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News Breaks
June 3, 2014
10:51 EDTNVS, INCYNovartis, Incyte announce results from RESPONSE trial evaluating ruxolitinib
Novartis (NVS) and Incyte (INCY) announced results from the first-ever pivotal Phase III study evaluating a JAK 1/2 inhibitor for the treatment of polycythemia vera. Jakavi, or ruxolitinib, improved hematocrit control without the need for phlebotomy and reduced spleen size in patients with PV who are resistant to or intolerant of hydroxyurea[. Findings are being presented at the 50th Annual Meeting of the American Society of Clinical Oncology. Ruxolitinib was well tolerated and adverse events were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis. Within the first 32 weeks of treatment, Grade 3 or 4 hematologic AEs in the ruxolitinib treatment arm were anemia and thrombocytopenia and fewer patients treated with ruxolitinib experienced thromboembolic events when compared to those who received best available therapy. The most common non-hematologic AEs were headache, diarrhea and fatigue. Additionally, 3.6% of patients randomized to the ruxolitinib treatment arm discontinued treatment due to AEs compared to 1.8% on the best available therapy arm. Data from the RESPONSE trial will support worldwide regulatory submissions planned this year.
News For NVS;INCY From The Last 14 Days
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October 23, 2014
11:57 EDTNVSNovartis management to meet with Jefferies
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05:21 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies in AS
Novartis announced that AIN457 met primary and key secondary endpoints in two pivotal Phase III studies, MEASURE 1 and MEASURE 2, in patients with ankylosing spondylitis, or AS. Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin- 17A, a protein that is central to the development of inflammatory diseases, including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress. Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate- to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.
October 22, 2014
07:44 EDTNVSGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
October 21, 2014
07:54 EDTINCYLeerink a buyer of Alkermes, ImmunoGen, Incyte
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07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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08:01 EDTINCYIncyte names Gryska CFO to succeed Hastings
Incyte announced the appointment of David Gryska as Executive Vice President and CFO, effective October 31. Gryska will succeed David Hastings, who has served as Incyte’s Executive Vice President and CFO since October 2003. Hastings, who is leaving the company to pursue other opportunities, will remain with Incyte through the end of November and will work closely with Gryska to ensure a seamless transition.
October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
October 14, 2014
11:23 EDTNVSBIND Therapeutics and The Conference Forum hold a conference
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