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Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... cancer) or multiple myeloma. For the primary endpoint, patients treated with denosumab ... caused by the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone ... of denosumab versus Zometa. The primary endpoint was to evaluate if denosumab is ...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... SUSTENNA(TM) for a period of 13 weeks. The primary endpoint of this study was the change in total ... involving INVEGA(R) SUSTENNA(TM) met its primary endpoint of significantly improving PANSS scores ... study (n=410). Time-to-first relapse -- the primary endpoint of the study -- was significantly longer ...

S.C. Medical Home Pilot for Diabetes Enrolls 1,110

... Health Plan and who are patients of Palmetto primary Care Physicians in the Charleston, S.C., area. ... management and patient educational services into primary care practices. The concept places the primary care doctor in charge of a team that can include ...

New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FTC Revealed

... emtricitabine (Truvada(R)). The study's primary endpoint was virologic response at 48 weeks of ... or change of therapy prior to week 48. In the primary analysis of the primary endpoint, the two nevirapine arms were combined. ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two pivotal ... comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level ... (ITT) analysis, belimumab met its primary efficacy endpoint of superiority versus placebo ...

University of Michigan Study Shows SEQUENOM's MassARRAY Technology Identifies HPV Infections Missed by Standard Hybridization Test

... than 60 years, the well known "Pap smear" was the primary method for detecting early signs of cervical ... DNA will one day supplant the Pap smear as the primary screening test for cervical cancer. Yet, ... DNA will one day supplant the Pap smear as the primary screening test for cervical cancer, the Company's ...

Results From Trials of DHA in Alzheimer's Disease and Age-Related Cognitive Decline

... by Martek Biosciences Corporation (Martek), the primary company that makes algal DHA for supplementation. ... received DHA had a slower rate of decline on the primary test of mental function (the ADAS-cog). A trend ... (average age=70) with mild memory complaint. The primary outcome measure was a change from baseline in ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior ... caused by the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone ... of denosumab versus Zometa. The primary endpoint was to evaluate if denosumab is ...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

... in major abdominal surgery patients achieved primary and secondary endpoints REDWOOD CITY, ... allowed to drop out of the study at any time. The primary efficacy endpoint was SPID-12 (a cumulative ... Phase 2 study is currently ongoing with the primary objective of assessing the functionality of the ...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

... - FDA Agreement Reached on Phase 3 Study Design, primary Endpoint and Histological Methodology - ... pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney ... will be 150 mg every other day. The primary endpoint will be the change in the amount of ...

Study Demonstrates Efficacy of Pitavastatin in Elderly Patients

... cholesterol in a group of elderly patients with primary hypercholesterolemia or combined dyslipidemia," ... patients aged more than or equal to 65 years with primary hypercholesterolemia or combined dyslipidemia. ... a suitable statin for elderly patients with primary hypercholesterolemia or combined dyslipidemia who ...

Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis

... or 100 mg) every four weeks for two years. The primary endpoint was ACR 20 response at week 14 for ... 50 mg to 100 mg based on clinical judgment. The primary endpoint was ACR 20 response at week 14 for ... 50 mg or 100 mg or placebo every four weeks. The primary endpoint was the proportion of patients achieving ...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

... states. In so doing, the EMEA agreed to the primary endpoint and the other principal design features ... seek to enroll an estimated 166 patients. The primary endpoint is the treatment failure rate at Study ... orBec(R)'s chances for success. With our primary endpoint of the 'treatment failure rate at Study ...

Micromet's Blinatumomab Achieves Primary Endpoint in Phase 2 Study with Acute Lymphoblastic Leukemia Patients

... prognosis than patients without MRD. The primary endpoint of the phase 2 study is MRD response ... the limit of detection. The achievement of the primary endpoint requires that at least 22% of 21 ... thus qualifying the trial as having met its primary endpoint before the completion of the study. ...

Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting

... on the Disability Assessment Scale [DAS] for the primary therapeutic target after injection of a 20 U/mL ... Hygiene (9.4%) and Pain (6.3%) were chosen as primary therapeutic target on the DAS. The maximum ... DAS reduction from the baseline score for their primary therapeutic target. No dilution group was ...

Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

... significant improvement versus placebo in both primary and secondary efficacy assessments at all study ... phase 3 placebo-controlled trial." The primary efficacy measure was the BPRSd (Brief Psychiatric ... could be discharged or remain hospitalized. The primary efficacy measure was the BPRSd extracted from the ...

Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain

... and Safety Study, or REDUCE-1 and REDUCE-2. The primary objective of these studies was to evaluate the ... at baseline and weeks 8, 16 and 24. The primary efficacy objective of REDUCE-1 was to evaluate ... patients at risk for NSAID-induced ulcers. The primary objective of REDUCE-2 was to evaluate HZT-501 in ...

Data From Clinical Study of bioTheranostics Molecular Diagnostic Test Presented at American Society of Clinical Oncology Annual Meeting

... origin with 75 percent accuracy in patients whose primary cancer was 'unknown' using traditional ... origin with 75 percent accuracy in patients whose primary cancer was initially "unknown" using traditional ... alone) receive a diagnosis of cancer of unknown primary origin, or CUP, meaning their cancer has spread ...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

... Program Evaluating XERECEPT(R) in Patients with primary and Metastatic Brain Tumors Administration ... patients with cerebral edema associated with both primary and metastatic brain tumors. The Company also ... of patients with edema associated with either primary or metastatic brain tumors. ...

Video: Phase III Study Data With Vandetanib (Zactima(TM)) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Presented at American Society of Clinical Oncology

... in Orlando. Results show that the study met its primary endpoint, demonstrating that the addition of ... program, are supportive of ZODIAC although the primary endpoint did not reach statistical significance ... also presented at this year's ASCO. While the primary objective of demonstrating a statistically ...

Mayo Researchers Help Discover Genetic Cause for Primary Biliary Cirrhosis

... path that predisposes patients to develop primary biliary cirrhosis , a disease that mainly affects women and slowly destroys their livers. primary biliary cirrhosis has no known cause. The ... that we better understand the molecular basis of primary biliary cirrhosis, we can look for ways to ...

New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal

... time periods (P <0.001), achieving both the primary efficacy endpoint of the sum of pain intensity ... over a 72-hour period following surgery. The primary efficacy endpoint was the sum of pain intensity ... events. Respiratory depression is the primary risk of mu-opioid agonists. Respiratory ...

Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients

... International Phase III ACTEMRA Study Meets its primary Endpoints - NUTLEY, N.J., May 25 ... development program to successfully meet its primary endpoints in patients with moderately to severely ... are completed and have reported meeting their primary endpoints. ACTEMRA is currently under review by ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... efficacy and safety of pirfenidone. The primary endpoint of change in percent predicted Forced ... were also met with statistical significance. The primary endpoint was not met in CAPACITY 1 (p=0.501), but ... observed on a number of measures, including the primary endpoint. Pirfenidone was safe and generally ...

Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection

... announced in November 2008. The trial met its primary endpoint with fidaxomicin achieving clinical cure ... USP) for the treatment of CDI. The primary endpoint of the study was clinical cure defined ... cessation of antibiotic administration. primary risk factors for CDI include broad-spectrum ...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

... (RA) receiving methotrexate successfully met its primary endpoint. The top-line results from the recently ... in RA signs and symptoms at 12 weeks, the primary endpoint of the study, as measured by the ... every two weeks for a total of six doses. The primary endpoint of the study was ACR20 response at 12 ...

BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financial Results

... the study demonstrated a numerical trend in its primary endpoint of improvement in the median time to ... whose symptom duration was 36 hours or less. The primary analysis population consisted of patients with ... which was also sponsored by Shionogi, met its primary endpoint of time to alleviation of symptoms for ...

Three Clinical Presentations on Tapentadol Extended Release Tablets for Chronic Pain Featured at 2009 American Pain Society Annual Meeting

... Placebo- and Active-controlled Phase 3 Study ; primary investigator: Robert Buynak, M.D. Poster ... Study of Patients With Chronic Low Back Pain ; primary investigator: Robert Buynak, M.D. Friday, ... Pain: Analysis of Efficacy Endpoint Sensitivity ; primary investigator: Mila Etropolski, M.D. ...

