GSK initiates phase III programme for novel type 2 diabetes medication, Syncria® (albiglutide)
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- Category: GlaxoSmithKline
GlaxoSmithKline has announced initiation and dosing of the first patient of the Phase III clinical trial programme to evaluate the efficacy, safety and tolerability of the investigational GLP-1 (Glucagon-like peptide 1) agonist Syncria® (albiglutide) in men and women with type 2 diabetes. The Phase III programme will include more than 4,000 patients.
FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab
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- Category: Amgen
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted Amgen's submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women and treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer.
Bristol-Myers Squibb Foundation to Bridge Gaps in Hepatitis C Awareness, Prevention and Care
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- Category: Bristol-Myers Squibb
The Bristol-Myers Squibb Foundation has announced funding of more than $1.17 million, focused on hepatitis C prevention and education and the mitigation of the disease in China, India, and Taiwan. The funding is part of Delivering Hope, an umbrella program for Bristol-Myers Squibb's (NYSE: BMY) efforts in the areas of hepatitis awareness, prevention and care. Organizations receiving funding are:
Immune-boosting effect of Pegasys provides patients with the chance for a clinical cure
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- Category: Roche
New data presented today showed that, for the first time, doctors can predict which hepatitis B patients treated with Pegasys (peginterferon alfa-2a) have the highest chance to achieve a positive treatment outcome-and even a clinical cure(1,2). The study results represent an important step forward, as some patients will now be able to feel confident during their Pegasys treatment about the likelihood of beating the disease.
New England Journal of Medicine publishes results from the landmark ATHENA trial
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- Category: Sanofi
Sanofi-aventis (Paris Bourse: EURONEXT: SAN; and New York: NYSE: SNY) announced that the ATHENA trial was published in the New England Journal of Medicine. The trial showed that Multaq® (dronedarone), in addition to standard therapy, significantly reduced the risk of first cardiovascular hospitalization or death by 24 percent (31.9% vs. 39.4%, p<0.001) in patients with atrial fibrillation (AF)/atrial flutter (AFL) or a recent history of these conditions.
Sandoz receives European Commission approval for biosimilar filgrastim
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- Category: Novartis
Sandoz has received final approval for its third biosimilar, filgrastim, paving the way for this important oncology medicine to be made available to patients across the European Union. Filgrastim is indicated for the treatment of neutropenia, a condition characterized by a lack of neutrophils - one of the most common types of white blood cells - whose role is to fight infection in the body.
Novartis gains worldwide rights to elinogrel, a Phase II anti-clotting compound
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- Category: Novartis
Novartis has gained the exclusive worldwide rights to elinogrel, a promising anti-clotting agent in Phase II clinical trials that has shown potential to offer clinical improvements over current anti-clotting medications in helping patients avoid heart attacks and strokes.
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