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Retigabine Significantly Reduces the Number of Seizures in Adults With Inadequately Controlled Partial-Onset Epilepsy

SEATTLE, Dec. 6 /PRNewswire-FirstCall/ -- Results from RESTORE 2, a placebo-controlled, Phase III study demonstrated that the investigational compound retigabine significantly reduced the number of seizures in adult patients with refractory partial-onset epilepsy when a 600 mg or 900 mg dose was a...

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

- Results demonstrate clinically significant reduction in allergic asthma attacks and further define Xolair safety profile in children age six through 11 - this includes 11-year-old children, up to their 12th birthday - Xolair is the only approved therapy to block IgE, which is associated wi...

Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD

In a clinical study of adults, VYVANSE taken once-daily significantly improved the symptoms of ADHD within one week PHILADELPHIA, Oct. 7 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that a study published in th...

Established Safety Profile of Spiriva Confirmed by 30 Rigorously Controlled Clinical Trials and the Landmark Trial UPLIFT

New Data from Landmark UPLIFT Trial Further Supports Spiriva's Safety Profile RIDGEFIELD, Conn. and NEW YORK, Sept. 23 /PRNewswire/ -- Boehringer Ingelheim and Pfizer Inc have released a new analysis of 30 rigorously controlled clinical trials, including UPLIFT, confirming the long term safe...

Ekkyo Describes the First Benefits of Controlled Hyperthermia in Humans in "Lasers in Surgery and Medicine"

A Pilot Study Suggests That Ekkyo's New Approach of LASH (Laser Assisted Scar Healing) can Drastically Improve Scar Healing Physiology MARSEILLES, France, July 22 /PRNewswire/ -- Ekkyo (formerly known as Heatwave Technology) a photomedicine company, which develops first-in-class laser-base...

Randomized Controlled Clinical Trial Shows Derma Sciences MEDIHONEY(TM) Eradicates MRSA From Chronic Venous Ulcers

70% Elimination Of The Deadly Superbug Provides Hope For Global Caregivers PRINCETON, N.J., June 17 /PRNewswire-FirstCall/ -- Derma Sciences (OTC Bulletin Board: DSCI), a provider of advanced wound care products, announced today that its key product, MEDIHONEY(TM) Wound & Burn Dressing with Act...

Safety and Efficacy Results Presented From Largest Prospective Controlled Clinical Study of Ulcerative Colitis

4.8 g/day dose using investigational 800 mg tablet demonstrated efficacy and was well tolerated in ASCEND III study SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- In a study presented today at the 39th Annual Digestive Disease Week (DDW) meeting in San Diego, California, 70 percent ...

Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipolar Disorder

Shows Treatment Significantly Effective at Eight Weeks CINCINNATI, Oct. 26 /PRNewswire/ -- In the largest pediatric study of its kind on mood stabilizers, scientists from Cincinnati Children's Hospital Medical Center and two other centers demonstrated that divalproex sodium (Depakote(...

Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics' Hypertension Better Controlled With Equal Access to Care

DALLAS, Sept. 12 /PRNewswire/ -- With equal access to medical care and medication, Hispanic men and women have as good or greater chance as non- Hispanics of controlling their high blood pressure. When researchers studied blood pressure control in Hispanics as part of the ALLHAT (Antihypertens...

Once Daily, Extended-Release Ropinirole Improves Parkinson's Symptoms in Patients not Optimally Controlled With Levodopa

'Off' Time Reduced By an Average of More Than Two Hours Per Day RESEARCH TRIANGLE PARK, N.C., April 02, 2007 /PRNewswire/ -- Adding the once daily, investigational medication REQUIP(R) (ropinirole HCl) XL 24-Hour(TM) Extended-Release Tablets to Parkinson's patients' existing levodopa (L-dopa) ther...

First Controlled Large-Scale Intervention Angiotensin Receptor Blocker (ARB) Trial in a Japanese Population, JIKEI HEART Study Demonstrates Significant Reduction in Blood Pressure and Protection of Organs with Valsartan

Unprecedented Evidence for the Effectiveness of Hypertension Treatment Valsartan in Preventing Cardiovascular Events in Japanese Patients TOKYO, April 26, 2007 /Xinhua-PRNewswire/ -- The clinical outcomes of the JIKEI HEART Study, the large-scale clinical trial headed by the Jikei University Schoo...

