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Ulcerative Colitis

Arena Reports Positive Long-Term Data from the Open-Label Extension of the Phase 2 Trial Evaluating Etrasimod in Ulcerative Colitis

SAN DIEGO, Jan. 7, 2019 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive data from the open-label extension (OLE) of the Phase 2 OASIS trial of its investigational drug candidate etrasimod, a next-generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator in development for the treatment of moderate to severely active ulcerative …

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Janssen Submits Application for FDA Approval of Stelara for Treatment of Moderately to Severely Active Ulcerative Colitis

HORSHAM, Pa., Dec. 20, 2018  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis. STELARA …

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Amgen Submits BLA to the FDA for ABP 710, a Biosimilar Candidate to Infliximab

THOUSAND OAKS, Calif., Dec. 17, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE® (infliximab). “At Amgen, we have spent nearly four decades developing, manufacturing and producing transformative medicines. We’re leveraging our deep expertise and …

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Generex Biotechnology Expands Medical Device & Wound Care Portfolio with Acquisition of Regentys Corporation

MIRAMAR, Fla.–(BUSINESS WIRE)–Generex Biotechnology Corporation (OTCMKTS:GNBT) is pleased to announce that the company has signed a Binding Letter of Intent to acquire 51% of Regentys Corporation, a regenerative medicine company focused on developing treatments for patients with gastrointestinal (GI) disorders. The company’s first product, Regentys Extra-Cellular Matrix Hydrogel, is a first-in-class, …

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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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New Phase 3 Data Show Single Dose of Stelara Induces Clinical Remission and Response in Adults with Moderate to Severe Ulcerative Colitis

BEERSE, Belgium–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data showing treatment with a single intravenous (IV) dose of STELARA® (ustekinumab) induces clinical remission and response in adults with moderate to severe ulcerative colitis (UC) who previously experienced an inadequate response or intolerance to conventional or biologic therapies. …

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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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Takeda Announces New Positive Phase 3 Data of Subcutaneous Vedolizumab in Ulcerative Colitis

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE:4502] (“Takeda”) today announced top-line results from the VISIBLE 1 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab for maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) who achieved clinical response* at week 6 …

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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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