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March 2, 2013
16:09 EDTCELGCelgene presents results from 1st phase III study in psoriasis ESTEEM 1
Celgene International Sàrl, a subsidiary of Celgene presented the results from ESTEEM 1, the Company’s first phase III study in psoriasis, at the American Academy of Dermatology annual meeting in Miami, Florida. The company previously announced statistical significance for the primary and major secondary endpoint of PASI-75 at Week 16 and the Static Physician Global Assessment for patients receiving apremilast in the ESTEEM 1&2 phase III studies. ESTEEM 1&2 are the phase III registrational randomized, placebo-controlled studies evaluating the company’s oral small-molecule inhibitor of phosphodiesterase-4 in patients with moderate-to-severe chronic plaque psoriasis. Statistical significance at week 16 was also demonstrated in the major secondary endpoint, Static Physician Global Assessment (sPGA) of clear or almost clear (P<0.0001), and other key secondary endpoints (change in BSA, Pruritus VAS, DLQI), as well as in assessments of difficult to treat areas (nail and scalp psoriasis). An NDA submission to the U.S. Food and Drug Administration, based on the combined ESTEEM 1&2 studies for psoriasis, is expected in the second half of 2013. The Company previously announced it expects to file a separate NDA for psoriatic arthritis in the first quarter of 2013. A combined PsA/psoriasis MAA submission in Europe is also planned for the second half of 2013.
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October 20, 2014
13:26 EDTCELGCelgene I&I franchise boosted by Crohn’s trial data, says William Blair
William Blair said it views the preliminary Phase II efficacy and safety data from mongersen in Crohn’s disease reported by Celgene as encouraging. The firm noted that the 10 mg arm did not achieve significance, but the three data points collectively formed a robust dose-response that William Blair said lends support for the drug's proposed mechanism of action. William Blair believes mongersen complements Celgene’s Inflammation & Immunology portfolio and the firm maintains its Outperform rating on the stock, which is up 4% to $91.65 in afternoon trading.
13:21 EDTCELGCelgene reports Phase II data in Crohn’s Disease to be presented at UEG
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October 17, 2014
13:18 EDTCELGLeerink's biotech analyst holds an analyst/industry conference call
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October 16, 2014
15:10 EDTCELGAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
October 10, 2014
08:41 EDTCELGCelgene reports apremilast significantly improved preexisting psoriasis in study
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08:39 EDTCELGCelgene says data show Apremilast treatment resulted in improved quality of life
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October 8, 2014
07:11 EDTCELGEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.
October 7, 2014
07:31 EDTCELGCelgene to present long-term efficacy and safety data on oral Otezla
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, announced that the latest research findings on OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in plaque psoriasis and psoriatic arthritis will be presented at the 23rd European Academy of Dermatology and Venereology Congress in Amsterdam, October 8 – 12. In total, 11 abstracts will be presented at the meeting. OTEZLA data to be presented include long-term results from Celgene’s pivotal trial, ESTEEM 2 and pooled analyses of safety and tolerability results from the ESTEEM 1 and 2 studies in patients with moderate to severe plaque psoriasis. Additional analyses will evaluate the effect of OTEZLA on pruritus, difficult-to-treat areas such as nail and scalp, and palmoplantar psoriasis, work productivity and improvements in health-related quality of life. An analysis of long-term results from the PALACE clinical trial program evaluating OTEZLA in patients with active psoriatic arthritis will also be presented at the meeting. The analysis assesses the effect of OTEZLA treatment through 52 weeks on the signs and symptoms of psoriatic arthritis, including enthesitis and dactylitis in patients with pre-existing enthesitis or dactylitis.
07:24 EDTCELGAlliance for Regenerative Medicine
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