Boston Scientific Welcomes Publication of HORIZONS AMI Trial Results in New England Journal of Medicine

... reduced angiographic restenosis and the primary efficacy endpoint of ischemia-driven target ... bare-metal Express(R) Stent control. The primary safety measure showed no difference between the ... mm vs. 0.82 +/- 0.70 mm, p<0.001). The primary safety endpoint of MACE at one year was ...

Anthera's Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome

... an Acute Coronary Syndrome (ACS) event, met its primary endpoint of a reduction in Low Density ... adverse lipid profiles. The pre-specified primary endpoint analysis was conducted when 500 patients ... after an ACS event. In addition to meeting the primary endpoint, additional efficacy analyses at a ...

Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple Sclerosis

... - primary Endpoint met With a Significant Reduction in ... of Neurology (AAN) in Seattle, WA. "All primary and secondary endpoints of the CLARITY study were ... were administered to all patient groups. The primary endpoint of the CLARITY study was the qualifying ...

New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting

... the study were switched successfully, meeting the primary endpoint. About the Studies A ... The UPDRS II+ III score was used as the primary efficacy endpoint in both trials. UPDRS Part II ... immediate release formulation (2:1 ratio). primary efficacy endpoint was the proportion of patients ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... direct enrollers into the maintenance study. The primary efficacy measure for the study was time to ... requiring additional therapy. In the primary efficacy analysis, 36 patients in the control arm ... nor was there a pattern to them. In the primary analysis, PEGINTRON maintenance therapy was not ...

Human Genome Sciences Reports Positive Late-Breaker Results at EASL from ACHIEVE Phase 3 Trials of Albuferon(R) in Patients with Chronic Hepatitis C

... trials, Albuferon (albinterferon alfa-2b) met the primary efficacy endpoint of sustained virologic response ... that Albuferon(R) (albinterferon alfa-2b) met its primary endpoint of non-inferiority to peginterferon ... demonstrate that albinterferon alfa-2b met its primary efficacy endpoint of non-inferiority to ...

QRxPharma Successfully Completes Comparative Study for Dual-Opioid(TM) Pain Therapy

... primary Endpoints Met; Data Demonstrate MoxDuo(TM) IR ... oxycodone every 6 hours for 48 hours. The study's primary clinical endpoint was changes in the pain ... successfully completed a Phase 3 study and met primary and secondary endpoints. The Company's ...

Prometheus and Rosetta Genomics Announce License and Collaboration Agreement

... mets is designed to accurately identify the primary tumor site in patients presenting with metastatic ... consequently has been labeled Cancer of Unknown primary (CUP). As metastases need to be treated according to their primary origin, accurate identification of ...

Schering-Plough Announces Results of the Early ACS Trial

... to angiography, failed to achieve either the primary or secondary endpoints of the trial. ... with ACS compared to delayed provisional use. The primary efficacy endpoint was a composite of death, ... was observed between the groups in either the primary or secondary endpoints. ...

CRESTOR(R) Reduced CV Risk in Patients Achieving Low LDL and hsCRP Targets in New JUPITER Analysis

... ABOUT JUPITER: Results from the primary analysis of JUPITER (Justification for the Use of statins in primary prevention: an Intervention Trial ... and to increase HDL-C in adult patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is ...

Impulse Dynamics Announces Pivotal Results at the American College of Cardiology Annual Meeting Late-Breaking Session

... randomized study to date. The study met its primary safety endpoint, which was a noninferiority ... the results did not meet the study's overall primary efficacy endpoint demonstrating improvement in ... and quality of life (p=0.003), but also in the primary endpoint of ventilatory anaerobic threshold ...

MultiCell Technologies Signs Liver Stem Cell R&D Agreement To Develop Products for the Study of Liver Cancer

... by maturation arrest of liver stem cells. primary liver cancer begins in the cells of the liver ... 2008 there were approximately 21,400 new cases of primary liver cancer and intrahepatic bile duct cancer in ... of the liver in 50% to 80% of patients. primary liver cancer is rarely discovered early, and ...
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