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Crohn’s Disease

Lilly’s Mirikizumab Met Primary Endpoint and Key Secondary Endpoints in Phase 2 Study in Patients with Crohn’s Disease

INDIANAPOLIS, May 21, 2019 /PRNewswire/ — In an oral presentation from the Digestive Disease Week medical conference in San Diego, California today, Eli Lilly and Company(NYSE: LLY) announced new safety and efficacy data for mirikizumab in patients with moderately- to severely active Crohn’s disease. Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant …

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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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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 …

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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 …

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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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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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Enterome and Takeda Enter Licensing, Co-Development and Co-Promotion Agreement for Crohn’s Disease Treatment

ENTEROME SA, a clinical-stage biotech company developing innovative therapies to treat microbiome-associated diseases with a focus on auto-immune disease and cancer, has entered into a global licensing, co-development and co-promotion agreement with Takeda Pharmaceutical Company Limited (“Takeda”). The agreement covers Enterome’s lead investigational drug candidate EB8018 in patients with Crohn’s disease, …

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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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Arena’s Olorinab Demonstrates Positive Phase 2a Results in Patients with Abdominal Pain Associated with Crohn’s Disease

SAN DIEGO, Sept. 24, 2018 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq :ARNA ) today announced positive topline results from its Phase 2a trial of olorinab, an investigational, peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 (CB2) in development for the treatment of gastrointestinal pain. Phase 2a Trial …

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