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PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans

... would give approximately 14 mg L-CsA/week. Mean values for C(max) and AUC(0-inf) were up to 20ng/mL and ... leads to highly variable C(max) and AUC(0-12h) values of approximately 1,800ng/mL and 8,000 h ng/mL, ... favorable and significantly lower pharmacokinetic values were obtained for both dose strengths tested. ...

Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant

... and were statistically significant achieving p values of <0.0001 and 0.0001, respectively. In Study ... for both primary efficacy endpoints, achieving p values of 0.0075 and <0.0001 for the Evaluator ... Top-line statistical results showed that p values at Month 6 following third injection were ...

Study Reveals Potential for NT-proBNP as a Marker to Predict Cardiovascular Risks From Anti-Inflammatory Drugs

... results of the pilot study showed that NT-proBNP values greater than 100 ng/L could be linked to an ... those in the corresponding group with NT-proBNP values <100 ng/L.1 For instance, in the coxib group only 9% of patients with NT-proBNP values <100 ng/L showed CV-AEs compared to 41% ...

Newly Published Study Results Showed That Two Mealtime Insulin Dosing Algorithms Were Effective for Patients with Type 2 Diabetes

... 69 percent (Carb Counting) (P=.70); respective values for A1C <6.5 percent were 44.3 percent and 49.5 ... 2, 6, 12, 18, and 24 (endpoint). Blood glucose values at each visit declined in both arms, and the ... than or equal to 6 months and mean +/- SD A1C values of 8.1 +/- 0.9% (Simplified Algorithm) and 8.3 ...

New Research Shows Masimo Perfusion Index (PI) Effective in the Noninvasive Detection of Congenital Heart Defects (CHD) in Newborns

... 1 hour to five days) and established PI reference values of healthy babies. In establishing reference values that validate possible PI indices for normal vs. ... researchers were able to show that low PI values may correspond to illness. Study results showed ...

Three Independent Studies Include the ImmuKnow(R) Assay to Manage and Optimize Immunosuppression Therapy in Transplant Patients

... some viral infections by decreasing immunosuppression when ImmuKnow assay values are <100ng/ml or when post-transplant baseline ImmuKnow values decrease by >50%." Among patients who developed elevated viral levels, ...

Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders

... treatment. No SAEs occurred during 100% HPN-100 treatment. Ammonia values were ~30% lower on HPN-100 assessed as TNAUC over 24 hours [mean (SD) = ... or the percentage of normal values: 58% vs. 72%]. Differences in ammonia values were not statistically significant. "We are very pleased with the ...

NicOx' Naproxcinod Shows Robust Blood Pressure Results in Phase 3 Pooled Analysis

... methods used to make these comparisons (see NOTE 2). The calculation of p values was not planned, although they have been included in this press release ... and assuming heterogeneous (non constant) within study variance. P values for categorized changes from baseline are based on the same mixed model ...

Echo Therapeutics Announces Publication of Positive Clinical Data for its Symphony Transdermal Continuous Glucose Monitoring System in Journal of Diabetes Science and Technology

... data were post-processed for comparison with the reference blood glucose values collected during the study periods. Data were validated for ten subjects ... 98.7%, 100%, and 100% in Study I, II, and III, respectively. Overall MARD values of the three independent studies were between 9.0% and 12.4% -, reflecting ...

Arena Pharmaceuticals Presented Positive Phase 2a Clinical Trial Results of APD125 for the Treatment of Insomnia at 22nd Annual Meeting of the Associated Professional Sleep Societies

... each dosing period. Efficacy was measured objectively by averaging PSG values for N 1/2 and for N 6/7, versus baseline values obtained by averaging results from the screening PSGs. About APD125 ...

New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes

... achieved, CGMS readings for the last 24-hour period were recorded and mean values were compared between treatments using a single-tailed, paired t-test. ... medical costs. Results showed that there was no difference in HbA1c values between Levemir and insulin glargine cohorts, and no significant ...

