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Remsima SC (infliximab biosimilar SC) / CelltrionCelltrion Healthcare Receives Positive CHMP Opinion for an Additional Five Indications for Remsima SC Including for Use in Inflammatory Bowel Disease and Ankylosing Spondylitis (Businesswire) - Jun 28, 2020 - "Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the existing marketing authorisation for the subcutaneous (SC) formulation of Remsima (CT-P13) in an additional five indications: for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis....'Remsima SC could offer patients an alternative administration method that provides adequate exposure during maintenance treatment with infliximab and takes significantly less time than the current intravenous formulation, thereby reducing the time patients need to be in medical settings with infusion administrations,' said Professor Walter Reinisch....Celltrion has completed its application process for patent protection for the Remsima SC formulation and dosage, until 2037 and 2038 respectively in approximately 100 countries throughout the US, Europe and Asia."
MORF-057 / Morphic TherapMorphic Therapeutic Presents Positive Preclinical Data Supporting Development of MORF-057 in Inflammatory Bowel Disease at Digestive Disease Week 2020 (GlobeNewswire) - Jun 29, 2020 - "The data presented at DDW demonstrate that MORF-057 successfully targets the integrin α4β7 with high potency and selectivity. These studies recapitulate results from previous in vitro and in vivo models of increasing complexity and bolster the emerging profile of MORF-057 by demonstrating saturation of α4β7 in non-human primate receptor occupancy studies...IND filing on track for mid-year and phase 1 clinical trial expected third-quarter 2020..."
spesolimab (BI 655130) / Boehringer IngelheimBI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis (clinicaltrials.gov) - Jul 1, 2020 - P2; N=79; Recruiting; Sponsor: Boehringer Ingelheim; N=535 --> 79
EUPHORIA: Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (clinicaltrials.gov) - Jul 2, 2020 - P; N=504; Not yet recruiting; Sponsor: iThera Medical GmbH
