Home / Ulcerative Colitis

Ulcerative Colitis

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

OSE Immunotherapeutics Announces Publication on Anti-IL-7 Receptor Antagonist, OSE-127, in The Journal of Clinical Investigation

NANTES, France, April 11, 2019 (GLOBE NEWSWIRE) — OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE), today announced the publication of data on OSE -127, its full-antagonist monoclonal antibody targeting the interleukin-7 receptor (IL-7R), in the prestigious Journal of Clinical Investigation (JCI). The article reports on research led by the OSE Immunotherapeutics …

Read More »

Data Published in The Lancet Shows that CT-P13 is Non-inferior to Reference Infliximab in Inflammatory Bowel Disease

LONDON–(BUSINESS WIRE)–Celltrion Healthcare announced today that The Lancet has published the full data-set from its randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease (CD), the PLANETCD Study. Results from the phase III study demonstrated the non-inferiority of CT-P13 to reference infliximab in biologic-naïve patients with moderate-to-severe CD.1 CT-P13 is …

Read More »

New Phase 3 Stelara Data Show Positive Results as Maintenance Therapy in Moderate to Severe Ulcerative Colitis

COPENHAGEN, Denmark–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 3 UNIFI maintenance study. The data showed that a significantly greater proportion of adults with moderate to severe ulcerative colitis (UC) receiving ustekinumab subcutaneous (SC) maintenance therapy were in clinical remission* at Week 44, …

Read More »

Vedolizumab Achieves Superior Rates of Clinical Remission vs. Adalimumab in Head-to-Head Biologic Study in Ulcerative Colitis

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced results from the Phase 3b head-to-head VARSITY study which demonstrated that the gut-selective biologic vedolizumab (Entyvio®) was superior to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira®) in achieving clinical remission* in patients with moderately to severely active ulcerative colitis …

Read More »

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 …

Read More »