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June 1, 2014
15:40 EDTAMGNAmgen announces Phase 2 results of Vectibix study
Amgen announced results from the Phase 2 PEAK study that reinforce the improved overall survival, OS, benefit of panitumumab, Vectibix, when used in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, compared to bevacizumab, Avastin, plus FOLFOX as first-line treatment in patients with wild-type RAS metastatic colorectal cancer, mCRC. The data was presented today at the 50th Annual Meeting of the American Society of Clinical Oncology,ASCO, in Chicago.The data presented at ASCO was an extended analysis of the PEAK study that supports the use of panitumumab in combination with FOLFOX for patients with wild-type RAS mCRC. In this exploratory analysis, patients who received panitumumab plus FOLFOX and were then treated with a VEGF inhibitor-based treatment had a median OS improvement of 41.3 months. By comparison, patients who received bevacizumab plus FOLFOX and were then treated with an anti-EGFR inhibitor-based treatment, had a median OS improvement of 29.0 months. For both arms, outcomes were similar to those observed in the overall treated population with wild-type RAS mCRC. "The initial PEAK data reinforce the potential importance of panitumumab for select patients, but we wanted to evaluate whether this benefit was dependent on administration with FOLFOX and if other subsequent treatments might impact survival outcomes," said Fernando Rivera, M.D., Medical Oncology Department, Hospital Universitario Marques de Valdecilla, Santander, Spain, and a lead investigator in the study. "These data suggest that a front-line treatment strategy with panitumumab in combination with FOLFOX may offer clinical benefit in patients with wild-type RAS metastatic colorectal cancer compared to bevacizumab-based regimens in this treatment setting."
News For AMGN From The Last 14 Days
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September 22, 2014
09:02 EDTAMGNAmgen submits BLA to the FDA for immunotherapy blinatumomab
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September 17, 2014
08:03 EDTAMGNAmgen price target raised to $151 from $143 at Morgan Stanley
Morgan Stanley raised Amgen's price target to $151 based on increased brodalumab and AMG 416 expectations. Shares are Overweight rated.
September 15, 2014
16:40 EDTAMGNAmgen trial finds Prolia treatment enables non-osteoporotic T-scores
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16:05 EDTAMGNAmgen says romosozumab treatment increases bone mineral density
Amgen and UCB announced results from several exploratory analyses of the Phase 2 study evaluating romosozumab in postmenopausal women with low bone mineral density, BMD. Romosozumab is an investigational bone-forming agent that is designed to work by inhibiting the protein sclerostin, thereby increasing bone formation and decreasing bone breakdown. These data were presented at the American Society for Bone and Mineral Research, ASBMR, 2014 Annual Meeting in Houston, Sept. 12-15. "Fractures or broken bones due to osteoporosis are very common and often have a life altering impact on an older woman and her family," said Michael McClung, M.D., director of the Oregon Osteoporosis Center. "It is encouraging to see that treatment with romosozumab for a second year provided additional increases in bone mineral density beyond what was seen during the first 12 months of treatment." "Despite continuing progress in the management and treatment of patients with osteoporosis, there remains a considerable need for new therapeutic approaches for individual patients," said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB. "Investigational studies to date suggest that the bone building capacity of romosozumab may show promise as a new treatment option to manage this serious disease. We look forward to reporting the results of the romosozumab Phase 3 program in 2016."
07:21 EDTAMGNHeart Failure Society of America to hold annual meeting
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05:12 EDTAMGNAmgen presents analyses of Phase 3 ivabradine data for treatment of chronic HF
Amgen announced data from the Phase 3 Systolic Heart failure treatment with the If inhibitor ivabradine Trial, or SHIFT, study evaluating ivabradine in patients with chronic heart failure, or HF, were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America, or HFSA, in Las Vegas. A post-hoc analysis from the SHIFT study confirmed low systolic blood pressure, or SBP, is associated with poor outcomes in chronic HF, and that ivabradine reduced the primary composite endpoint of cardiovascular death or hospitalization for worsening HF in this subgroup with low baseline SBP. Safety was similar across the three SBP groups. Results were published in the July 2014 issue of the European Journal of Heart Failure. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said, "Despite standard of care, chronic heart failure remains a disabling condition with a poor prognosis for patients at risk for hospitalization. Analyses from the pivotal SHIFT study complement the main trial findings that form the basis of our U.S. submission package for ivabradine. We recently received a priority review designation for ivabradine from the FDA and are working with the agency to potentially bring this important treatment option to certain patients with chronic heart failure in the U.S. as soon as possible."
September 14, 2014
13:39 EDTAMGNFurther gains in Amgen could be subdued, Barron's says
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September 12, 2014
07:14 EDTAMGNAmerican Society for Bone & Mineral Research holds annual meeting
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