Halozyme Therapeutics' Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society

- Co-Injection of rHuPH20 with Humira Estimated to Increase the Maximal Steady State Subcutaneous Bioavailability from 64% to 100% - SAN DIEGO, July 09, 2007 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing recombinant human enzymes...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

...Canada." Labopharm's NDS is based on data from five pivotal pharmacokinetic studies and the positive results from a North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients. The eight-week randomized, double-blind, two-arm, multi-centre Phase III s...

Study Shows Brain Fitness can Save Medicare Billions

...ties to design and test its interactive computer-based programs. More than 30 articles in leading science and medical journals show that in randomized controlled trials the company's patented technologies significantly increase processing speed, improve memory and attention and enhance quality of life. Posit Sc...

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

... upcoming medical meeting in the second half of this year. Study Design This was an international Phase 3, randomized, doubleblind, active controlled study comparing denosumab with Zometa in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or m...

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

... INTUNIV is a once-daily, extended release formulation of guanfacine, designed to provide steady delivery of drug throughout the day. INTUNIV is not a controlled substance and has no known potential for abuse or dependence. Guanfacine, the active ingredient in INTUNIV, is thought to work directly by bind...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

...ir dose of blood pressure medications adjusted or initiated, their blood pressure was successfully reduced and their blood pressure was generally well controlled throughout the trial. The blood pressure medications were standard doses of common blood pressure medications such as ACE inhibitors or diuretics. ...

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

...LIZER should only be used as additional therapy for patients not adequately controlled on other asthma controller medications. FORADIL AEROLIZER is not i...RADIL should only be used as additional therapy for patients not adequately controlled on other asthma controller medications. In asthma clinical trials...

Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

...conducted under a Special Protocol Assessment with the FDA. The Company reached its enrollment target in this international, multi-center, randomized, controlled trial in March 2009. Poniard is also evaluating picoplatin in a Phase 2 clinical trial in patients with colorectal cancer and in a Phase 2 clinical tr...

Cytokine PharmaSciences Initiates Phase I Study of Oral Anti-Inflammatory Agent, CPSI-2364

...flammatory and autoimmune therapeutics. The Company is headquartered in King of Prussia (near Philadelphia), Pennsylvania. A wholly owned subsidiary, controlled Therapeutics (Scotland) Limited (CT), is located in East Kilbride (near Glasgow). CT develops and manufactures controlled-release drug delivery produ...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

... days. The study enrolled 42 influenza patients at high-risk of serious complications due to one or more qualifying conditions: diagnosis with poorly controlled diabetes mellitus, a chronic respiratory disease requiring pharmacotherapy, or current treatment with any immunosuppressive drug. Peramivir was admin...

Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease

... the additional sections are completed and submitted for review. Shire is completing a phase III clinical program that includes three phase III controlled studies involving over 100 patients at 24 sites in 10 countries around the world. On July 6th, Shire announced that it filed a treatment protoc...

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

... compared with 7% of the placebo patients. The blood pressure was successfully reduced in these patients, and their blood pressure was generally well controlled throughout the trial. The blood pressure medications were standard doses of common blood pressure medications such as ACE inhibitors or diuretics. ...

Why Do African-Americans Fare Worse With Cancer? Access and Economics Are Only Part of the Story

...identical medical treatment and other confounding socioeconomic factors are controlled for. The finding points to biological or host genetic factors as the poten...niversity of Michigan . Using data from clinical trials, which are already controlled for a range of potentially confounding factors such as differences in diagn...

June 2009 Mayo Clinic Women's HealthSource Highlights Summer Skin Problems, Low Vision and Pilates

...nd a series of springs and pulleys that allow progressive exercises to strengthen all muscle groups. A typical Pilates session includes a set of controlled stretches and movements, with participants concentrating on breathing, precision and flowing movements. Instead of emphasizing quantity, Pilates focus...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

...te: http://www.bioheartinc.com/news.php#060409 After reviewing supporting pre-clinical data dating back to 1988 and clinical data from controlled studies which began in early 2000 (nearly 400 patients), a panel of experts strongly endorses moving forward to complete the final phase of clinical t...

