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Ulcerative Colitis

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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FDA Extends Action Date for Xeljanz sNDA in Ulcerative Colitis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC). The …

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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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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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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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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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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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