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Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain

... 12 value, p=0.068). Two of the exploratory scales (daily NRS and non-menstrual pelvic pain, each ... The results from both of these two exploratory scales are in direct contrast to the statistically ... placebo on a composite of the FDA-suggested daily scales (total score DYS + NMPP): elagolix 150 mg, ...

Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

... Disease Rating Scale (UPDRS) is one of the most widely used rating scales used to follow the course of Parkinson's disease. It is made up of 44 ... The Clinical Global Impression (CGI) is the general name for two rating scales that are commonly used in clinical trials. The CGI-C scale measures the ...

Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients

... shown with the instrument for global health status (P < 0.001), on all 5 scales for patient functioning (P < 0.001), on all 3 symptom scales (P less than or equal to 0.002), and on 4 of 6 single-item measures (P < ....

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

... receptor-positive early breast cancer taking adjuvant Femara had better overall cognitive function than those taking tamoxifen, based on validated scales of cognitive function collected at the fifth year of endocrine treatment(6). Results from this study revealed that the group of patients ...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

... analyzed using a mixed model for repeated measures. Multiple safety assessments were done, including vital signs, weight, ECGs, movement disorder scales (SAS, BAS, AIMS), and laboratory assessments. The study was conducted at 51 sites worldwide. Twenty-two sites in the United States randomized ...

Synvista Therapeutics Announces First Dosing of SYI-2074 in Clinical Trial for Psoriasis

... About Psoriasis Psoriasis is an immune-mediated chronic inflammatory disease usually characterized by red lesions or silvery white scales on the skin, which usually occur on the scalp, knees, elbows, the abdomen (around the navel) and the genitals. In about a quarter of the cases, ...

Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientific Meeting

... acetate prevented immunologic changes induced by gluten in patients with celiac disease. In addition, studies to establish the validity of scales such as GSRS are an important step forward in the development of effective treatments for celiac disease." "Alba is excited to be advancing the ...

invivodata Captures Symptom Relief Data in Endometriosis Trial

... twice daily to record the frequency and severity of endometriosis symptoms before, during, and after six months of treatment, using several different scales to measure dysmenorrhea and pelvic pain. Data captured on DiaryPRO helped Neurocrine demonstrate a clinically meaningful and ...

Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis

... of endometriosis symptoms following treatment with elagolix. Improvement in endometriosis symptoms was documented using several different scales for endometriosis pain. The following were assessed before, during and after the six months of treatment: -- Total Composite Pelvic Sign and ...

Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates

... two hours after the first dose. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded ...

Controversy About Lack of Placebo Group Decline in Alzheimer's Clinical Trials

... less worsening over the time period of current studies. It has been speculated that this may be due to: -- Inadequate sensitivity of the standard scales used for measuring cognition in these trials. -- Differences in disease severity and co-existing medical conditions between the populations being ...

Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)

... at 2 hours after the first dose. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded ...

Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation

... The trial protocol specified that various assessments of a patient's agitation state be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects were recorded throughout ...

Neurocrine Biosciences Reports First Quarter 2008 Results

... safety, tolerability and pharmacokinetics will be conducted. The clinical endpoints reflect change in symptom frequency and severity via validated scales for IBS and the data should be available in the second half of 2008. GSK is also advancing the second lead CRF1 receptor antagonist, 561679, into a ...

Breakthrough Large Scale Transfection Technology Accelerates Cell-Based Assay Development

... rapid and efficient transfection of any kind of cell or cell line with any molecule (plasmids, proteins, protein complexes, drugs, mRNA, siRNA), at scales ranging from micro-liters to liter volumes. MaxCyte's ITF Inline Transfection System enables transient transfection of cell lines as well as ...

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

... of the skin caused by a reaction of the immune system. It is characterized by thickened patches of inflamed, red skin covered with thick, silvery scales typically found at the elbows, knees, scalp and genital areas. About Anacor Pharmaceuticals Anacor is a biopharmaceutical company developing ...

Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status

... Scale) Excited Component Score. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded ...

Neurocrine Biosciences Reports Fourth Quarter and Year-End 2007 Results

... of safety, tolerability and pharmacokinetics will be conducted. The clinical endpoints reflect change in symptom frequency and severity via validated scales for IBS and the data should be available in the second half of 2008. GSK is advancing the second lead CRF1 receptor antagonist, 561679, into a ...

Novel Mechanism for Long-Term Learning Identified by Carnegie Mellon Researchers

... -- Practice makes perfect -- or at least that's what we're told as we struggle through endless rounds of multiplication tables, goal kicks and piano scales -- and it seems, based on the personal experience of many, to be true. That's why neuroscientists have been perplexed by data showing that at the ...

Statement of Andrea Kavanagh, Director, Pure Salmon Campaign, on the Science Sea Lice Study

... the same waters. Sea lice concentrated around the fish farms latch on to wild salmon as they swim past the open net pens. Adult salmon have thick scales to fight off these parasites, but juveniles lack the defenses to keep them healthy and safe. Sea lice chew on young salmon, creating open lesions ...

Long-Term Soliris(R) Therapy Improved or Stabilized Kidney Function in Patients With PNH

... (P meaningful in this instrument. A similar improvement in fatigue was demonstrated with the EORTC instrument (P from both fatigue scales showed more improvement in the latter time period. -- Other quality of life parameters also significantly improved both during the first and ...

SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia

... (16 items) subscale scores were summarized to give the PANSS total score.(8) ** The Clinical Global Impression (CGI) consists of 3 global scales or items (Severity of Illness; Global Improvement; Efficacy Index). For the primary endpoint of Study 004, item 2, the Global Improvement ...

Post-Hoc Data Show Daily Activity Participation, Independence and Sleep Quality Improved in Adults with Moderate to Severe Rheumatoid Arthritis After Treatment with ORENCIA(R) (Abatacept)

... group (p-value less than 0.0001) and Index II was -9.8 in the ORENCIA group and -2.1 in the placebo group (p-value less than 0.0001). MOS-sleep scales measuring awakened short of breath or with headache and snoring were not significantly different in the ATTAIN group. In the AIM study, measurement ...

New Data Show Improvements in Work Performance in Patients with Chronic Insomnia Treated with AMBIEN CR(R) (zolpidem tartrate extended-release) Tablets CIV

... all of the time). WLQ outcomes were assessed at baseline, week 4, 12, and end of treatment (week 24) or premature discontinuation. Two of the WLQ scales were included in the study: worker output and time management. Worker output assessed the ability to meet demands for quantity and quality of work ...

Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Legs Syndrome

... for a dopamine agonist in RLS to date. In these studies, the efficacy of rotigotine was evaluated by monitoring several clinician-administered scales including the IRLS, the Clinical Global Impressions (CGI) and the Restless Leg Syndrome-6 (RLS-6). The IRLS scale measures the severity and frequency ...

DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947

... a 100 mg daily dose of DOV 216,303, the parent compound of DOV 21,947, produced a statistically significant reduction in Hamilton Depression Rating scales in a Phase II clinical trial in patients with major depressive disorder. In animal models highly predictive of antidepressant action, DOV 21,947 was ...

Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate

... the paper number is 235. Lexicon will also present a separate poster titled, "Open access mass-directed purification: Adaptation to diverse loading scales and compound polarities," at the same conference on August 19, 2007. The paper number is 174 and will be included in the Division of Medicinal ...

Data Suggest Cymbalta Improved Functioning in Patients with Generalized Anxiety Disorder

... effect of Cymbalta, which was not measured on any of the three scales used in the study. -- In improvement in work functioning, 36 percent ... global functioning through the treatment of additional symptoms that the scales in our clinical trials do not measure. These symptoms could be related to ...

