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onvatilimab (CI-8993) / CurisCuris announces FDA clearance of IND application for CI-8993, the first-in-class monoclonal anti-VISTA antibody (PRNewswire) - Jun 10, 2020 - "Curis, Inc…announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CI-8993, the first-in-class monoclonal anti-VISTA antibody. Curis plans to initiate a Phase 1a/1b study of CI-8993 in the second half of 2020…The multi-center, open-label Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors will evaluate approximately 50 patients, with the goal of identifying a recommended dose and schedule."dihydroergotamine mesylate intranasal (INP104) / Impel NeuroPharmaImpel NeuroPharma announces primary objectives met in pivotal phase 3 registration study of INP104 for the treatment of acute migraine (PRNewswire) - Jun 10, 2020 - P3; N=360; STOP-301 (NCT03557333); Sponsor: Impel NeuroPharma Inc. "Results showed the STOP-301 study met its primary objectives, with no new safety signals or concerning trends in nasal safety findings observed for INP104....No drug-related serious adverse events (SAEs) were observed over the entire 52-week study....Exploratory efficacy data in the FSS (n=354) observed that 66.3% of patients achieved pain relief and 38% of patients achieved pain freedom....Impel NeuroPharma plans to submit a New Drug Application to the FDA in the second half of 2020."abrocitinib (PF-04965842) / PfizerPfizer announces positive top-line results from JADE TEEN trial of abrocitinib in adolescents with moderate-to-severe atopic dermatitis (Pfizer Press Release) - Jun 10, 2020 - P3; N=225; JADE TEEN (NCT03796676); Sponsor: Pfizer; "Pfizer Inc....announced today positive top-line results from the Phase 3 JADE TEEN study of abrocitinib...in patients 12 toKalydeco (ivacaftor) / VertexVertex announces European Commission approval for Kalydeco (ivacaftor) for children and adolescents with cystic fibrosis between the ages of 6 months and 18 years with the R117H mutation in the CFTR gene (Vertex Press Release) - Jun 10, 2020 - "Vertex Pharmaceuticals...announced that the European Commission has granted approval of the label extension for KALYDECO® (ivacaftor) to include the treatment of children and adolescents with cystic fibrosis (CF), ages 6 months and older and weighing at least 5 kg, who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene....Now approved, KALYDECO® (ivacaftor) will be immediately available to additional eligible patients in Germany and shortly in countries..."