Medicare Announces Expanded Coverage for Anticoagulation Patients, Opening the Door for More Patients to Test PT/INR at Home

... in Z Kardiol reported that over a two-year period, 80 percent of PT/INR values recorded by mechanical heart valve patients who performed self-testing were in target therapeutic range, compared to only 64.9 percent of PT/INR values monitored by family practitioners.(2) Studies also suggest that PT/INR ...

Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale d'Urologie

... IPSS Quality of Life (QoL), IPSS improvement by > 30% and > 40%, uroflow values (Qmax), PVR and prostate volume at time points up to 28 weeks. Safety ... changes in erectile function (IIEF-5), treatment emergent AEs, lab values (including testosterone, PSA) and vital signs. Mean age was 69.1 (range 52 ...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

... analog currently in development for the treatment of chronic HCV infection. PSI-7851 has demonstrated potent in vitro anti-HCV activity with EC(90) values of 31 +/- 12 nM, which is approximately 15-fold more potent than Pharmasset's first generation nucleoside polymerase inhibitor, RG7128 (formerly ...

Injection Reverses Heart-Attack Damage

... for children, Children ' s Hospital Boston today is a 397-bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families. Children ' s also is the primary ...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

... ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... 100 mg bid 152 101 (66%) 65 (43%) 43 (28%) 41 (27%) p<0.001 p<0.001 p<0.001 <0.001 p values compared to placebo Note: At 6 months. All patients were on stable doses of methotrexate throughout the clinical trial. * The results ...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients

... in LAA doses in either group. FPG levels (-35.5 +/- 3.3 vs. -20.6 +/- 3.2, p=0.0012) and 1-hour PPG (20.9 +/- 4.79 vs. 40.5 +/- 4.56, CI=0.0022) values were significantly lower with AFRESA than with RAA. Patients in the AFRESA group lost weight (-0.5 +/- 0.3), while patients in the RAA group gained ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure

... than or equal to 90 mm Hg). Twenty-four hour ABPM was performed at baseline and end of study (Week 12). One hundred seventy two patients had ABPM values for baseline and end of study. A total of 134 patients (72.4%) were titrated to AML/OM 10/40 mg. About AZOR (R) AZOR is a convenient, once ...

An Independent Study Reports on the Utility of ImmuKnow(R), the Cylex(TM) Immune Cell Function Assay, for Monitoring Heart Transplant Recipients

... investigators at UCLA's David Geffen School of Medicine followed 337 cardiac transplant patients with ImmuKnow to determine whether ImmuKnow assay values can be correlated with the incidence of infection or rejection. The lead investigator, Jon Kobashigawa, MD, favorably remarked, "These results ...

Glycotex' Investigational Compound GLYC-101 Achieves Accelerated Wound Closure Based on Interim Analysis

... Specifically, the efficacy outcomes were statistically significantly different when comparing GLYC-101 0.1% and GLYC-101 1.0% groups to placebo ( p values are 0.0062 and 0.0331, respectively). These interim results suggest that the time to wound closure will be shorter for eyelids treated on the active ...

Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)

... analog currently in developed for the treatment of chronic HCV infection. PSI-7851 has demonstrated in vitro anti-HCV activity with EC(50) values of 90 +/- 60 nM, which is approximately 15- to 20-fold more potent than the active metabolite of Pharmasset's first generation nucleoside polymerase ...

Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in ...

Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

Breast Cancer Clinical Results Show Test Can Differentiate Normal, Early and Later Stage Cancers

... Nipple Aspirate Fluid may distinguish women with or without Breast Cancer" concluded by stating that "GOS reactivity as measured by adjusted chroma values are significantly different between normal patients, those with Ductal Carcenoma In Situ and those with invasive cancer" and that "these results ...

DNA Therapeutics Closes 2.2 Million EUR Series A Financing Round

... SEFTI that is strongly committed to support Life Science innovation at early stage in France and in Europe, and that shares our business vision and values the potential of our drug development based on our unique proprietary siDNA technology. This financing will allow DNA Therapeutics to move ahead with ...

