Pfizer And Medicines For Malaria Venture Seek To Expand Fight Against Malaria With Intermittent Preventive Treatment Option For Pregnant Women
NEW YORK & GENEVA – Pfizer Inc. and Medicines for Malaria Venture (MMV) entered into an agreement for the development, access and delivery of a fixed-dose combination treatment consisting of azithromycin dihydrate (AZ) and chloroquine phosphate (CQ) for the Intermittent Preventive Treatment of P. falciparum malaria in pregnancy (IPTp). There is currently an unmet need [...]
Pfizer Discontinues Phase 3 Trial of Sutent® in Advanced Hepatocellular Carcinoma
NEW YORK - Pfizer Inc. announced today the discontinuation of the SUN 1170 Phase 3 open-label study of Sutent(r) (sunitinib malate) in advanced hepatocellular carcinoma (HCC), or liver cancer. Following a review by the independent Data Monitoring Committee (DMC), the study was discontinued based on a higher incidence of serious adverse events in the sunitinib arm [...]
Novartis receives approval in the European Union for Menveo®, first quadrivalent conjugate vaccine in the EU to help prevent meningococcal disease
Basel, March 18, 2010 – Novartis announced today that the European Commission (EC) granted a Marketing Authorization for Menveo® (Meningococcal Group A, C, W135 and Y conjugate vaccine) in all 27 European member states. Menveo is indicated for the active immunization of adolescents (from 11 years of age) and adults at risk of exposure to [...]
CPEX Pharmaceuticals Announces Preliminary Results from its Phase 2a Clinical Trial of Nasulin™
EXETER, N.H.–(BUSINESS WIRE)–CPEX Pharmaceuticals Inc. (NASDAQ: CPEX) today reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the Company’s nasal insulin product, Nasulin™. The study was designed to evaluate the efficacy and safety of Nasulin versus placebo over a 6-week treatment period in subjects with Type 2 diabetes who were being treated with [...]
U.S. Food And Drug Administration Accepts New Drug Application For Once-Daily Fixed Dose Combination Of Onglyza™ (Saxagliptin) And Extended Release Metformin For The Treatment Of Type 2 Diabetes Mellitus In Adults
PRINCETON, N.J. & WILMINGTON, Del. – Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a [...]
Study Shows Prevenar 13* Is Immunogenic In Young Children Previously Vaccinated With Prevenar*
NEW YORK – According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). These data were [...]
Exploratory trial shows no incremental benefit of aliskiren add-on therapy in improving changes to cardiac shape in heart attack patients
Basel, March 16, 2010 – The addition of the cardiovascular medicine aliskiren to standard therapy for patients recovering from a heart attack showed some positive effects in helping limit changes in the heart’s shape and function, but did not demonstrate a statistically significant benefit, according to new clinical trial results[1].
Data from the ASPIRE study (Aliskiren [...]
Intensive Lipitor Therapy Was Associated With Reduced Risk Of Cardiovascular Events In Two High-Risk Patient Groups
ATLANTA – Lipitor® (atorvastatin calcium) 80 mg was associated with a significantly reduced risk of major cardiovascular events compared with Lipitor 10 mg among patients with both coronary heart disease (CHD) and chronic kidney disease (CKD) who were obese or had metabolic syndrome. These data, from two sub-analyses of the Treating to New Targets (TNT) [...]
New Analysis Assesses Impact of Common Genetic Variation on Benefit of Antiplatelet Therapy
PARSIPPANY, N.J. and INDIANAPOLIS, March 15, 2010 - A new analysis of the TRITON-TIMI 38 study evaluated response rates in patients with a common genetic variant in the ABCB1 gene. Patients enrolled in the TRITON-TIMI 38 study were treated with dual antiplatelet therapy with either Plavix(R) (clopidogrel) plus aspirin or Effient(R) (prasugrel) plus aspirin and managed [...]
New Data From Second Phase Shows No Blood Clots, No Repeat Procedures and Very Low MACE in Patients Treated with Abbott’s Innovative Device
ATLANTA, March 15, 2010 - Abbott (NYSE: ABT) today announced positive 30-day results from the first 101 patients enrolled in the second phase of the ABSORB trial. Patients treated with Abbott’s bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of blood clots (thrombosis), no need for repeat procedures (ischemia-driven target lesion revascularization) [...]
