Press releases
Reports of narcolepsy in Europe following vaccination with Pandemrix™
GSK initially became aware of possible cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix through adverse event reports received by the Swedish Medical Products Agency, and subsequently via media reports in Finland.
GSK and Valeant announce new U.S. FDA PDUFA goal date for ezogabine
GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine* to 30 November 2010. The original goal date was 30 August 2010.
GSK commences Phase III clinical trials to develop herpes zoster vaccine for the prevention of shingles
GlaxoSmithKline confirmed today that the company has commenced the Phase III clinical trials programme of its candidate herpes zoster vaccine currently being developed for the prevention of shingles. The phase III clinical trials will study more than 30,000 patients globally and will evaluate the efficacy, safety and immunogenicity of the candidate vaccine.
GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus
GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. today 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 drugs that, if approved, offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA has assigned belimumab a Prescription Drug User Fee Act (PDUFA) target date of 9 December 2010.
GSK and Genmab announce topline results from the concluded pivotal trial of Arzerra (ofatumumab) in fludarabine and alemtuzumab refractory chronic lymphocytic leukemia
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today top line results from the concluded pivotal trial of ofatumumab in patients with fludarabine and alemtuzumab refractory chronic lymphocytic leukemia (CLL).
Image of new antibiotic in action opens up new opportunities to combat antibacterial resistance
Detailed pictures have been published today showing how a new type of experimental antibiotic can kill bacteria already resistant to existing treatments.1 The findings could ultimately help scientists to develop new antibiotics to tackle the bacteria responsible for many hospital and community-acquired infections.
GSK exercises option on Anacor’s novel antibiotic for the treatment of gram-negative infections
GlaxoSmithKline PLC (GSK) and Anacor Pharmaceuticals today announced that GSK has exercised its option to obtain an exclusive licence to develop and commercialise GSK2251052 (GSK ‘052), formerly known as AN3365. GSK ‘052 is a novel, systemic antibiotic derived from Anacor’s boron chemistry platform.
GSK receives CHMP positive opinion for a new indication for Arixtra
GlaxoSmithKline (GSK) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arixtra (fondaparinux),an anti-clotting drug (antithrombotic) for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs without concomitant deep-vein thrombosis.
GSK announces Q2 results for 2010
Q2 EPS before major restructuring* 2.6p (29.3p excluding pre-announced legal charge)
GlaxoSmithKline statement in response to FDA announcement on TIDE trial
GlaxoSmithKline [NYSE: GSK] confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA review of recommendations from its Advisory Committee meeting July 13-14. Patients already enrolled may continue in the trial.
