Ulcerative Colitis

Bristol Myers Squibb Announces Positive Topline Results from Phase 3 True North Trial Evaluating Zeposia in Moderate to Severe Ulcerative Colitis

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE:BMY) today announced results from True North, a pivotal Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis. True North met both primary endpoints, demonstrating highly statistically significant (p-value < 0.0001) results for induction of …

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Gilead and Galapagos Announce Positive Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis

FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase 2b/3 trial evaluating the efficacy and safety of the investigational, oral, once-daily, selective JAK1 inhibitor filgotinib in 1,348 biologic-naïve or …

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Gilead Sciences and Second Genome Announce Strategic Collaboration in Biomarker and Inflammatory Bowel Disease Drug Discovery

FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Second Genome, a leader in microbiome science, today announced that the companies have entered into a four-year strategic collaboration to identify biomarkers associated with clinical response in up to five of Gilead’s pipeline compounds in inflammation, …

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Innovation Pharmaceuticals Phase 1 Trial of Brilacidin for Ulcerative Colitis Meets Primary Endpoints

WAKEFIELD, Mass., Feb. 13, 2020 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to announce that preliminary top-line data from its Phase 1 trial (NCT03234465) studying the use of delayed-release tablets of Brilacidin showed the trial met its primary endpoints. In the study, …

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FDA Approves Amgen’s Avsola (infliximab-axxq), for the Same Indications as Remicade

THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn’s Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in …

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FDA Approves Pfizer’s Biosimilar Abrilada (adalimumab-afzb) for Multiple Inflammatory Conditions

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.2 For full details …

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FDA Approves Janssen’s Stelara for Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

HORSHAM, Pa., Oct. 21, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase …

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First Head-to-Head Biologic Study Highlights Benefit of Vedolizumab vs. Adalimumab in Ulcerative Colitis

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced further results from the VARSITY study, which demonstrated the superiority of the gut-selective biologic vedolizumab (Entyvio®) to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira®) in achieving the primary endpoint of clinical remission* at week 52 in patients with moderately …

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FDA Approves Samsung Bioepis’ Hadlima, a Biosimilar Referencing Humira

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® i (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Please see below the …

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Salix and Mitsubishi Tanabe Pharma Enter Exclusive Agreement to Develop and Commercialize Investigational Treatment for Inflammatory Bowel Disease

BRIDGEWATER, N.J., April 25, 2019 /PRNewswire/ — Salix Pharmaceuticals (“Salix”), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, and a wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”), announced today that its affiliate has entered …

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