Regado Achieves 1,000-Patient Milestone in Phase 3 Trial of REG1
April 2, 2014REGULATE-PCI is a Phase 3 trial, recently granted Fast Track designation by the FDA, comparing REG1 to bivalirudin for superiority in reducing ischemic events in patients undergoing PCI, excluding those with ST-elevated myocardial infarction (STEMI).
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FDA Advisory Committee Unanimously Recommends Approval of Dalvance™ for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
March 31, 2014Dalvance demonstrates activity in vitro against a broad range of bacteria, including methicillin-resistant strains of Staphylococcus aureus, and if approved, would be the first drug for ABSSSI requiring only two once-weekly 30-minute intravenous doses.
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KAST Pivotal Trial Results Plus other Published Comparative Studies Show Kiva Meets or Exceeds Balloon Kyphoplasty Performance
March 24, 2014KAST pivotal trial results plus other published comparative studies show Kiva meets or exceeds balloon kyphoplasty performance, the current standard of care in treating vertebral compression fractures (VCFs), on every endpoint measured.
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