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Sentiment: Strong Buy
ARIAD Pharmaceuticals announced adoption of a positive opinion by the Committee for Human Medicinal Products of the European Medicines Agency on the continued availability of Iclusig in the EU for use in patients in its authorized indications. Following its review of updated clinical-trial data on Iclusig, the CHMP made a series of recommendations on measures to help minimize the risk of occlusive vascular events in patients taking Iclusig. The authorized indications of Iclusig, as approved in July, are as follows: The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. The EMA has recommended the following: Iclusig should not be used in patients with a history of heart attack or stroke, unless the potential benefits of treatment outweigh the risks. The cardiovascular status of patients should be assessed and cardiovascular risk factors actively managed before starting treatment with Iclusig. Cardiovascular status should continue to be monitored and optimised during treatment. The EMA plans to conduct a further review of the benefits and risks of Iclusig and may make additional recommendations on how Iclusig should be used.
Sentiment: Strong Buy
The Agency now plans to conduct a further in-depth review of relevant data on the benefits and risks of Iclusig and will make recommendations on whether there should be further changes to how the medicine is used.
Information to patients
Iclusig remains available as a treatment for leukaemia. However, new measures are to be taken to help reduce the risk of conditions associated with blood clots (such as heart attacks, strokes and deep vein thrombosis).
Your doctor will assess your risk of heart or circulatory problems and will take measures to reduce these risks before and during treatment with Iclusig.
If you have high blood pressure, your doctor will advise on how to reduce your blood pressure and may consider interrupting your treatment if your blood pressure remains too high.
If you have had a heart attack or stroke in the past, your doctor will carefully consider whether treatment with Iclusig is appropriate for you.
If you have been prescribed Iclusig, you should be alert for the signs and symptoms of blood clots, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and face, arm or leg weakness or numbness. In case you notice any of these signs and symptoms you should seek medical advice immediately.
Please speak to your doctor or pharmacist should you have any questions about your treatment.
Information to healthcare professionals
Following a review of the data on the risk of occlusive vascular events with Iclusig, the European Medicines Agency has concluded that healthcare professionals may continue to use ponatinib in its authorised indication with increased caution. The Agency has made the following recommendations:
Iclusig should not be used in patients with a history of heart attack or stroke, unless the potential benefits of treatment outweigh the risks.
European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a number of recommendations to help minimise the risk of blood clots obstructing arteries or veins in patients taking the leukaemia medicine Iclusig.
The CHMP recommends that Iclusig should not be used in patients who have had a heart attack or stroke in the past, unless the potential benefits to them outweigh the risks. In addition, the cardiovascular risks of all patients should be assessed and measures should be taken to reduce risks before starting and during treatment with Iclusig. Patients who have high blood pressure should have their blood pressure controlled, and treatment with Iclusig should be stopped immediately in any patient with signs of blood clots obstructing arteries or veins. Further details on these recommendations can be found below.
The CHMP’s recommendations follow a review of updated clinical trial data indicating that blood clots were occurring at a higher rate than was observed at the time of the medicine’s initial authorisation. Conditions related to blood clots, such as heart attacks and strokes, were already considered to be possible side effects of Iclusig and were listed in the EU product information.
Since the medicine’s initial approval in July 2013, its use has been limited to patients who could not be treated with other medicines of the same class, for example, because patients were intolerant to the other medicines or their disease was resistant to them.
The CHMP recommendations are broadly in line with previous advice of the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) and an opinion will be sent to the European Commission for an update of the EU product information.
Sentiment: Strong Buy
Sanofi SA ( SNY ) said Monday that it discontinued all clinical trials of an inhibitor for certain types of cancer called Fedratinib following an injunction by the U.S. Food and Drug Administration after reports that patients treated with the agent suffered a form of encephalopathy.
Sentiment: Strong Buy
ARIAD Pharmaceuticals, Inc. (ARIA) today announced that it is reducing approximately 40 percent of its staff positions in the United States following its decision to temporarily suspend the marketing and commercial distribution of Iclusig® (ponatinib) in the U.S. The reduction in U.S. staff includes positions in all major departments. This reduction in force is part of a broad program taken by ARIAD to significantly reduce its corporate operating expenses and extend its cash position. ARIAD will share details of this program when it reports third quarter financial results on Tuesday, November 12.
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