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July 21, 2014
05:12 EDTCTICCTI BioPharma announces approval of Pixuvri in Israel
CTI BioPharma announced that it has received approval from the Israeli Ministry of Health, or MOH, for Pixuvri. Pixuvri in Israel is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma who have received not more than three previous courses of treatment. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. In Israel, Pixuvri will be distributed and marketed by the Neopharm Group, Israel's second largest pharmaceuticals and health products marketer, once Pixuvri is included in the Israeli National Health Basket of drugs by the MOH. Separately, the Dutch Healthcare Authority, or NZa, and the healthcare insurance board College voor zorgverzekeringen, or CVZ, of the Netherlands have approved funding for Pixuvri as an add-on drug for patients who need a third- or fourth-line treatment option for aggressive B-cell lymphoma. This follows the inclusion of Pixuvri on the HOVON, or Haemato Oncology Foundation for Adults in the Netherlands, treatment guidelines, effective June 1. The inclusion on the Dutch list of reimbursed drugs makes Pixuvri the first registered and reimbursed medicine for the treatment of patients with multiply relapsed or refractory aggressive B-cell NHL in the Netherlands.
News For CTIC From The Last 14 Days
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October 2, 2015
17:19 EDTCTICBiotechnology Value Fund reports 5.2% passive stake in CTI BioPharma
October 1, 2015
05:31 EDTCTICCTI BioPharma, Fred Hutchinson Cancer Research Center report research fellowship
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September 24, 2015
16:35 EDTCTICCTI BioPharma announces $15.7M registered direct offering
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September 23, 2015
09:08 EDTCTICCTI BioPharma to submmit NDA for pacrtinib in Q4
CTI BioPharma announced its plan to submit a new drug application to the FDA following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The company expects to submit the NDA in Q4 and to request accelerated approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter. Submission of an NDA after a single Phase 3 trial under accelerated approval, instead of waiting to complete two Phase 3 trials, could potentially reduce time to market by up to 14 months.

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