Specialty Pharma Journal Specialty, Precision & Technology
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, …
Tag Archives: Crohn’s disease
October, 2018
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8 October
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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5 October
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 …
September, 2018
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25 September
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 …
June, 2018
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7 June
Microbiotica Enters into Microbiome Collaboration with Genentech
CAMBRIDGE, England–(BUSINESS WIRE)–Microbiotica, a leading player in microbiome-based therapeutics spun out of the Wellcome Sanger Institute, today announced that it has entered into a multi-year strategic collaboration with Genentech, a member of the Roche Group, to discover, develop and commercialise biomarkers, targets and medicines for inflammatory bowel disease (IBD). Under …
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5 June
Data Shows Treatment with Janssen’s Stelara Reduced Rates of Hospitalization and Surgery in Moderate-to-Severe Crohn’s Disease
WASHINGTON DC–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson announced today a new analysis looking at two-year data from the IM-UNITI long-term extension (LTE) STELARA® (ustekinumab) programme, which demonstrated that two dosing regimens of ustekinumab (90mg administrated every 12 [q12w] and 8 [q8w] weeks), can decrease the risk of Crohn’s …
January, 2018
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5 January
Takeda Announces Intention to Acquire Cell Therapy Firm TiGenix
Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced its intention to acquire TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”), an advanced biopharmaceutical company developing novel stem cell therapies for serious medical conditions, and as a result has entered into an offer and support agreement with TiGenix which provides …
December, 2017
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15 December
FDA Approves Pfizer’s Ixifi, a Biosimilar to Remicade
Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved IXIFI as …
October, 2017
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30 October
One Year Maintenance and Switching Data in Patients with Crohn’s Disease Support the Use of Inflectra in IBD
NEW YORK–(BUSINESS WIRE)–New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period.1The full 54-week results of the randomized controlled trial comparing INFLECTRA and REMICADE in biologic-naïve patients …
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19 October
Celgene Discontinues GED-0301 Inflammatory Bowel Disease Program
SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) today announced that the GED-0301 (mongersen) phase III REVOLVE trial (CD-002) in Crohn’s disease (CD) and the extension trial (SUSTAIN, CD-004) will discontinue. Celgene has decided to stop the trials following an October recommendation of the Data Monitoring Committee, which assessed overall benefit/risk during …