New Data Suggests Less Abuse-Related Effects For OROS Methylphenidate

... Pharmacodynamics of potential abuse were assessed with Visual Analog scales (VASs). The magnitude of scores on the VAS scales was ranked (lowest to highest) as placebo < OROS(R) methylphenidate (MPH) ...

New Data Focuses on Abuse of Stimulant Medication

... Pharmacodynamics of potential abuse were assessed with Visual Analog scales (VASs). The magnitude of scores on the VAS scales was ranked (lowest to highest) as placebo< OROS(r) methylphenidate (MPH) ...

Phase III Data on Safinamide in Parkinson’s Disease Presented at American Academy of Neurology 59th Annual Meeting

... disorders and restless leg syndrome, as per the agreement signed with Newron in October 2006. 1 The UPDRS is one of the most widely used rating scales used to follow the course of Parkinson’s disease. It is made up of 42 items, scored from 0 to 4, to establish individual patients’ ...

Data Suggest Cymbalta Reduced Severity of Night Pain in Patients with Diabetic Nerve Pain

... of somnolence, were collected by spontaneous report, and while spontaneous reporting is the standard practice for evaluating treatments, solicited scales specifically designed for particular adverse events would have been preferable for the investigation. About Diabetic Peripheral Neuropathy ...

New England Journal of Medicine Publishes New Data on Gardasil, Merck's Cervical Cancer Vaccine

... were used to assess immunogenicity to each vaccine HPV type. These assays measured antibodies against neutralizing epitopes for each HPV type. The scales for these assays are unique to each HPV type; thus, comparisons across types and to other assays are not appropriate. Immune Response to ...

Data Published in The Lancet Show Gardasil was 100 Percent Effective in Preventing High-Grade Vulvar and Vaginal Lesions Caused by HPV Types 16 and 18

... were used to assess immunogenicity to each vaccine HPV type. These assays measured antibodies against neutralizing epitopes for each HPV type. The scales for these assays are unique to each HPV type; thus, comparisons across types and to other assays are not appropriate. Immune Response to ...

In New Study, Duloxetine Was Equally Effective, Regardless of Switch Method, in Reducing Painful Symptoms in Ssri Non- or Partial-responders with Depression

... Painful physical symptoms were assessed at baseline and at the 10-week study endpoint via a variety of measures including 6 Visual Analogue scales (VAS) for pain, and the Symptom Questionnaire-Somatic Subscale (SQ-SS). Results included: 1 Clinically significant levels of pain (mean ...

Topline Results of Phase III Study in Acute Ischemic Stroke (Dias-2) Do Not Demonstrate Difference Between Desmoteplase and Placebo

... Rankin Scale (MRS) score of 0-2, and (3): Barthel Index (BI) score of 75-100. Only patients who simultaneously met the criteria along all three scales were considered responders. Patients defined as responders by such criteria are in general able to function independently, having no or few deficits. ...

Research Documents Scalable Production, Survival Following Engraftment and Positive Impact on Cardiac Function in Infarcted Rats for Geron's Human Embryonic Stem Cell-Based Therapeutic for Heart Failure

... hESC than conventional "embryoid body-based" protocols. The differentiation protocol produced cardiomyocyte populations of up to 70% purity at scales sufficient to enable both preclinical and early clinical development. Moreover, the final cardiomyocyte product could be cryopreserved and thawed ...
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(Date:7/28/2014)... professor John Essigmann and colleagues from the University of Washington ... if they could induce the virus to mutate uncontrollably, they ... a strategy that our immune system uses against many viruses. ... HIV to mutate at an enhanced rate, as expected. But ... small clinical trial reported in 2011. In a new study, ...
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Breaking Biology News(10 mins):Forced mutations doom HIV 2Forced mutations doom HIV 3Forced mutations doom HIV 4New protein structure could help treat Alzheimer's, related diseases 2New protein structure could help treat Alzheimer's, related diseases 3Seeing is bead-lieving 2
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