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Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

... edoxaban is most closely correlated with minimum concentration levels of the drug in the blood, and that these ... events, rather than total exposure or maximum concentration levels. These findings were presented ... or 60 mg edoxaban given either QD or BID and the concentration of edoxaban in their blood. The analysis examined ...

New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)

... alter the median time it took for maximum plasma concentration of d -amphetamine to be reached in the subjects ... Other pharmacokinetic parameters (maximum plasma concentration and area under curve) of active medication were ... the median time to maximum plasma amphetamine concentration was five hours. The median time to maximum ...

New Keppra XR(TM) Data Highlight Its Role for Patients with Partial-Onset Seizures

... -- The median time to peak plasma concentration was approximately 4 to 5 hours for each dose. ... total amount of drug needed to achieve the same concentration as that found in the blood). -- When the 2 x ... XR dose was taken with food, the time to peak concentration was increased by 2 hours relative to fasted ...

Orexigen(R) Therapeutics Presents Data on Its Proprietary Formulation of Naltrexone Sustained Release (SR) Used in Contrave(R)

... into the bloodstream (Tmax) and reducing the peak concentration it achieves in the blood (Cmax). A series of ... to the IR formulation. The Tmax or time to peak concentration was approximately 36 minutes slower for ... objectives by providing a lower peak plasma concentration (Cmax) than the legacy IR formulation ...

Bioheart Announces 35 Leading U.S. Heart Failure Centers Engaged in Phase II/III Marvel Trial of Myogenic Cells for Treating Advanced Heart Failure

... any unforeseen changes. This study has a cell concentration of up to 200 million cells/ml and administers 16 ... studies involving MyoCell(R) Therapy had a cell concentration of 50 million cells/ml and administered 32 ... survival and engraftment with the higher concentration of cells and lower number of injections, in part ...

Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability

... GD: -- The median time to maximal insulin concentration (Tmax) decreased significantly: 54% for ... 64% for Humulin R (p = 0.0002). -- Insulin concentration increased rapidly and substantially. At 3 ... for Humulin R (p -- The mean maximal insulin concentration (Cmax) was substantially increased: 90% for ...

Ion Mobility Diagnostic Test from Quest Diagnostics is First to Provide Direct Physical Measurement of Lipoprotein Particles, Cardiovascular Disease Indicators, Study Finds

... physical measurement of both the size and concentration of a broad range of lipoproteins in blood plasma. ... contain one apolipoprotein B (ApoB) protein, ApoB concentration may give a better indication of large lipoprotein particle concentration than measurements of cholesterol concentrations ...

Phosphagenics Reports Positive Pre-clinical Results for Targeted Delivery of Lidocaine

... the local area of application. Plasma lidocaine concentration was quantified to evaluate systemic exposure. ... as compared to Xylocaine(R) 5%. The lidocaine concentration in skin was approximately 900% higher 5 hours ... systemic exposure. The average plasma lidocaine concentration peaked 1 hour after the topical application for ...

Pregnant Women Need Omega-3 to Boost Infant Development

... conclusion by first measuring the amount of DHA concentration in the umbilical cord blood of 109 infants. "DHA concentration in the umbilical cord is a good indicator ... and motor development were closely linked to DHA concentration in the umbilical cord blood at the time of their ...

Anacor Pharmaceuticals Announces Positive Results from Phase 2a Clinical Trial of AN2728 in Psoriasis Patients

... trials have investigated the effects of concentration and formulation on drug efficacy. These earlier ... demonstrated significant activity even at a 0.5% concentration of AN2728, the lowest concentration tested. About Psoriasis Affecting ...

Results from Study Evaluating PROCRIT(R) in Intensive Care Unit Patients Published in New England Journal of Medicine

... In these studies, the mean pre-transfusion Hb concentration was 8.5 g/dL. In contrast in this trial, the mean pre- transfusion Hb concentration observed was 8.0 g/dL and the percentage ... will gradually increase the hemoglobin (Hb) concentration to the lowest level sufficient to avoid the ...

