Weekly Top News – IBD – June 29, 2020

BMS-986165 / BMS
BMS-986165: Data from P2 trial (NCT03934216) for moderate-to-severe ulcerative colitis in 2021 (Bristol-Myers Squibb) – Jun 27, 2020 – Investor Series Immunology and Cardiovascular: Data from P2 trial (NCT03599622) for moderate-to-severe Crohn’s disease in 2022 or later



Remsima SC (infliximab biosimilar SC) / Celltrion
Celltrion 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….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.”


Remicade (infliximab) / Mitsubishi Tanabe, J&J
Diversigen, Inc. and Alimentiv Inc. Announce Collaboration Agreement for Ulcerative Colitis Research Study (GlobeNewswire) – Jun 25, 2020 – “Diversigen, Inc….today announced they have signed a collaboration agreement for a research study on patients with Acute Severe Ulcerative Colitis (ASUC)….The study, titled: ‘Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis (PROTOS Study),’ is designed to provide new insights into the molecular determinants of response to infliximab (IFX) in patients with ASUC….The results will be jointly owned by Diversigen and Alimentiv, and the data will be co-published upon completion of the study.”


Entyvio (vedolizumab) / Takeda
BRIEF—FDA nod of for Takeda’s US Entyvio facility (The Pharma Letter) – Jun 24, 2020 – “…Takeda Pharmaceutical says the US Food and Drug Administration has approved the company’s submission for its biologics manufacturing facility located in Brooklyn Park, Minnesota for the production of Entyvio (vedolizumab) drug substance. The facility also has capabilities beyond production of Entyvio drug substance to support the study and development of future biologic products.”


Zeposia (ozanimod) / BMS
Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jun 23, 2020 – P3; N=869; Active, not recruiting; Sponsor: Celgene; Recruiting –> Active, not recruiting

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