Home / Ulcerative Colitis

Ulcerative Colitis

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 »

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 …

Read More »

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 …

Read More »

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, …

Read More »

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 …

Read More »