Indevus Announces Submission of New Drug Application

... that no patient should exceed a testosterone concentration of 2500 ng/dL, no more than 5% of patients should exceed a concentration of 1800 ng/dL, and no more than 15% of patients ... ng/dL. The duration of time any patient had a concentration over these Cmax thresholds was brief. Of the 102 ...

Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion

... a single 10 milligram dose of alfimeprase with a concentration of 5 milligrams per milliliter in up to 100 ... restore catheter function, however, the dose and concentration we used did not generate results in line with the ... have provided evidence that increasing the concentration can result in marked improvement in thrombolytic ...

R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

... in the lapse of time to determine drug concentrations. However, the drug concentration was below the quantification limit at any of the prescribed time points. ... the total 9 times of application up to the morning of day 5. When the drug concentration in the blood was measured, the level was below the quantification limit as ...

NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia

... orphan drug designation for Qutenza(TM) (formerly NGX-4010), a high concentration capsaicin dermal patch for the management of neuropathic pain in patients ... NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain ...

Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study

... or overt sign of bleeding associated with a decrease in hemoglobin concentration of greater than 50 g/L (or hematocrit greater than 15 percent). TIMI ... for TIMI major bleed, associated with a decrease in hemoglobin concentration of 30g/L to less than or equal to 50 g/L (or hematocrit 9-15 percent). ...

Scientists Discover Why Teeth Form in a Single Row

... outside of the normal row, but also that Osr2 is expressed in increasing concentration in the jaw mesenchyme as you move from the cheek toward the tongue in the mouse embryo, the exact opposite of the BMP4 concentration gradient. Osr2 restricts Bmp4 expression to the tooth mesenchyme under the ...

Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia

... or inducers of CYP3A4 should be avoided as they may affect serum concentration of Tasigna. Concomitant strong CYP3A4 inhibitors The ... also induce CYP2B6, CYP2C8, and CYP2C9. Therefore, Tasigna may alter serum concentration of other drugs. Food effects Food increases blood ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... or inducers of CYP3A4 should be avoided as they may affect serum concentration of Tasigna. Concomitant strong CYP3A4 inhibitors The ... also induce CYP2B6, CYP2C8 and CYP2C9. Therefore, Tasigna may alter serum concentration of other drugs. Food effects Food increases blood levels of ...

Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers

... dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which ... or twice-daily oral dosing of ANA598; (iv) the level of plasma drug concentration of ANA598 predicted to display antiviral potency; (v) the ability of ...

Rubicon Provides Genome Amplification for the Cancer Genome Atlas Project

... technology was judged best to amplify clinical DNA samples to the constant concentration and quality necessary for reproducible and accurate analysis using ... total RNA, and methylated DNA. By producing highly pure DNA of uniform concentration and molecular weight these products increase the sensitivity, specificity, ...

Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company

... products' maximum G-CSF concentrations (Cmaxs) and areas under the G-CSF concentration curves (AUCs) were calculated, and bioequivalence was assessed. Study ... study demonstrated bioequivalence between INS-19 and Neupogen(R). G-CSF concentration profiles for the two products were identical. The Cmaxs following INS-19 ...

Pivotal Pulmonary Arterial Hypertension Study Published in The Lancet Concludes That Bosentan (Tracleer(R)) Demonstrates Benefits in Patients With Mildly Symptomatic WHO Functional Class II Disease

... bosentan on hemodynamics is provided by the reduction of NT-proBNP plasma concentration in the bosentan-treated group compared to the increase in the placebo-treated patients. It is generally considered that a decrease in plasma concentration of NT-proBNP following targeted PAH therapy is a predictive factor for ...

Increases in West Nile Virus Replikin Concentrations Precede Increases in the Number of Human Cases

... BOSTON, May 2 /PRNewswire/ -- Replikins Ltd. has found that the replikin concentration of West Nile Virus increased annually through two distinct cycles as the ... which apparently incubates between seasons, has been found to increase its concentration of Replikins before the next annual step in the cycle of expansion. This ...

Imaging Results From the ADAGIO-LIPIDS Reveal That Effects of Rimonabant on Cardiometabolic Risk Profile Include Loss of Visceral Fat and Mobilization of Liver Fat

... (decrease of 6.5% vs placebo, p<0.0001) and a concomitant increase in the concentration of large LDL particles (increase of 4.8% vs placebo). Several markers of ... (p<0.01) whereas there was a very significant increase in the blood concentration of an important adipose tissue-derived cytokine, adiponectin, which ...

Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy

... MLD is caused by a deficiency in the enzyme ASA which causes an excess concentration of sulphatide in cells and an ensuing breakdown of myelin. There are ... the lysosomal enzyme arylsulfatase A (ASA) which results in an increased concentration of sulphatide in cells of the brains and in non-neural tissue, such as the ...

Study Results of GAMMAGARD S/D and GAMMAGARD LIQUID in Patients with Mild-to-Moderate Alzheimer's Disease Announced

... in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these ... in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these ...

Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference

... reactions characterized by erythema, induration, and ulceration in a concentration dependent manner. -- In rodent intradermal models, the maximal concentration of bisphosphonates that could be administered without producing ISRs ...

Additive Anti-Tumor Activity of NKTR-102 in Combination With Bevacizumab Highlighted in Positive Preclinical Data Presented at AACR Meeting

... with a 6-fold increase in exposure (AUC) and a 4-fold lower peak plasma concentration (Cmax) of SN38, the active metabolite of irinotecan, as compared to the equivalent dosing of irinotecan. The lower peak plasma concentration of NKTR-102 was associated with a superior tolerability profile, with less ...

Nuvelo Announces Phase 2 SONOMA-3 Trial Did Not Meet Target Product Profile and Discontinues Alfimeprase Development

... over the previous Phase 3 SONOMA-2 trial, which evaluated a lower dose and concentration of alfimeprase than the SONOMA-3 trial, the clearance rate at one hour ... or dose response expected with the significantly increased dose and concentration we tested in the SONOMA-3 trial," said Dr. Ted W. Love, chairman and chief ...

Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously

... at an adapted dose, as measured by the area under the curve of IgG concentration vs. time curve per week. Final results of the study are expected to become ... in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these ...

Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)

... levels, including thresholds that no patient should exceed a testosterone concentration of 2500 ng/dL, no more than 5% of patients should exceed a concentration of 1800 ng/dL, and no more than 15% of patients should exceed a ...

Spectrum Pharmaceuticals Announces Presentation of SPI-1620 Data at the AACR-NCI-EORTC International Conference

... received paclitaxel 15 minutes after SPI-1620 was administered. Paclitaxel concentration was determined in the tumor, and in a number of normal tissues. Mice ... saline treated mice. SPI-1620 treated mice also had over 5 fold increased concentration of paclitaxel in tumors, and no significant change in normal tissues ...

Study Shows Vasopressin Receptor Antagonist VAPRISOL(R) (Conivaptan Hydrochloride Injection) Significantly Increased Serum Sodium Concentration in Patients with Euvolemic & Hypervolemic Hyponatremia

... respectively (p<.001). At study's end, the mean change in serum sodium concentration was 6.3 mEq/L in patients who received VAPRISOL 40 mg/day and 9.4 mEq/L in ... (p /= 6 mEq/L increase in serum sodium levels or a normal serum sodium concentration (>/= 135 mEq/L) over the treatment period, compared with 20.7 percent of ...

Baxter and The Alzheimer's Disease Cooperative Study Group to Pursue a Phase III Study of Gammagard Liquid in Patients With Alzheimer's Disease

... in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these ... in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these ...

Tiny Cup Attached to Eye Improves Drug Delivery For Retinal Diseases

... one in 15,000 children, must now be given intravenously. This requires relatively large doses of the drug are needed to achieve a therapeutic concentration in the retina. The chemotherapy destroys the bone marrow and depresses the child's immune system, often leading to secondary infections. ...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... endpoint was reached with patients benefiting from a clinically important and statistically significant (p<0.0001) increase in mean hemoglobin concentration compared with baseline after receiving velaglucerase alfa at 60 U/kg IV every other week for 12 months. Statistically significant improvements ...

