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Weekly Top News – IBD – November 4, 2019

November 4, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib launch estimate: 2021 for ulcerative colitis and Crohn’s disease (Credit Suisse) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183641; Page no: 31; REPORT TITLE: “First edition – US Alert: Friday, October 25, 2019”; AUTHOR: Product Marketing, Credit Suisse G, et al; DATE: 10/25/2019

 

Xeljanz (tofacitinib) / Pfizer
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019 (EMEA) – Oct 31, 2019 – “The PRAC concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk. The PRAC recommended that Xeljanz should be used with caution in patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk…Patients older than 65 years of age should be treated with Xeljanz only when there is no other appropriate treatment.”

 

filgotinib (GLPG0634) / Gilead
Filgotinib US sales projection: $35M in 2021, $80M in 2022, $165M in 2023 and $300M in 2024 to Gilead (Cowen & Co) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68178826; Page no: 4; REPORT TITLE: “Gilead Sciences Inc – Q3 In-line, guidance narrowed; Boring is ok, though it won’t drive a re-rating”; AUTHOR: Nadeau, Phil, et al; DATE: 10/24/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan patent expiry: 2024/2025 related to composition-of-matter (Cowen & Co) – Nov 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183642; Page no: 30; REPORT TITLE: “Bausch Health Companies Inc – Initiating Coverage Initiation: Transformed & diversified, Bausch Health should slowly grind higher”; AUTHOR: Cacciatore, Ken, et al; DATE: 10/25/2019

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: July 2024 in EU (Kepler Cheuvreux) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68195721; Page no: 1; REPORT TITLE: “Formycon AG Espresso Note | Formycon | Buy | start of phase I for FYB202”; AUTHOR: Choplain, Damien, et al; DATE: 10/28/2019

 

etrolizumab (RG7413) / Roche
Open-Label Extension and Safety Study for Patients With Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (clinicaltrials.gov) – Oct 31, 2019 – P3; N=900; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Apr 2024 –> Oct 2025; Trial primary completion date: Apr 2024 –> Oct 2025

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma to present new phase 3 data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting (GlobeNewswire) – Oct 28, 2019 – “RedHill Biopharma Ltd…announced that two oral presentations and two posters on two of the Company’s leading drug candidates, RHB-1051 (Talicia®, H. pylori infection) and RHB-104 (Crohn’s disease) will be presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting, being held October 25-30, in San Antonio, Texas.”

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan US patent expiry: July 2029 (Cowen & Co) – Nov 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183642; Page no: 31; REPORT TITLE: “Bausch Health Companies Inc – Initiating Coverage Initiation: Transformed & diversified, Bausch Health should slowly grind higher”; AUTHOR: Cacciatore, Ken, et al; DATE: 10/25/2019

 

Rinvoq (upadacitinib) / AbbVie
A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies (clinicaltrials.gov) – Oct 30, 2019 – P3; N=501; Recruiting; Sponsor: AbbVie; Trial completion date: Mar 2022 –> Sep 2021; Trial primary completion date: Mar 2022 –> Sep 2021

 

Entyvio SC (vedolizumab SC) / Takeda
Douglas Wolf, MD: Vedolizumab subcutaneous treatment for ulcerative colitis (MD Magazine) – Nov 3, 2019 – “The biological license application to the FDA has already been submitted and things are in the works for approval of subcutaneous ENTYVIO. That approval is anticipated in in 2020. It may be early in 2020, it may be in the middle of 2020, it’s not absolutely unknown.”

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