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July 14, 2014
07:37 EDTARIAARIAD announces continuation of Iclusig review under Article 20 procedure
ARIAD Pharmaceuticals announced that the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has provided the company with a request for limited additional information regarding Iclusig as part of its ongoing review under the Article 20 referral procedure. The PRAC has requested further information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Following ARIAD’s response and input from the agency’s Scientific Advisory Group, the company expects that the PRAC will complete its review and make final recommendations to the Committee for Medicinal Products for Human Use at its meeting in October. As we finalize our recommendations on dose modifications of Iclusig and response monitoring of patients, we will work closely with the European regulatory agency and its expert advisors so that CML patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. In March ARIAD submitted responses to initial questions outlined by the PRAC as part of the Article 20 process, which was initiated in December of last year, and responses to a second set of questions were submitted to the PRAC in June.
News For ARIA From The Last 14 Days
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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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