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July 7, 2014
07:02 EDTSPPISpectrum granted accelerated approval for Beleodaq from FDA
Spectrum Pharmaceuticals announced that the U.S. Food and Drug Administration has granted accelerated approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. This indication is approved under accelerated approval based on Tumor Response Rate and Duration of Response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq was approved by the FDA on July 3. This indication was approved based on data from the multi-center, single-arm BELIEF trial in 120 evaluable patients, refractory to or who had failed at least one prior systemic therapy. In this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity. A review of data from a planned confirmatory Phase III trial of Beleodaq in combination with CHOP to characterize the efficacy and safety of the Beleodaq combination versus CHOP alone, is required by FDA to convert this accelerated approval to a full approval.
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September 16, 2014
07:02 EDTSPPISpectrum issued new patent for Beleodaq for injection
Spectrum Pharmaceuticals announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8835501, which covers Beleodaq for Injection on September 16, 2014 with patent term adjustment from May 2026 to October 2027. In addition to the existing patent, covering the chemical entity of Beleodaq, this new patent covers the formulation of the product, strengthening and expanding significantly its industrial property protection.
September 9, 2014
07:01 EDTSPPISpectrum to advance SPI-2013 to Phase 3 trials
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