Weekly Top News – IBD – July 1, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from induction part of P3 Diversity1 trial (NCT02914561) for crohn’s disease at end of 2020/early 2021 (Kepler Cheuvreux) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67505266; Page no: 16; REPORT TITLE: “Belgian Life Science Day”; AUTHOR: Landemaine, Thomas, et al; DATE: 06/17/2019

 

etrasimod (APD334) / Arena
ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Jun 24, 2019 – P3; N=330; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: 10-week induction part data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in H2 2019; 58-week maintenance part data from P2b/3 SELECTION1 trial for ulcerative colitis in H1 2020 (Kepler Cheuvreux) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67505266; Page no: 16; REPORT TITLE: “Belgian Life Science Day”; AUTHOR: Landemaine, Thomas, et al; DATE: 06/17/2019

 

Stelara (ustekinumab) / J&J
Stelara: “The Committee discussed the issues identified in this application, mainly relating to the wording of the indication and the target population [treatment of adult patients with moderately to severely active ulcerative colitis].” (EMEA) – Jun 26, 2019 – CHMP Final Minutes for the meeting on 23-26 April 2019: “The Committee adopted a request for supplementary information with a specific timetable.”

 

Entyvio (vedolizumab) / Takeda
Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn’s Disease] (clinicaltrials.gov) – Jun 28, 2019 – P; N=300; Not yet recruiting; Sponsor: Takeda

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan exclusivity expiry: 2028 (Zacks) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67412332; Page no: 3; REPORT TITLE: “Bausch Health Cos Inc.(BHC) Zacks company report”; AUTHOR: Research Department; DATE: 05/29/2019

 

vidofludimus (IMU-838) / Immunic
Immunic, Inc. to present previously unpublished data regarding lead program, IMU-838, at the GI Inflammatory Diseases Summit in Boston (PRNewswire) – Jun 24, 2019 – “Immunic…announced that Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present today previously unpublished data regarding the company’s lead program, IMU-838, at the GI Inflammatory Diseases Summit (GIIDS) in Boston….Preclinical data shows that IMU-838 appears selective towards those T cells producing high amounts of the pro-inflammatory cytokines, IFNγ and IL-17….In a phase 2a clinical study in steroid dependent UC and Crohn’s disease patients, the active moiety of IMU-838 (vidofludimus) has shown activity in the ability to wean off steroids, with a total response rate of 88.5%.”

 

Entyvio (vedolizumab) / Takeda
Entyvio: Expiry of patents in US in September 2021 and EU in August 2022 (Takeda) – Jun 29, 2019 – Annual Report 2018: Regulatory data protection in EU until May 2024 and US until May 2026; Re-examination period in Japan until July 2026  
[Screenshot]

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan pricing: $30,000/year in US (J.P. Morgan) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67441460; Page no: 17; REPORT TITLE: “Axcella Health Inc- Initiating coverage- Axcella: No Axcella to grind; Initiating at overweight”; AUTHOR: FYE, Jessica, et al; DATE: 06/03/2019

 

Kappaproct (cobitolimod) / InDex
InDex Pharmaceuticals enrolls last patient in phase IIb study CONDUCT with cobitolimod (PRNewswire)- Jun 26, 2019 – P2b, N=215; CONDUCT (NCT03178669); Sponsor: InDex Pharmaceuticals; “InDex Pharmaceuticals…announced that patient enrolment was completed in the dose optimisation study CONDUCT, which is evaluating cobitolimod for the treatment of moderate to severe ulcerative colitis. Top line results are expected to be available in 8-10 weeks.”

No Comments

Post a Comment

Comment
Name
Email
Website