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News Breaks
July 15, 2013
19:14 EDTAMGNInterim results from Amgen Phase 2 study published
Amgen announced the Lancet Oncology published planned interim results from an international, open-label, Phase 2 clinical trial that is evaluating Xgeva in adults and skeletally mature adolescents diagnosed with giant cell tumor of bone. The study's primary endpoint is the safety profile of Xgeva. Secondary endpoints are the time to disease progression and the proportion of patients without any surgery at six months. Based on the investigators' interim assessment, 96% of patients with surgically unsalvageable GCTB had no disease progression after a median follow-up of 13 months. In those with salvageable GCTB whose surgery was associated with severe morbidity, 74% of patients required no surgery, and 62% of patients who had surgery underwent a less morbid procedure than planned. Overall, 72% of patients had objective tumor response, per protocol defined criteria, including 25% of patients who had an objective tumor response according to modified response evaluation criteria in solid tumors. The overall safety profile was found to be consistent with the known safety profile of Xgeva in patients with advanced cancer. Osteonecrosis of the jaw was reported in 1% of patients. Hypocalcemia adverse events, all non-serious, were reported in 5% of patients. The most common severe adverse events were low phosphate levels, back pain, pain in extremity, depression, musculoskeletal pain and anemia. Serious adverse events were reported in 9% of patients. No treatment-related deaths were reported.
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April 8, 2014
11:03 EDTAMGNPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.
April 4, 2014
09:02 EDTAMGNAmgen announces analysis results of Phase 3 trial of talimogene laherparepvec
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April 3, 2014
09:37 EDTAMGNAmgen to pay GlaxoSmithKline $275M to terminate denosumab collaboration pact
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08:27 EDTAMGNLeerink's biotech analyst holds a dinner meeting update
Biotech Analyst Liang holds an update from the AACR's Annual Meeting to discuss some of the presentations including PFE/AMGN's Palbociclib, PBYI/PFE's Neratinib, as well as other new agents for breast cancer from LLY, MDVN and CLDX, in San Diego on April 7 at 9 pm.

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