Specialty Pharma Journal Specialty, Precision & Technology
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, …
Tag Archives: ulcerative colitis
November, 2018
October, 2018
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10 October
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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8 October
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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5 October
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 …
July, 2018
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19 July
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 …
June, 2018
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7 June
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 …
May, 2018
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31 May
Gilead and Galapagos Announce Positive Results with Filgotinib in Psoriatic Arthritis and Progression into Phase 3 Ulcerative Colitis Study
FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) announced that the randomized, placebo-controlled Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint of improvement in …
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31 May
Pfizer’s Xeljanz Receives FDA Approval for Treatment of Moderately to Severely Active Ulcerative Colitis
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately …
December, 2017
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15 December
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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14 December
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 …