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Covance Receives Highest Level of Phase I Accreditation

PRINCETON, N.J., July 30 /PRNewswire/ -- Covance Inc. today announced that it has received standard and supplementary accreditation for the conduct of clinical pharmacology in Europe by the Medicines and Healthcare products Regulatory Agency (MHRA). This voluntary accreditation ...

CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI

TORONTO, June 4 /PRNewswire/ -- The 12-month results from a multicenter trial monitoring CellCept(R) (mycophenolate mofetil) in combination with calcineurin inhibitors (CNIs) in renal transplantation was presented today at the American Transplant Congress (ATC). The study results showed that a...

Kosan's Lead Hsp90 Inhibitor, Tanespimycin, Shows High Level of Activity in Trastuzumab Resistant/Refractory HER2-Positive Breast Cancer in a Phase 2 Trial

Data Presented at ASCO Show 26% Partial Response, 63% Clinical Benefit Incidence HAYWARD, Calif., June 3 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN ) today announced that its lead Hsp90 inhibitor, tanespimycin, demonstrated a high lev...

DATATRAK(TM) Takes Clinical Trial Solutions to the Next Level With the Release of 5.0

New features reduce trial delivery time and ensure faster access to client data CLEVELAND, Jan. 30 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. (Nasdaq: DATA ), a technology and services company focused on global eClinical solutions for the clinical t...

NewCardio Announces Master Services Agreement With Dedicated Phase I

...ness strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our st...

Medigus and Tower Semiconductor Announce World's Smallest Medical Video Camera Based on Advanced CMOS Image Sensor

...ously achievable. Medigus' innovative cameras will support an important unmet market need, giving both physicians and patients the most cost-effective level of technology, without compromising the quality of treatment which they deserve." "We are very excited to work with a leader in the miniature d...

Montefiore Medical Center and Albert Einstein College of Medicine Herald New Agreement To Continue Forty-Plus Year Historic Relationship

... New agreement outlines an increased level of commitment to clinical care, research and education NEW YORK, Ju...nities we serve." The new long-term agreement demonstrates a renewed level of commitment that will align key strategic directions and raise the statur...

Is Your Hair Taking a Break?

... of non-childbearing age only, and the anti-androgens spironolactone and flutamide that work by blocking the male hormone testosterone at the cellular level of the hair follicle. These oral medications also may be an option for women who may not want to spend time applying minoxidil every day. Dr. McMichae...

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

...ent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development.(17,18) The specific etiology of ADHD is unknown and there is no single diagnostic test for this syndrome.(12) Adequate diagnosis requi...

Video: New Dove(R) Body Washes with NutriumMoisture(TM) Restore Skin's Natural Moisture

...ng benefits that strengthen and smooth skin." NutriumMoisture: Most Effective Natural Nourishment Dove NutriumMoisture contains the highest level of natural moisturizers in a body wash, making it the most effective natural nourishment ever. While moisturizers in other body washes sit on top of s...

Octapharma Accepting Applications for Research Grants on Immunotherapy, Coagulation Disorders and Critical Care

...n Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration , providing the highest level of production flexibility and minimizing product shortages. For more information, please visit www.octapharma.com or call Octapharma USA at 201-60...

Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

...a may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX. It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small number of patients, parti...

CareFirst BCBS Covers eNO Measurement for Diagnosis, Asthma Treatment

...re exhaled nitric oxide, a well established indicator of asthma severity and steroid responsive airway inflammation. Measuring eNO and determining the level of airway inflammation can help clinicians more closely manage their patients' inflammatory condition and therefore more precisely titrate medications...

Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations

...ulation, prescribed for a reversible reduction of serum testosterone to the level of castration in adult men suffering from sexual deviations. Developed by D...fficacy and safety profile. Triptorelin decreased serum testosterone to the level of castration in all patients. Concurrent with the decrease in testosterone...

Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations

...ulation, prescribed for a reversible reduction of serum testosterone to the level of castration in adult men suffering from sexual deviations. Developed by D...fficacy and safety profile. Triptorelin decreased serum testosterone to the level of castration in all patients. Concurrent with the decrease in testosterone...

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

...erse event was observed during 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 in the case of the single-dose study. As described above, percutaneous absorption of the drug was not h...

Cardax Pharmaceuticals Nominates Clinical Candidate Heptax for Liver Disease; Heptax Ameliorates Inflammation and Oxidative Stress Related to Liver Disease and Metabolic Syndrome

...tellation of diseases including diabetes, liver disease, and heart disease, often in the same patient, and is referred to as "metabolic syndrome." Low level inflammation and oxidative stress are the mechanistic underpinnings of metabolic syndrome. The Cardax lead compound is a novel and highly bio...

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

...lus standard of care, while the safety profile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level of statistical significance. BENLYSTA also significantly reduced SLE disease activity versus placebo based on a number of other measures, including S...

Oncolytics Biotech(R) Inc. Announces Publication of Research on Synergistic Activity of Reovirus and Chemotherapy in NSCLC

...nergistic effects on cell killing. The combination of reovirus and paclitaxel was invariably synergistic in all cell lines tested, regardless of their level of sensitivity to either agent. The investigators concluded that the oncolytic activity of reovirus can be potentiated by taxanes and other chemothe...

Results From Drug Trials and New Risk Factors Announced at International Alzheimer's Conference

... and diagnosis of Alzheimer's. Phase III Alzheimer's Drug Raises level of a Toxic Protein Recent evidence suggests that the drug Dimebo...suggested that the number of people with Alzheimer's and dementia begins to level off and perhaps even go down a bit in people age 90 and above. P...

Music & Medicine: Unique Collaboration Combines Performing Arts and Science

...ed keyboard] to students," Chesky said. "It's a major departure from the norm and hugely significant because many people pursuing piano at the college level are Asian females. But this population has smaller hands than the average male, for whom standard pianos were designed. "It's like someone w...

deCODE Discovers Second Common Genetic Risk Factor for Atrial Fibrillation and Stroke

...hose relating to our ability to obtain sufficient financing to continue as a going concern, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identif...

Shoulder Surgery Doesn't Prevent Return to Sports

...for periods greater than 30 minutes per session with the same type of intensity. It also appears that the most likely reason for returning to the same level of participation is dependent on the motivation of the individual. Athletics can be a great motivator for surgery and an even greater one for patients...

ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients

...sthma may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX. It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small number of patients, parti...

St. Francis Surgeon Uses Tissue Regeneration Technology to Rebuild Patients' Heart Structures

... major advancement in cardiac surgery and allows us to provide our patients with restoration of normal anatomic structures. It opens the door to a new level of cardiac tissue reconstruction," said Gerdisch, director of cardiothoracic surgery at the St. Francis Heart Center and a partner at Cardiac Surgery ...

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'

...ing their neuronal calcium," says Underwood. "We are very optimistic that the same compound can now be tested on Alzheimer's patients to assess their level of cognitive improvement." ABOUT QUINCY BIOSCIENCE ( www.quincybioscience.com ) Quincy Bioscience is a biotech company located in Madison,...

Thiarabine Demonstrates a Reduction of Both Inflammatory and Erosive Disease Parameters in Rheumatoid Arthritis

...loss of cartilage matrix proteins. When used as a preventative treatment, thiarabine blocked the development of joint disease at the 60 mg/kg/day dose level and exhibited a significant reduction in disease incidence and severity at 20 mg/kg/day. In a therapeutic study comparing thiarabine to methotr...

deCODE-led Megastudy Finds New Genetic Clues to Causes of Schizophrenia

...hose relating to our ability to obtain sufficient financing to continue as a going concern, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identif...

SUNY Youth Sports Institute Convenes Top Experts in NYC Next Week to Present Research & Analysis on Energy Drink Health Impacts

... SUNY Youth Sports: The SUNY Youth Sports Institute training network is called Youth Sports NY . It works with 29 SUNY Community Colleges and 50 high level coaches as trainers. Since March 2008 the program has trained over 2,000 non-school volunteer youth coaches in New York State to a common minimum coac...

