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ontamalimab (SHP647) / TakedaEuropean Commission releases Takeda from commitment to divest Shire’s pipeline compound SHP647 (Businesswire) - May 28, 2020 - Takeda will discontinue the current SHP647 clinical trial program, and it will be providing all eligible trial participants with the opportunity to have continued access to SHP647 in a post-trial access ('PTA') study. In addition, subject to obtaining trial participant consents and the satisfaction of regulatory and ethical considerations, Takeda will make SHP647 clinical trial data and biosamples available to the scientific community through the Crohn’s & Colitis Foundation....Takeda will no longer develop the SHP647 compound in any inflammatory bowel disease indication, including Ulcerative Colitis or Crohn’s Disease."
etrasimod (APD334) / ArenaArena completes full enrollment of etrasimod phase 2 ADVISE trial for atopic dermatitis, provides program updates (Arena Press Release) - May 26, 2020 - "Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing and on track; ELEVATE UC 12 Phase 3 trial expected to initiate in H2 2020; topline data for both trials expected by year end 2021...Etrasimod CULTIVATE Phase 2b dose-ranging trial in Crohn's disease (CD) initiated and ongoing; considering options to help facilitate availability of topline data in 2021; withdrawing previously announced overall program guidance based on expected COVID-19 impact on trial execution including site activation and enrollment...Olorinab CAPTIVATE Phase 2b trial in abdominal pain associated with irritable bowel syndrome (IBS-C, IBS-D) ongoing; experiencing some COVID-19 related impact on trial enrollment; topline data expected between Q4 2020 and Q1 2021..."
ontamalimab (SHP647) / TakedaEU regulators allow Takeda to buy Shire without selling asset (Reuters) - May 28, 2020 - "Japan’s Takeda Pharmaceutical Co Ltd (4502.T) will not be required to sell a biologic drug, a concession made to address EU antitrust concerns over its 2018 bid to buy Shire, because market condition have changed, EU regulators said on Thursday....'On this basis, the Commission concluded that the combination of the above developments amounted to exceptional circumstances so that the divestment of SHP 647 was no longer necessary to render Takeda’s acquisition of Shire compatible with the internal market,' the EU competition enforcer said."
Rinvoq (upadacitinib) / AbbVieU-ACHIEVE: A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - May 27, 2020 - P3; N=844; Recruiting; Sponsor: AbbVie; Trial primary completion date: Apr 2021 --> Oct 2021
Entyvio (vedolizumab) / TakedaVedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) (clinicaltrials.gov) - May 29, 2020 - P2; N=90; Completed; Sponsor: Takeda; Active, not recruiting --> Completed
ravagalimab (ABBV-323) / AbbVieA Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - May 29, 2020 - P2; N=40; Recruiting; Sponsor: AbbVie; N=30 --> 40; Trial completion date: Nov 2021 --> Aug 2022
