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Crohn’s Disease

RedHill Biopharma Announces Full Results from Phase 3 Study and Supportive Top-Line Results from Open-Label Extension Study with RHB-104 in Crohn’s Disease

TEL-AVIV, Israel and RALEIGH, N.C., Oct. 11, 2019 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases, today announced  full Week 52 results for all …

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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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Takeda’s Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in its Phase 3 Crohn’s Disease Trial

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab as maintenance therapy in adult patients with moderately to severely active Crohn’s disease (CD) who achieved …

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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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