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News Breaks
March 2, 2013
16:09 EDTCELGCelgene presents results from 1st phase III study in psoriasis ESTEEM 1
Celgene International Sŕrl, 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.
News For CELG From The Last 14 Days
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January 23, 2015
07:21 EDTCELGCelgene receives positive CHMP opinion for ABRAXANE
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January 21, 2015
08:36 EDTCELGCelgene price target raised to $139 from $115 at RW Baird
Baird raised its price target on Celgene to $139 from $115 following last week's guidance from the company. Baird reiterated its Outperform rating on Celgene shares.
January 16, 2015
09:11 EDTCELGCelgene says oral Otezla approved by European Commission in 2 indications
Celgene International, a wholly-owned subsidiary of Celgene Corporation, announced that the European Commission has granted marketing authorisation for OTEZLA, the company’s oral selective inhibitor of phosphodiesterase 4, in two therapeutic indications: For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light. Alone or in combination with Disease Modifying Antirheumatic Drugs, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. The marketing authorization is based on efficacy and safety data from two Phase III programs, ESTEEM AND PALACE, which demonstrate a maintained clinical response among patients with psoriasis and psoriatic arthritis treated with OTEZLA through 52 weeks, across multiple endpoints. The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use in November 2014.12 OTEZLA will be launched in the European Union in the coming months in accordance with local requirements.
January 15, 2015
07:59 EDTCELGAmerican Society of Clinical Oncology to hold a symposium
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