RAD001 Phase II Trial Results Positive in Patients with Advanced Gastric Cancer After Failure of One or More Prior Treatments

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

New Study First to Confirm Sandostatin LAR(R) Depot Controls Tumor Growth in Patients With Rare Gastrointestinal Tumors

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

Verification Studies of IntelligentMDx's Proprietary Molecular Diagnostic Assay Process Have Been Completed

... curves for each plate run (n=14) showed an average slope is -3.37 with a 95 percent confidence interval of (-3.47, -3.27) with all R-squared values are above 0.99 with the exception of one plate. About IntelligentMDx IntelligentMDx's mission is to make FDA approved diagnostic kits. ...

RAD001 Shows Potential to Reverse Resistance to Herceptin(R)* in Metastatic Breast Cancer Patients, Leading to Phase III Trial

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

Video: Femara(R) First Aromatase Inhibitor to Indicate Survival Benefit Versus Tamoxifen When Taken for Five Years After Breast Cancer Surgery

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

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

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

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

... competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred ...

Hologic Releases the Results of the Cervista(TM) HPV Clinical Trials

... the Cervista 16/18 test results were compared to CIN2 and CIN3 clinical end-points. Two potentially important findings were Negative Predictive values for 99.5% for CIN3 and 97.7% for CIN2+. Recent consensus guidelines released by the American Society for Colposcopy and Cervical Pathology (ASCCP) in ...

New Analysis Shows Troubling Trend in Triglyceride Levels May Be Linked to Rising Rates of Obesity

... 74 years who took the blood lipid examination were selected from NHANES II (1976-1980), NHANES III (1988-1994), and NHANES 1999-2006. Adults missing values on total cholesterol, HDL cholesterol or triglycerides were excluded. Where LDL was missing, the Friedewald equation was used to calculate LDL for ...

Study Shows Potential Benefits of Xolair(R) in Treating Children Suffering from Moderate or Severe Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

... protection; competition in general; government, industry and general public pricing pressures the effect that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in ...

FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes

... in the glulisine group and 8.37% (+ or - 1.32) in the lispro group. Postprandial glycemic control, as assessed by the self-monitored blood glucose values and blood glucose excursions, was similar in both treatment groups at endpoint. No noteworthy differences existed between treatment groups in ...

PTC Announces Data Showing That PTC124 Causes Statistically Significant Improvements in Chloride Channel Function in Cystic Fibrosis Patients

... significantly improved CFTR-mediated chloride channel activity as measured by nasal potential difference, with 40 percent of patients achieving values in the normal range during PTC124 administration. The study demonstrated improvements in patients with multiple nonsense mutation types and indicated ...
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(Date:7/31/2014)... available in German . ... gases similar to a sponge that soaks up liquids. ... hydrogen or greenhouse gases. However, loading of many MOFs ... Technology (KIT) now report in Nature Communications ... MOF surface. This can be prevented by water-free synthesis ...
(Date:7/31/2014)... the photovoltaic effect in 1839, humankind has sought to ... its own purposes. In a new research report published ... FASEB Journal , scientists may have uncovered a ... focusing on a naturally occurring combination of lipids that ... over time and across speciessuggests that this specific natural ...
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(Date:8/2/2014)... Dr. Ping Hu is a worldly educated and ... from the Capital Medical University in Beijing, China and ... from the University of London. She completed her ... and finished her fellowship at the University of Illinois ... both inside and outside of the classroom with her ...
(Date:8/2/2014)... When the Black Hat conventioneers descend on Las ... thing can be always counted on, plenty of FUD will ... and doubt. The run-up has already made its share ... Reuters on July 31st about how hackers could use ... successfully infect a system with malware, completely undetected, by leveraging ...
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(Date:8/1/2014)... the University of California, San Diego School of Medicine ... chili peppers produces chronic activation of a receptor ... reaction that ultimately reduces the risk of colorectal tumors. ... 2014 issue of The Journal of Clinical Investigation ... was originally discovered in sensory neurons, where it acts ...
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