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Abivax’s ABX464 shows ‘impressive’ efficacy in severe ulcerative colitis patients
pharmatimes
May 27, 2021
French biotech company Abivax has revealed positive topline results from a Phase IIb study of its investigational oral drug candidate ABX464 in ulcerative colitis (UC) patients.
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Stelara® “a compelling option” for the treatment of Crohn’s disease
europeanpharmaceuticalreview
May 25, 2021
Janssen has released abstracts for four studies evaluating Stelara® (ustekinumab) in Crohn’s disease (CD) and ulcerative colitis (UC).
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Lilly’s mirikizumab hits primary endpoint in ulcerative colitis study
pharmatimes
March 18, 2021
Eli Lilly’s anti-IL-23p19 monoclonal antibody (mAb) mirikizumab has met the primary endpoint and all key secondary endpoints in a Phase III ulcerative colitis (UC) study.
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HUMIRA Receives FDA Approval to Treat Pediatric Patients with Ulcerative Colitis
americanpharmaceuticalreview
March 02, 2021
AbbVie announced the U.S. Food and Drug Administration (FDA) approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.
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Upadacitinib meets all endpoints in Phase III ulcerative colitis trial
europeanpharmaceuticalreview
February 24, 2021
In the trial, 74 percent of participants responded to upadacitinib and 33 percent of patients achieved clinical remission.
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Ulcerative Colitis GSK2831781 Study Discontinued
americanpharmaceuticalreview
January 28, 2021
Immutep Limited is advising its licensing partners, GSK, has discontinued its Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody, GSK2831781 (derived from Immutep’s IMP731 antibody), in patients with active ulcerative ...
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Upadacitinib Meets Primary, All Ranked Secondary Endpoints in Ulcerative Colitis Study
americanpharmaceuticalreview
December 10, 2020
AbbVie announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints ...
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EMA begins evaluation of filgotinib for ulcerative colitis
pharmatimes
November 05, 2020
Gilead and Galapagos’ application seeking approval for their oral JAK1 inhibitor filgotinib as a treatment for ulcerative colitis has been validated by the European Medicines Agency (EMA).
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First-in-human trial to study remestemcel-L as Crohn’s disease therapy launched
europeanpharmaceuticalreview
October 28, 2020
A Phase I clinical trial of remestemcel-L delivered by an endoscope to patients with Crohn’s disease and ulcerative colitis has commenced.
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Zydus Cadila gets tentative USFDA nod for Tofacitinib ER tablets
expresspharma
October 21, 2020
Zydus Cadila has received tentative approval from the USFDA to market Tofacitinib Extended-Release Tablets, 11 mg (US RLD: Xeljanz XR Tablets).