Weekly Top News – IBD – July 8, 2019

etrasimod (APD334) / Arena
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis (clinicaltrialsregister.eu) – Jul 3, 2019 – P3; N=330; Sponsor: Arena Pharmaceuticals, Inc.

 

filgotinib (GLPG0634) / Gilead
Gilead announces intent to submit New Drug Application for filgotinib to U.S. Food and Drug Administration this year (GlobeNewswire) – Jul 2, 2019 – “Gilead Sciences, Inc….today announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about…filgotinib. The company discussed with the agency the Phase 3 FINCH studies, as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result…a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019.”

 

Humira (adalimumab) / Eisai, AbbVie
Humira pricing: $40,415/year (Infinata) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67557275; Page no: 8; REPORT TITLE: “UCB S.A. – Company Report”; AUTHOR: Infinata, et al; DATE: 07/01/2019

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Remicade pricing: $28,906/year (Infinata) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67557275; Page no: 8; REPORT TITLE: “UCB S.A. – Company Report”; AUTHOR: Infinata, et al; DATE: 07/01/2019

 

PF-06700841 / Pfizer; PF-06651600 / Pfizer
PF-06651600 + PF‑06700841 clinical trial estimate: Primary completion of P2a trial (NCT03395184) for Crohn’s disease in February 2020 (Morgan Stanley) – Jul 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 18; REPORT TITLE: “Pfizer Inc – Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi revenue projection: Guidance of $150M in H2 2019 (CrispIdea) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67508148; Page no: 3; REPORT TITLE: “Abbvie Inc – Initiating Coverage – Abbvie showing progress in its pipeline by approval of Skyrizi”; AUTHOR: Agarwal, Akansha, et al; DATE: 06/18/2019

 

ABP 710 (infliximab biosimilar) / Amgen
Amgen pulls European application for its biosimilar infliximab ABP 710 (Center for Biosimilars) – Jul 1, 2019 – “Amgen has informed the European Medicines Agency (EMA) it is withdrawing its application for ABP 710, its biosimilar infliximab (Remicade). According to the letter sent to the EMA, Amgen said the decision was due to a change in product strategy.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales estimate: $26M (consensus: $10M) in Q2 2019; Skyrizi sales projection: $221M (consensus: $147M) for FY2019 (UBS) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67522126; Page no: 1; REPORT TITLE: “Abbvie Inc First Read: Abbvie “weekly Skyrizi tracker” (Neutral) Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 06/21/2019

 

BMS-986165 / BMS
Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis (clinicaltrialsregister.eu) – Jul 3, 2019 – P2; N=120; Ongoing; Sponsor: Bristol-Myers Squibb International Corporation

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan: Newly added patent in Orange Book (Orange Book) – Jul 2, 2019 – Patent expiry on October 2, 2029  
[Screenshot]

No Comments

Post a Comment

Comment
Name
Email
Website