MJFF's Rapid Response Innovation Awards Hit Mid-2009 With Over $1 Million Funded in High-Risk/High-Reward Approaches to Parkinson's Disease

... " Rapid Response enables us to assess the best new ideas in real time, quickly vet their potential, and move the most promising ones to the next level fast," said Katie Hood, CEO of MJFF. "This reflects our commitment to keep fresh ideas flowing into the Parkinson's therapeutic pipeline, as well as o...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

...ebo. Of those patients receiving sodium oxybate treatment, 35 percent of patients on 4.5 g/night and 35 percent of patients on 6 g/night reported this level of pain relief on the Pain VAS, compared with 20 percent of patients on placebo. These results were highly statistically significant. Patients' p...

Acute Lymphoblastic Leukemia, the Most Common Childhood Cancer, Is Curable Without Preventive Cranial Radiation

...al disease) that were present after remission induction treatment. The measurement of minimal residual disease was used to modify therapy based on the level of disease detected. This measurement is the most important prognostic indicator, according to Dario Campana, M.D., Ph.D., vice chair for laboratory r...

Spherix Announces Positive Phase 2 Study Results

...ree different doses, 2.5, 5.0, and 7.5 g. Patients were required to pass specific inclusion criteria at screening and at baseline, including an HbA1c level at screening and baseline between 6.6% and 9.0%. The baseline visit followed an 8-week run-in period in which patients were instructed to follow a we...

West Wireless Health Institute Teams with Corventis for its First Multicenter, Randomized Clinical Trial

... Corventis will work closely with the Institute's clinical research and wireless engineering teams to ensure the research devices improve the existing level of care, and are safe, reliable and cost effective. Don Jones, vice president of Health and Life Sciences at Qualcomm, and the Institute's chief wire...

Salvacyl(R), Developed by Debiopharm, is Launched in two European Countries

...in, a gonadotropin releasing hormone (GnRH) agonist analogue. The product will be prescribed for the reversible reduction of serum testosterone to the level of castration in order to lower sexual drive in adult men suffering from sexual deviations. "This is a great accomplishment for Debiopharm. Sal...

School of Dentistry Studies Link Between Oral Health and Memory

... memory loss. A blood draw is also part of the study for research subjects who agree. "If you have a gum infection, you'll have an increased level of inflammatory byproducts," Crout explained. "We're looking for markers in the blood that show inflammation to see if there is a link to memory probl...

New Bisphenol A Study Is of Very Limited Relevance to Human Health

...rectly, that their study is significant because it used a dose equal to the EPA reference dose for BPA, which is a science-based lifetime daily intake level determined to be safe by EPA. However, the EPA reference dose is specifically applicable only to oral exposure, not to injection exposure. Consequen...

New Studies Presented at European Society of Anaesthesia Further Validate Masimo PVI(TM) for Noninvasive and Continuous Fluid Monitoring

...ures for hernia surgery changed in response to the level of spinal block reached. PVI was recorded in all ...as performed. In patients reaching the anesthetic level C-area--identified as the high spinal block group-...that Masimo SpHb and PVI will provide a sufficient level of sensitivity and specificity to facilitate conti...

Data Demonstrated ACTEMRA(R) (tocilizumab) Significantly Inhibited Progression of Structural Joint Damage in Rheumatoid Arthritis Patients

...ormation from 28 tender and swollen joints (range 0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28 less than or equal to 3.2), moderate (3.2<DAS28 less than or equal to 5.1) or high (DAS28>5.1)....

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

...e collected again at weeks eight and sixteen(3). Tadalafil increased 6MWD in a dose-dependent manner, only the 40 mg dose met the pre-specified level of statistical significance of less than 0.01 (p<0.01). Overall, the placebo-corrected treatment effect was 33m (95 percent confidence-interval, 15...
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