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Ulcerative Colitis

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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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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Pfizer’s Xeljanz Demonstrates Positive Results in its Late-Stage Ulcerative Colitis Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated …

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Brazil Approves Hospira’s Remsima, a Biosimilar Version of Remicade

The National Health Surveillance Agency in Brazil, ANVISA, has approved the first biosimilars monoclonal antibody for use in the country. Leading biosimilars drugmaker Hospira, Inc. announced that its partner Celltrion has received approval for its Remsima (infliximab) for use in Brazil. The drug is the first biological medication approved by …

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Biogen’s Biosimilar Version of Remicade Accepted for Review by EMA

Biogen recently announced that European health regulators have accepted its biosimilar version of Remicade for review. The company said that the Marketing Authorization Application (MAA) for SB2, its biosimilar infliximab candidate using Remicade as a reference product, has been validated for review by the European Medicines Agency (EMA). The application …

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Samsung Submits Application to the EMA for its Remicade Biosimilar Candidate, SB2

South Korea’s Samsung Bioepis Co., Ltd. recently announced that it has submitted a marketing authorization application (MAA) for SB2, its Remicade (infliximab) biosimilar candidate to European health regulators. The company said that it has submitted the MAA to the European Medicines Agency (EMA). The MAA for SB2 is the second …

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