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Articles > FDA

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Transdel Pharmaceuticals presents Ketotransdel Phase 3 data at 13th World Pain Congress
Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, announced today the final data set from its Phase 3 study of KetotransdelĀ® (TDLP-110) at the 13th World Congress on Pain in Montreal, Canada.

ThromboGenics second microplasmin Phase III trial for non-surgical treatment of VMA meets primary endpoint
ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer announces that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint.

Estradiol prevents vascular permeability following hemorrhagic shock: Study
A study published in the September 2010 issue of SHOCK by Dr. Ed W. Childs and colleagues at Scott & White Healthcare looks at how female versus male rats fared after suffering a trauma and subsequent hemorrhagic shock who were given Estradiol (estrogen). In the study, the Estradiol

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer
Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to

Sangart reports positive MP4OX Phase IIa study data in severely injured trauma patients with hemorrhagic shock
Sangart, Inc., today announced positive results from its Phase IIa proof-of-concept study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. The study demonstrated that MP4OX, when given in addition to standard of care, was effective at decreasing lactate levels in

Sangart reports positive data from MP4OX Phase IIa study in trauma patients
Sangart, Inc., today announced positive results from its Phase IIa proof-of-concept study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. The study demonstrated that MP4OX, when given in addition to standard of care, was effective at decreasing lactate levels in

Standard dose of UFH optimal for treatment of PCI patients on fondaparinux: Study
A landmark international study, coordinated by McMaster University, has found that lower doses of a blood thinner called unfractionated heparin (UFH) during angioplasty did not reduce bleeding or vascular complications compared to standard dose UFH in patients initially treated with a blood thinner, fondaparinux.

Phase 3 AVERROES trial reveals apixaban effective for atrial fibrillation patients unsuitable for warfarin
The phase 3 AVERROES (Apixaban Versus Acetylsalicylic acid (ASA) to Prevent Strokes) trial, designed to show the superiority of apixaban over aspirin for the prevention of stroke or systemic embolism in high-risk atrial fibrillation patients unsuitable for treatment with a vitamin K antagonist (warfarin), was terminated early following

ANTIPAF trial reveals ARBs do not reduce number of AF episodes in paroxysmal AF patients
Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting about 7 million people in Europe. It is a progressive chronic disease in which episodes become more frequent and long-lasting over time. Conventional anti-arrhythmic therapy aims at halting progression and reducing symptoms, but the use of most anti-arrhythmic

Unfractionated heparin standard dose may be optimal treatment strategy in PCI patients on fondaparinux
Results from the FUTURA/OASIS 8 study presented today at the ESC Congress provide initial evidence that a low dose of unfractionated heparin does not reduce the incidence of bleeding or vascular complications in PCI patients treated with the anticoagulant fondaparinux. Findings showed that the rates of peri-PCI major


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