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Crohn’s Disease

One Year Maintenance and Switching Data in Patients with Crohn’s Disease Support the Use of Inflectra in IBD

NEW YORK–(BUSINESS WIRE)–New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period.1The full 54-week results of the randomized controlled trial comparing INFLECTRA and REMICADE in biologic-naïve patients …

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Celgene Discontinues GED-0301 Inflammatory Bowel Disease Program

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) today announced that the GED-0301 (mongersen) phase III REVOLVE trial (CD-002) in Crohn’s disease (CD) and the extension trial (SUSTAIN, CD-004) will discontinue. Celgene has decided to stop the trials following an October recommendation of the Data Monitoring Committee, which assessed overall benefit/risk during …

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Takeda and SGC to Use Patient Tissue-Based Assays for Clinical Target Validation in IBD

OSAKA, Japan & SAN DIEGO & STOCKHOLM–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502), Karolinska Institutet (“KI”) and The Structural Genomics Consortium (“SGC”) today announced a combined pre-competitive and proprietary collaboration to discover and validate new potential intervention points for the treatment of Inflammatory Bowel Disease (IBD). The agreement establishes …

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Provention Bio Enters Licensing Agreement with Janssen for Two Mid-Stage GI Immunology Candidates

LEBANON, N.J., Sept. 21, 2017 /PRNewswire/ — Provention Bio, Inc., a clinical stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced today that it has entered into agreements with Janssen Pharmaceutica NV and Janssen Sciences Ireland UC [Janssen] to in-license …

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Janssen Enters Deal for Protagonist Therapeutics’ Inflammatory Bowel Disease Candidate

Horsham, Pa., May 30, 2017 ― Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today it has entered into a worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. (Protagonist) to develop, manufacture and commercialize PTG-200, a first-in-class, oral interleukin-23 receptor (IL-23R) antagonist …

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AbbVie Presents Positive Mid-Stage Results for its Investigational JAK1-Selective Inhibitor in Crohn’s Disease

NORTH CHICAGO, Ill., May 9, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced promising results from CELEST, a Phase 2, randomized, double-blind, placebo-controlled study evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in adult patients with moderately to severely active Crohn’s disease. These data are being …

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Samsung Bioepis’ Biosimilar Version of Remicade Receives FDA Approval

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, RENFLEXIS™ is indicated for reducing signs and symptoms in patients with adult and …

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Finch Therapeutics and Takeda Enter New Microbiome GI Collaboration

Osaka, Japan and Somerville, MA, April 5 2017 – Finch Therapeutics, a privately held microbiome engineering company, and Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502), today announced a global collaboration agreement to jointly develop FIN-524. FIN-524 is a live biotherapeutic product in pre-clinical research. It is composed of cultured bacterial …

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Research Uncovers Bacteria Linking Crohn’s Disease to Arthritis

Patients with Crohn’s disease, a type of inflammatory bowel disease (IBD) that causes abdominal pain and diarrhea, can also experience joint pain. In Crohn’s disease, which affects about 800,000 Americans, the immune system can attack not only the bowels, but the musculoskeletal system as well, leading to spondyloarthritis, a painful …

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AbbVie’s Risankizumab Receives Orphan Drug Designation for Treatment of Pediatric Patients with Crohn’s Disease

NORTH CHICAGO, Ill., Nov. 30, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of Crohn’s disease in pediatric patients. Risankizumab is being evaluated in …

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