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Crohn’s Disease

FDA Approves Sandoz’s Biosimilar Hyrimoz (adalimumab-adaz) for all Indications of Reference Medicine

Holzkirchen, Germany, October 31, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, HyrimozTM (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years …

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Enterome and Takeda Enter Licensing, Co-Development and Co-Promotion Agreement for Crohn’s Disease Treatment

ENTEROME SA, a clinical-stage biotech company developing innovative therapies to treat microbiome-associated diseases with a focus on auto-immune disease and cancer, has entered into a global licensing, co-development and co-promotion agreement with Takeda Pharmaceutical Company Limited (“Takeda”). The agreement covers Enterome’s lead investigational drug candidate EB8018 in patients with Crohn’s disease, …

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New Real-World Data Analyses Support the Long-Term Use of Entyvio in Bio-Naïve Patients for the Treatment of Moderate to Severe Ulcerative Colitis or Crohn’s Disease

Deerfield, IL, October 8, 2018 – Takeda Pharmaceuticals U.S.A., Inc., (“Takeda”) today announced the presentation of new long-term efficacy real-world data analyses for Entyvio® (vedolizumab) at ACG 2018 in Philadelphia, PA. Studies of note include a retrospective multicentre cohort study of biologic-naïve adults with ulcerative colitis (UC) and Crohn’s disease (CD), two …

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Allergan Launches Personalized Study Approach for Clinical Research Programs in Inflammatory Bowel Disease

DUBLIN, Oct. 5, 2018 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced the initiation of two global clinical research programs for brazikumab, an investigational drug being studied for inflammatory bowel disease (IBD). INTREPID (Crohn’s disease) and EXPEDITION (ulcerative colitis), will evaluate the safety and efficacy of brazikumab and will investigate the role of biomarkers …

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Arena’s Olorinab Demonstrates Positive Phase 2a Results in Patients with Abdominal Pain Associated with Crohn’s Disease

SAN DIEGO, Sept. 24, 2018 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq :ARNA ) today announced positive topline results from its Phase 2a trial of olorinab, an investigational, peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 (CB2) in development for the treatment of gastrointestinal pain. Phase 2a Trial …

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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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