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News Breaks
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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March 25, 2015
09:29 EDTARIAARIAD reports dismissal of class action suit in federal district court
ARIAD Pharmaceuticals announced that the United States District Court for the District of Massachusetts dismissed the shareholder class action lawsuit filed in late 2013 against the company and certain of its officers, directors and underwriters in connection with the events leading up to the temporary suspension of the marketing and commercial distribution of Iclusig on October 31, 2013, and subsequent re-launch in January 2014 based on revised U.S. prescribing information and a risk evaluation and mitigation strategy. The suit alleged that certain of the company defendants made a series of false and misleading statements regarding the safety, efficacy and commercial prospects of Iclusig. The Court granted the company’s motion to dismiss the lawsuit, concluding that the plaintiffs failed to establish that any such statements violated the company’s disclosure obligations as asserted in the complaint. “We are pleased that for the second time in as many weeks, the Court has granted our motion to dismiss what we believed from the outset was another meritless lawsuit,” said Harvey J. Berger, M.D., chairman and CEO. “Our corporate values of integrity and mutual respect are always at the forefront as we continue to focus on executing our plan for sustained revenue growth and operational excellence, leading to anticipated profitability in 2018.”
March 24, 2015
09:22 EDTARIAOn The Fly: Pre-market Movers
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07:37 EDTARIAARIAD announces approval of Iclusig in Israel
ARIAD Pharmaceuticals and Medison Pharma announced that the Israeli Ministry of Health has granted regulatory approval for Iclusig, ponatinib, in Israel for 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 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. ARIAD submitted its application for Iclusig to the Israeli Ministry of Health in June 2014. Commercial launch of Iclusig is expected to occur in Q2.
March 13, 2015
13:27 EDTARIAARIAD drug granted orphan designation as GIST treatment
ARIAD Pharmaceuticals' Iclusig was granted FDA orphan status on February 12 as a treatment of gastrointestinal stromal tumors, or GIST, according to a post to the agency's site. Reference Link

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