Neurocrine Biosciences Presents Elagolix Data

... cell immunohistochemistry. The data reveal that transient inhibition of plasma testosterone and ... preclinical results are replicated in men, daily transient inhibition of androgens with a GnRH antagonist ... endometriosis, these products cause an initial, transient heightening in symptom severity, as well as hot ...

ARVO, AOS: Large Study of Lacrisert(R) Dry Eye Insert;

... . Most adverse reactions with Lacrisert were mild and transient and included transient blurring of vision, ocular discomfort or irritation, matting or stickiness ...

Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals' Circadian Regulator Tasimelteon (VEC-162) Published in The Lancet

... et al(1) is entitled "Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre ... Shantha M.W.; et al. "Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomized controlled multicentre ...

Phase III Data Show Vanda Pharmaceuticals' Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia

... and TST (by 33.7 to 47.9 minutes compared to placebo) in a model of transient insomnia. Taken together, the results of both of these studies demonstrate ... treat the symptoms of insomnia acutely and chronically both in a model of transient insomnia and in patients with chronic primary insomnia. "These results ...

Micromet's BiTE Antibody Blinatumomab (MT103/MEDI-538) Demonstrates Durable Responses in Patients with Relapsed Non-Hodgkin's Lymphoma

... lymphopenia, pyrexia, and leukopenia. Less common adverse events included transient neutropenia and thrombocytopenia, transient increase of liver enzymes, and central nervous system events, all of which ...

PRoFESS(R) Results Announced at XVII European Stroke Conference

... United States,(4) and 21.5 percent of people who survive a first stroke or transient ischemic attack (TIA or "mini stroke"), will experience another episode ... dipyridamole to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. ...

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

... common side effects being sedative in nature.(1,2) Sedation-related, treatment-emergent adverse events were among the most common and were usually transient and mild to moderate in severity.(1,2) Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 ...

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

... (ADCIRCA or CIALIS) should not take ADCIRCA. PDE5 inhibitors, including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular ...

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

... of treatment with bcr-abl inhibitors, and patients with t(4;11) translocations. Side effects were observed primarily in the first 24 to 48 hours with transient pyrexia and lympho-/leukopenia being the most frequent adverse events. "Blinatumomab is one of the most active agents the GMALL has tested in ...

FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension

... or CIALIS) should not take ADCIRCA. PDE5 inhibitors, including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular ...

Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms

... most common side effects being sedative in nature. Sedation-related, treatment-emergent adverse events were among the most common and were usually transient and mild or moderate in severity. Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 percent), ...

Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results

... If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has ...

New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure

... If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has ...

New Studies Show Popular Heartburn Medications Moderate the Effect of Taking Widely Prescribed Heart Drug

... the four most popular PPIs." The adverse cardiovascular events that were measured in the study include myocardial infarction, unstable angina, transient ischemic attack/stroke, coronary revascularization or cardiovascular death. The analysis is one of a series by Medco and Indiana University ...

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

... infarction, angina, pericardial effusion, retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, optic neuritis, transient ischemic attack, supraventricular arrhythmias, loss of consciousness; neutropenia, infection (sepsis, pneumonia, abscess, cellulitis); emphysema, ...

InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)

... and indirect bilirubin elevation. Neutropenia occurred with a similar pattern, frequency and severity in the placebo and ITMN-191 groups. Minor and transient elevations in indirect bilirubin levels were observed in a small number of placebo and ITMN-191 patients and were deemed not clinically significant ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... infarction, angina, pericardial effusion, retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, optic neuritis, transient ischemic attack, supraventricular arrhythmias, loss of consciousness; neutropenia, infection (sepsis, pneumonia, abscess, cellulitis); emphysema, ...

YM BIOSCIENCES ANNOUNCES NIMOTUZUMAB PRESENTATIONS TO BE MADE AT THE 100TH ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH AND EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY

... cells because it is capable of monovalent binding to very low expressions of EGFR whereas nimotuzumab's monovalent binding is transient. It is this transient monovalent binding that results in its benign safety profile. Both antibodies bind definitively when binding bivalently. The poster presentation ...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

... infarction, angina, pericardial effusion, retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, optic neuritis, transient ischemic attack, supraventricular arrhythmias, loss of consciousness; neutropenia, infection (sepsis, pneumonia, abscess, cellulitis); emphysema, ...

Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

... with ITP. Currently available treatments (i.e., corticosteroids, immunoglobulins) have limited application due to poor tolerability or transient effects. Surgical therapy (removal of the spleen) is also available to adult patients with chronic ITP, but does not work in all cases. Currently, ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... with ITP. Currently available treatments (i.e., corticosteroids, immunglobulins) have limited application due to poor tolerability or transient effects. Surgical therapy (removal of the spleen) is also available to adult patients with chronic ITP, but does not work in all cases. Currently, ...

Sosei Confirms the Safety of SD118 in Two Phase I Trials

... due to its unresponsiveness to most of the pain-killers, anticonvulsants, antidepressants and in some cases, opioids. Paraesthesia A transient sensation of numbness or tingling ["pins and needles"]. Hypoaesthesia A reduced sense of touch. About Sosei Sosei Group is ...

GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP

... bleeding, particularly if PROMACTA is discontinued while the patient is on anticoagulants or antiplatelet agents. In the controlled clinical studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 10% and 6% of the PROMACTA and ...

