GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for Benlysta®...
GlaxoSmithKline (GSK) and JSC Binnopharm (Binnopharm) announced an alliance to enable the local secondary manufacture of a number of GSK vaccines in Russia. The agreement was signed in Moscow during the session of the Russian-British Intergovernmental Steering Committee (ISC) for Trade and...
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the start of a Phase III study in patients with indolent B-cell non-Hodgkin's lymphoma (B-NHL) who did not respond to or progressed during, or within 6 months of a rituximab containing regimen. Under the terms of Genmab's collaboration...
GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). A priority review designation is granted to...
The National Comprehensive Cancer Network (NCCN) has been awarded two individual $2 million grants from GlaxoSmithKline (GSK) to support clinical studies of ofatumumab (Arzerra®, GlaxoSmithKline) in the treatment of hematologic malignancies and pazopanib (Votrient®, GlaxoSmithKline) in the...
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™(gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic...
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™(gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic...
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™(gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic...