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Crohn’s Disease

Microbiotica Enters into Microbiome Collaboration with Genentech

CAMBRIDGE, England–(BUSINESS WIRE)–Microbiotica, a leading player in microbiome-based therapeutics spun out of the Wellcome Sanger Institute, today announced that it has entered into a multi-year strategic collaboration with Genentech, a member of the Roche Group, to discover, develop and commercialise biomarkers, targets and medicines for inflammatory bowel disease (IBD). Under …

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Data Shows Treatment with Janssen’s Stelara Reduced Rates of Hospitalization and Surgery in Moderate-to-Severe Crohn’s Disease

WASHINGTON DC–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson announced today a new analysis looking at two-year data from the IM-UNITI long-term extension (LTE) STELARA® (ustekinumab) programme, which demonstrated that two dosing regimens of ustekinumab (90mg administrated every 12 [q12w] and 8 [q8w] weeks), can decrease the risk of Crohn’s …

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FDA Approves Pfizer’s Ixifi, a Biosimilar to Remicade

Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved IXIFI as …

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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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