Do You Know You're Having a Stroke?

... . Researchers studied 400 patients who were diagnosed at Mayo Clinic's emergency department with either acute ischemic stroke or a transient ischemic attack (TIA), a temporary interruption of blood flow to part of the brain. Less than half of the patients -- 42 percent -- thought ...

Nplate(TM) (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union

... with ITP. Currently available treatments (i.e., corticosteroids, immunoglobulins) have limited application due to poor tolerability or transient effects. Surgical therapy (removal of the spleen) is also available to adult patients with chronic ITP, but does not work in all cases. Currently, ...

FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder

... bleeding, particularly if PROMACTA is discontinued while the patient is on anticoagulants or antiplatelet agents. In the controlled clinical studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 10% and 6% of the PROMACTA and ...

Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months

... levels, glucosuria, increased appetite, dizziness, akathisia, parkinsonism, dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases, rash, asthenia, fatigue and oedema. About Lilly Lilly, a leading innovation-driven corporation, ...

Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing

... of hyptertrophic burn scar formation with the use of collagenase, an enzymatic debriding agent. Wound, 2005; 17[12]: 332-336. *Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound. One case of systemic hypersensitivity has been reported after 1 year of ...

Ardea Biosciences Presents Phase 2a Antiviral Activity Data for Lead HIV Candidate, RDEA806 at XVII International AIDS Conference

... incidence of CNS side effects was similar between drug and placebo. Gastrointestinal side effects were most common, but these effects were generally transient and mild. The presentation is available on the conference website ( http://www.aids2008.org ) and on the Company website ( http://www.ardeabio.com ...

Diverse Approaches to Alzheimer's Therapies Continue to Show Progress at ICAD

... improvements. Treatment-related adverse events that occurred at a greater frequency with IVIg treatment as compared to placebo were rash and a transient drop in blood count. In contrast, there were more behavioral disturbances in placebo-treated patients than those who received IVIg. "While there ...

Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing

... placebo. Administration of the highest dose on an empty stomach showed an increase in gastrointestinal side effects, but these effects were generally transient and mild. -- There were no premature discontinuations in any cohort. -- Based on the results generated in this trial, the doses planned for the ...

NeurogesX Announces Publication of NGX-4010 Phase 3 HIV-Neuropathy Study Results in Neurology

... significant reduction in pain over a 12-week period. The NGX-4010 application was well tolerated with the most common side effects being transient application site reactions. About NeurogesX, Inc. NeurogesX (Nasdaq: NGSX ) is a biopharmaceutical company focused on developing and ...

Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight

... once weekly and with BYETTA use were limited to patients using background sulfonylurea therapy. In both groups, nausea was predominantly mild and transient and occurred less frequently in the exenatide once weekly patients. Twenty-six percent of patients receiving exenatide once weekly reported nausea ...

New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study

... addition, few patients discontinued treatment due to adverse events (1.8-11.1% with once daily versus 1.8% with placebo). Adverse events included transient dose-dependent nausea (from 7,3 to 33,3% with 5 micron(g) once daily and 30 micron(g) twice daily, respectively versus 4.6% with placebo). No cases ...

Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytren's Contracture

... The most common adverse events reported in the CORD I and II and PK studies were pain, swelling, bruising and pruritis at the injection site and transient lymph node swelling and pain. These adverse events were consistent with previous trials. No systemic allergic reactions were noted. In data from ...

Karmanos Cancer Institute Researchers Show Phase I Immunotherapy with Armed T Cells Improve Overall Survival of Metastatic Breast Cancer Patients

... have improved the patients' longevity and quality of life without undue toxicities. The predominant side effects were chills, fever, headaches, and transient hypotension that were controlled with medications and fluid support." "It appears that infusions of targeted T cells have boosted the immune system ...

BioVex Reports Positive Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting

... Seven patients remain on study with stable disease 3 to 10 months post initiation of therapy. Side effects were mild and mainly limited to transient flu-like symptoms. Commenting on these results, Dr. Neil N. Senzer of the Mary Crowley Cancer Research Center in Dallas, TX said: "Patients with ...

TARGETED GENE DELIVERY SIGNALS CANCER VACCINATION IN VIVO: Intravenous Infusions of Rexin-G Followed by Reximmune-C Induce Tumor Necrosis and Recruitment of Tumor Infiltrating Lymphocytes in Cancerous Lesions (ASCO 2008)

... function, bone marrow suppression, liver, kidney, or any other organ dysfunction related to the intervention. Immune-related reactions consisted of transient flu-like symptoms in two patients, redness and swelling of a tumor-infiltrated lymph node and one metastatic chest nodule, and acute flank pain in ...

Watson Announces Positive Data for Its New Investigational Products for Benign Prostatic Hyperplasia and Overactive Bladder

... events occurring in patients were hot flushes, skeletal pain, impotence and headache. As with all LHRH agonists, triptorelin causes an initial transient increase in testosterone levels and may initiate or worsen symptoms during this transient period. Rare post-marketing reports of anaphylactic shock ...

Shire's Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose

... in nature. Sedation-related, treatment-emergent adverse events were among the most common but emerged in the first two weeks and were usually transient and mild or moderate in severity. Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 percent), ...