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News Breaks
June 2, 2014
07:48 EDTAMGNAmgen presents new data that support potential of talimogene laherparepvec
Amgen announced new data from two key clinical trials that support the potential of talimogene laherparepvec, a novel, investigational oncolytic immunotherapy, as both a single agent and as part of a combination regimen in patients with metastatic melanoma. Data from the 19 patients in the Phase 1b combination study showed no dose-limiting toxicities with talimogene laherparepvec in combination with ipilimumab. Additionally, tumors either shrank in size or were no longer detectable in 56 percent of patients when talimogene laherparepvec was given prior to and in combination with ipilimumab. The most common adverse events observed were chills, fevers, rash and fatigue. The pivotal Phase 3 trial met its primary endpoint showing a statistically significant improvement in durable response rate. Detailed results of the overall survival analysis, a key secondary endpoint of the pivotal Phase 3 trial evaluating talimogene laherparepvec as a single agent, were also presented. The results demonstrated a 4.4 month improvement in overall survival which closely approached statistical significance in the total patient population tested that included patients with and without visceral tumors.The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.
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February 26, 2015
16:35 EDTAMGNAmgen reports EMA acceptance of Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced that the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application, or MAA, of Kyprolis for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA. Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe. Nearly all patients with the disease experience periods of remission, followed by relapses and eventually their disease becomes resistant to treatment. The MAA includes data from the Phase 3 ASPIRE trial as well as other relevant data.
February 25, 2015
16:50 EDTAMGNAmgen reports positive results from head-To-head Phase 3 study
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February 17, 2015
18:17 EDTAMGNJANA Partners gives quarterly update on stakes
NEW STAKES: NCR (NCR), Liberty Ventures (LVNTA), Solarcity (SCTY), Computer Sciences Corp (CSC), Salix (SLXP), and Applied Materials (AMAT). INCREASED STAKES: Hertz (HTZ), Valeant (VRX), Walgreens Boots Alliance (WBA), Rackspace (RAX), and HD Supply (HDS). DECREASED STAKES: AIG (AIG), Actavis (ACT), Charter (CHTR), AerCap (AER), and Energy Transfer Equity (ETE). LIQUIDATED STAKES: Equinix (EQIX), Cameron International (CAM), Dollar General (DG), QEP Resources (QEP), and Amgen (AMGN).
10:01 EDTAMGNCVS says PCSK9 inhibitors could cost system $150B annually
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February 13, 2015
17:52 EDTAMGNThird Point gives quarterly update on stakes
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08:23 EDTAMGNPiper Jaffray biotech/healthcare analysts hold analyst/industry conference call
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