VisEn Molecular Imaging Technology Enables Key Insights Into Newly Discovered Biologic Pathway Published in SCIENCE

... Deployment to Inflammatory Sites ," researchers at the Massachusetts General Hospital's Center for Systems Biology found that monocytes were held in concentration in the spleen and released to injured tissue sites in the body to participate in wound healing. As presented in the findings, the reporting ...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

... August 16, 2009. NeurogesX' second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 has completed three Phase 1 studies and NeurogesX is ...

Neuroscience Researcher Has Positive Message for International Alzheimer's Awareness Week, July 6 - 12: 'Even Though World Economy is Declining, Alzheimer's Research is Advancing'

... can be developed incorporating the jellyfish calcium-binding protein. "We have shown that normal adults can improve their memory, focus, and concentration by lowering their neuronal calcium," says Underwood. "We are very optimistic that the same compound can now be tested on Alzheimer's patients to ...
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(Date:9/30/2014)... engineers, led by Clemson University associate professor Brian ... from the U.S. Department of Energy,s Experimental Program ... positive impact on South Carolina in the advancement ... , "Understanding the scientific and engineering needs for ... nuclear technologies is imperative if South Carolina is ...
(Date:9/30/2014)... and farm runoff in Hawaii is causing tumors in ... The study, published Tuesday in the peer-reviewed open-access journal ... ends up in algae that the turtles eat, promoting ... and internal organs. , Scientists at Duke University, the ... Administration (NOAA) conducted the study to better understand the ...
(Date:9/30/2014)... available in German . ... response to risky situations such as exposure to predators. ... found in a long-term study on different populations of ... rate and ambient temperature. High metabolic rates and low ... these scenarios birds were more likely to approach potential ...
Breaking Biology News(10 mins):Researchers get $5.25 million to advance nuclear technologies in South Carolina 2Pollution linked to lethal sea turtle tumors 2Pollution linked to lethal sea turtle tumors 3Risky metabolism 2
(Date:10/2/2014)... 2014 Robins & Morton received ... Builders and Contractors (ABC) of Alabama. , ABC ... held at Sheraton Birmingham Hotel., , ... Million to $25 Million, Obelisk Award (First Place) ... Government $10 Million to $25 Million, Obelisk Award ...
(Date:10/2/2014)... Australia (PRWEB) October 02, 2014 ... markets, organic food is becoming increasingly popular with ... Organic Livestock and Poultry Farming industry in ... “the popularity of organic meat has surged over ... and expansion at the farming level.” Over the ...
(Date:10/2/2014)... HealthDay Reporter WEDNESDAY, Oct. 1, 2014 (HealthDay ... long-acting implanted devices -- could slash pregnancy and abortion rates ... In a study of 1,400 teenage girls, researchers found ... of unplanned pregnancy and abortion. Over three years, their annual ... rate of 158 per 1,000 among all sexually active teenage ...
(Date:10/2/2014)... have pinpointed a molecule that may trigger potentially life-threatening ... say this finding could offer a target for new ... Most asthma attacks (80 percent to 90 percent) are ... the British researchers. Most of these are rhinoviruses, which ... The researchers found that a specific molecule called IL-25 ...
(Date:10/2/2014)... WEDNESDAY, Oct. 1, 2014 (HealthDay News) -- Children with ... but they,re fully capable of being more active, a ... activity levels of 29 children, some with autism and ... per day of moderate physical activity and 70 more ... The 17 children with autism scored lower on strength, ...
Breaking Medicine News(10 mins):Health News:Robins & Morton wins nine awards from Associated Builders and Contractors 2Health News:Organic Livestock and Poultry Farming in Australia Industry Market Research Report Now Available from IBISWorld 2Health News:Organic Livestock and Poultry Farming in Australia Industry Market Research Report Now Available from IBISWorld 3Health News:Organic Livestock and Poultry Farming in Australia Industry Market Research Report Now Available from IBISWorld 4Health News:Free, Long-Acting Contraceptives May Greatly Reduce Teen Pregnancy Rate 2Health News:Free, Long-Acting Contraceptives May Greatly Reduce Teen Pregnancy Rate 3Health News:Free, Long-Acting Contraceptives May Greatly Reduce Teen Pregnancy Rate 4Health News:New Clues to How Colds Can Spur Asthma Attacks 2Health News:Kids With Autism Tend to Be Less Active, Study Says 2
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