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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.
News For AMGN From The Last 14 Days
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November 25, 2015
16:01 EDTAMGNAmgen submits Biologics License Application to FDA for ABP 501
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November 24, 2015
05:42 EDTAMGNAmgen announces EU approval of Blincyto
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November 23, 2015
14:10 EDTAMGNAmgen's PCSK9 inhibitor Repatha gets exclusive deal with CVS
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November 22, 2015
15:03 EDTAMGNMerck reports multiple data sets from Keytruda combination studies
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November 19, 2015
16:06 EDTAMGNAmgen's Kyprolis approved for multuple myeloma by European commission
Amgen announced the European Commission granted marketing authorization for Kyprolis in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The EC approved Kyprolis based on data from the pivotal Phase 3 ASPIRE trial. The study showed that patients treated with Kyprolis in combination with lenalidomide and dexamethasone had increased median time to progressive disease or death by 8.7 months compared to patients treated with lenalidomide and dexamethasone. Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC. Amgen plans to submit data from the Phase 3 ENDEAVOR trial for potential authorization of Kyprolis in combination with dexamethasone in the EU. This data also serves as the basis of the supplemental New Drug Application of Kyprolis in combination with dexamethasone for patients with relapsed multiple myeloma, which has been accepted for priority review by the FDA.
November 16, 2015
16:05 EDTAMGNAmgen to present eight IMLYGIC abstracts
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