Merck Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA®
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- Category: Merck
Merck & Co., Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.
FDA Advisory Committee Finds Data Support SPIRIVA® HandiHaler®
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- Category: Pfizer
The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD).
AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor)
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- Category: AstraZeneca
AstraZeneca today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA.
GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction
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- Category: GlaxoSmithKline
GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals (Nabi) announcedan exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine (NicVAX®), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.
Study Meets Primary Endpoint with 25 Percent LDL Reduction in Very High-Risk Patient Population
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- Category: Genzyme
Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that data from the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were presented at the American Heart Association's Scientific Sessions.
Lower doses of antigen may suffice to generate a protective immune response against A(H1N1)
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- Category: Novartis
Novartis announced new interim data from ongoing clinical trials demonstrating that a single 7.5µg dose of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled immune response criteria associated with protection in adults and the elderly (>=65 years of age).
Abbott Announces Positive Three-Year Data on Its Fully Bioabsorbable Stent Technology
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- Category: Abbott
Abbott (NYSE: ABT) today announced three-year data from the first 30 patients in the first phase of the ABSORB clinical trial, demonstrating that its fully bioabsorbable drug eluting coronary stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries.
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- Abbott to Acquire Novel Investigational Biologic to Treat Chronic Pain
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