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Crohn’s Disease

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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Pfizer Announces the US Availability of Biosimilar Inflectra

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the company will begin shipment of INFLECTRA® (infliximab-dyyb) for injection, a biosimilar of REMICADE®1 (infliximab) to wholesalers in the United States (U.S.) in late November 2016. INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be …

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Celgene Announces Results from Early-Stage Study of Investigational Crohn’s Disease Pill

VIENNA–(BUSINESS WIRE)–Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of investigational oral GED-0301 (mongersen) 160 mg on both endoscopic response and clinical remission in patients with active Crohn’s disease will be presented in …

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Allergan Enters $1.5 Billion Licensing Agreement with AstraZeneca for Inflammatory Disease Candidate

DUBLIN, Oct. 3, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that it has entered into a licensing agreement with MedImmune, AstraZeneca’s global biologics research and development arm, for the global rights to MEDI2070. MEDI2070 is an anti-IL-23 monoclonal antibody currently in Phase IIb clinical development for the treatment …

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Janssen’s Stelara Receives FDA Approval for Treatment of Adults with Crohn’s Disease

PR Newswire, Horsham, Pa., September 26, 2016 — Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with …

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FDA Approves Amgen’s Humira Biosimilar for Treatment of Seven Inflammatory Diseases

THOUSAND OAKS, Calif., Sept. 23, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment …

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Pfizer’s Remicade Biosimilar Candidate Succeeds in Late-Stage Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced the confirmatory study (REFLECTIONS B537-02) evaluating the efficacy, safety, and immunogenicity of PF-06438179 (infliximab-Pfizer) compared to Remicade® (infliximab) met its primary endpoint. The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology …

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RedHill Biopharma’s Crohn’s Disease Drug Shows Potential Efficacy in Trial

TEL-AVIV, Israel, June 22, 2016 RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, today announced the publication of an article demonstrating the potential …

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Samsung Bioepis’ Infliximab Biosimilar Recommended for Approval in the European Union

INCHEON, Korea – April 1, 2016 – Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Flixabi® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of …

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