5-Year Study Published in Diabetologia Demonstrated Long-Term Safety of Lantus(R) Compared to NPH

...nopathy and overall safety in the two treatment groups. This is the longest controlled study ever reported using insulin glargine. Diabetic retinopathy is a ...nsulin within the eye. "This 5-year study is the longest randomized controlled study with insulin glargine versus NPH human insulin ," said lead inves...

Accumetrics, Inc. Announces GRAVITAS Trial 50 Percent Enrolled

... value of providing clinicians with actionable information for patients who are poor responders to clopidogrel (Plavix(R)). The multi-center, placebo controlled trial will determine whether tailored antiplatelet therapy for poor responders, identified based on the results of the company's VerifyNow P2Y12 Test,...

Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

...he active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at ...

New Data Supports Significant Economic and Clinical Value of MENOPUR(R) in IVF

... AN, et al. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Human Reproduction 2006 Dec; 21(12):3217-27. 5. Platteau et al. Reprod Biomed Online 2008; 17:190-8. ...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

...ss for Epilepsy in Budapest, Hungary. Patients not controlled with existing anti-epileptic drugs who were given ...in reducing partial-onset seizures in patients not controlled with one of the most commonly used anti-epileptics...has been demonstrated in three randomised, placebo controlled studies in 1049 patients with refractory partial o...

Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

...rse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining ...

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

...ugh week 16 was upper respiratory tract infection (7.2 percent of SIMPONI-treated patients compared with 5.8 percent in control-treated patients). In controlled Phase 3 trials through Week 16 in RA, PsA and AS, 5.8 percent of SIMPONI treated patients had injection site reactions compared with 2.2 percent in co...

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

...on of approved high-blood pressure drug isradipine as a neuroprotective approach to PD, which is currently being tested with MJFF support in a Phase 2 controlled clinical trial. The Michael J. Fox Foundation is dedicated to ensuring the development of better treatments, and ultimately a cure, for Parkinson...

New Study Shows that Prebiotics, as Used by Jackson GI Medical, Increases Lifespan by 33%

...versity Journal), clearly shows that Prebiotics reduce cholesterol and triglycerides, control body weight, and increase lifespan by 33%. The controlled clinical study was conducted on rats and showed that the rats fed prebiotics had an 80% survival rate to 24 months versus a 50% survival rate for the ...

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

...de oncologists in the mid-1960s," said Ching-Hon Pui, M.D., chair of the St. Jude Department of Oncology and an American Cancer Society Professor. "It controlled CNS leukemia and boosted the cure rate for ALL from only 4 percent to 50 percent. But radiation's side effects led to the steady reduction of dosages ...

Spherix Announces Positive Phase 2 Study Results

...es. The most common adverse events reported in the trial were mild and gastrointestinal in nature. Prior Studies with Naturlose A recent controlled animal study demonstrated that, in comparison to sucrose, equivalent substitution of Naturlose as dietary carbohydrate results in less obesity, hyperg...

Brain Fitness Makes Boomers Age Younger

...n what we typically think of as mental stimulation." In the randomized controlled trial of 486 older adults, researchers found that those who trained with th.... More than 30 leading science and medical journals show that in randomized controlled trials the company's patented technologies significantly increase processin...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

...eatment of individuals with recent-onset type 1 diabetes. The PROTEGE trial is a randomized, double-blind, multi-center, multi-national, 4-arm, controlled study designed to evaluate the safety and efficacy of teplizumab in individuals with recent-onset type 1 diabetes, aged 8 to 35, who are within 12 wee...

When It Comes to Natural Remedies for Hormonal Balance, the Proof Is in the Clinical Research

...ody's ability to balance (either increase or decrease) levels of its own hormones. Passing stringent pharmacology, toxicology and double blind placebo controlled clinical trials for health and safety, Femmenessence is as safe and side effect-free as your own hormones have been throughout your life. However...
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