concentrate For Solution For Infusion (Medical Dialogues) - "Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase I clinical trial of Vedolizumab Powder for Concentrate for Solution for Infusion 300 mg/vial....After detailed deliberation, the committee recommended the approval to conduct the Phase I clinical trial as per the protocol presented by the firm."

New P1 trial • Immunology

Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Vedolizumab for Ulcerative Colitis (Medical Dialogues) - "Intas Pharmaceuticals has got the go-ahead from the Subject Expert Committe (SEC) functional under the Central Drugs Standard Control Organisation(CDSCO) to conduct a Phase III clinical trial to compare the efficacy, safety, immunogenicity, and pharmacokinetics of the proposed biosimilar of Vedolizumab (INTP53) Intravenous injection and Vedolizumab reference for induction and maintenance therapy in patients with moderate to severely active ulcerative colitis."

Clinical protocol • New P3 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis