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News Breaks
December 11, 2012
08:08 EDTARIAARIAD announces 12-month data from PACE trial of ponatinib
ARIAD Pharmaceuticals announced twelve-month follow-up data from the pivotal PACE trial of ponatinib, its investigational BCR-ABL inhibitor, in heavily pretreated patients with advanced forms of chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. The study now shows that 57 percent of accelerated-phase CML patients in the trial, including 50 percent of patients with the T315I mutation, achieved a major hematologic response, the primary end-point for patients with advanced disease in the trial.
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October 24, 2014
07:37 EDTARIAARIAD announces CHMP adopts final opinion on Iclusig
ARIAD Pharmaceuticals announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted its final opinion on Iclusig following the recommendations made by the Pharmacovigilance Risk Assessment Committee earlier this month. The PRAC conducted an 11-month review of the available data on Iclusig and consulted with a scientific advisory group in oncology. This week, the EMA recommended that Iclusig continue to be used in accordance with its already approved indications as a treatment of certain leukaemias and confirmed that the benefit-risk profile of Iclusig continues to be positive in each of these indications. The EMA also recommended additional warnings in the European product information to minimize the risk of vascular events. The company said, "We are now well positioned to complete pricing and reimbursement negotiations in Europe and to ensure that Iclusig is available to appropriate Philadelphia-chromosome positive leukaemia patients."
October 10, 2014
12:11 EDTARIAOptions with increasing implied volatility
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09:00 EDTARIAOn The Fly: Pre-market Movers
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07:46 EDTARIAARIAD announces PRAC of EMA recommends Iclusig for continued EU use
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