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Stelara (ustekinumab) / J&JJanssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (PRNewswire) - Oct 21, 2019 - "The Janssen Pharmaceutical Companies...announced today the U.S. Food and Drug Administration's (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission."etrasimod (APD334) / ArenaEtrasimod clinical trial estimate: Initiation of P2b/3 CULTIVATE trial for Crohn’s disease in Q4 2019 (Cantor Fitzgerald) - Oct 21, 2019 - A subscription to Thomson ONE is required to gain full access to report 68024735; Page no: 3; REPORT TITLE: "Companies, catalysts and controversies: Top questions for management at our upcoming global healthcare conference”; AUTHOR: Research Department; DATE: 09/29/2019etrolizumab (RG7413) / RocheEtrolizumab: Regulatory submissions in US/EU for Crohn's disease in 2022 or later (Roche) - Oct 16, 2019 - Q3 2019 Results [Screenshot]Stelara (ustekinumab) / J&JStelara (ustekinumab) data demonstrate long-term efficacy and safety results in adults with moderately to severely active ulcerative colitis in phase 3 extension trial (Businesswire) - Oct 21, 2019 - P3, N=399; UNIFI (NCT02407236); Sponsor: Janssen Research & Development, LLC; "The Janssen Pharmaceutical Companies...announced new two-year data from the long-term extension of the Phase 3 UNIFI study, demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis (UC). These data are being presented today as a late-breaking data presentation (LB01) at the 27th UEGW congress...Results showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission...Results from the UNITI Crohn’s disease (CD) clinical trial programme are also being presented at the congress."Alofisel (darvadstrocel) / TakedaApproved a drug with stem cells for Crohn's fistulas [Google Translation] (Webconsultas Healthcare) - Oct 18, 2019 - "Spanish researchers have discovered and developed a drug, darvadstrocel (marketed as Alofisel ), made with stem cells obtained from donor fat to treat complex perianal fistulas in patients with Crohn's disease...This medicine...is the first allogeneic cell therapy approved in Europe, is already approved by the Ministry of Health, Consumption and Social Welfare and will be funded by Social Security."BMS-986165 / BMSBMS-986165 sales projection: $2.4B in 2027 (Guggenheim) - Oct 15, 2019 - A subscription to Thomson ONE is required to gain full access to report 68074910; Page no: 19; REPORT TITLE: "3Q global pharma preview: Another solid quarter likely tempered by politics & policy”; AUTHOR: Fernandez, Seamus, et al; DATE: 10/09/2019etrasimod (APD334) / ArenaArena Pharmaceuticals' presence at United European Gastroenterology Week bolsters commitment to the gastrointestinal disease community (Arena Press Release) - Oct 18, 2019 - "Arena Pharmaceuticals, Inc...will present new open-label extension data from the Phase 2 OASIS trial for its investigative drug candidate etrasimod...in patients with moderately to severely active ulcerative colitis (UC) at the 25th Annual United European Gastroenterology (UEG) Week...UEG Week is taking place October 19-23, 2019, in Barcelona, Spain."etrasimod (APD334) / ArenaEtrasimod US sales projection: $665M peak for ulcerative colitis (Cantor Fitzgerald) - Oct 21, 2019 - A subscription to Thomson ONE is required to gain full access to report 68047432; Page no: 2; REPORT TITLE: "Arena Pharmaceuticals Inc - Management dinner takeaways”; AUTHOR: Research Department; DATE: 10/03/2019Otezla (apremilast) / AmgenOtezla WW revenue projection: $1,917M in 2019 (Jefferies) - Oct 19, 2019 - A subscription to Thomson ONE is required to gain full access to report 68079059; Page no: 30; REPORT TITLE: "Q3 EPS and thoughts into year-end”; AUTHOR: Yee, Michael, et al; DATE: 10/10/2019Rinvoq (upadacitinib) / AbbVie; Xeljanz (tofacitinib) / PfizerIn a U-turn, ICER takes more positive view of AbbVie’s Rinvoq (PMLive) - Oct 14, 2019 - "The Institute for Clinical and Economic Review (ICER) has shifted its position on the value of AbbVie’s Rinvoq (upadacitinib), bringing the rheumatoid arthritis drug under its quality-adjusted life-year (QALY) threshold....ICER has changed some of the parameters and inputs for the value models described in the report...Under the revised model, the incremental QALY for Rinvoq versus Humira came in at $92,000, below the $150,000 threshold used by ICER....Notably, the statement that Rinvoq ‘provided marginal clinical benefit...The revised report also retains a skeptical view about the value of Xeljanz and Olumiant....One of ICER’s independent committees will discuss the document and hold a vote on it in December."
