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News Breaks
July 1, 2014
05:32 EDTCTIC, BAXCTI BioPharma completes recruitment in PERSIST-1 Pacritinib Phase 3 trial
CTI BioPharma (CTIC) announced that it has completed recruitment in the PERSIST-1 pivotal Phase 3 clinical trial of pacritinib, a novel oral JAK2/FLT3 inhibitor that is being evaluated for the treatment of myelofibrosis. Under the development and commercialization agreement for pacritinib with Baxter International (BAX), CTI expects to receive a $20M development milestone payment in connection with the first treatment dosing of the last patient enrolled in PERSIST-1. CTI expects to achieve this milestone and receive payment by mid-Q3.
News For CTIC;BAX From The Last 14 Days
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July 31, 2014
14:00 EDTBAXBaxter, Halozyme announce favorable FDA panel recommendation on HyQvia
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12:39 EDTBAXFDA panel says HyQvia has favorable benefit-risk ratio, Bloomberg reports
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07:10 EDTBAXFDA Blood Products Advisory Committee to hold a meeting
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July 30, 2014
08:08 EDTBAXBaxter announces divestiture of commercial vaccines business to Pfizer for $635M
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its two commercially marketed vaccines and related production facilities to Pfizer (PFE) for a total cash consideration of $635M, subject to certain adjustments. The sale includes the company’s commercial vaccines business, which is comprised of NeisVac-C, a vaccine which helps protect against meningitis caused by group C meningococcal meningitis, and FSME-IMMUN, which helps protect against tick-borne encephalitis, an infection of the brain transmitted by the bite of ticks infected with the TBE-virus. Both vaccines are currently available outside the United States, primarily in a number of European markets. Baxter continues to explore strategic options, including the potential for partnering or divesting its R&D development programs focused on influenza and Lyme disease. Subject to regulatory approvals and other customary closing conditions, the companies expect to close the transaction by the end of 2014. Baxter expects 2014 vaccines revenues to total approximately $300M and adjusted earnings of approximately 25c per diluted share, including approximately $50M of one-time milestone payments related to the ongoing government collaborations for development of influenza vaccines. Baxter expects the transaction to be modestly dilutive to fourth quarter 2014 adjusted earnings and dilutive to 2015 adjusted earnings by approximately 15c per diluted share.
08:01 EDTBAXPfizer enters into agreement to acquire Baxter's portfolio of marketed vaccines
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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.

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