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FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

EAST HANOVER, N.J., July 21 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Tekturna HCT((R)) (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Tek...

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

Phase 3 PROTEGE ENCORE Clinical Trial Initiated ROCKVILLE, Md. and INDIANAPOLIS, June 16 /PRNewswire/ -- MacroGenics, Inc. and Eli Lilly and Company (NYSE: LLY ) today announced that the PROTEGE trial achieved its targeted patient enrollment. The trial is a pivotal Phase 2/3 clinical study...

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

- With half as many injections, in two pivotal Phase 3 trials, Albuferon (albinterferon alfa-2b) met the primary efficacy endpoint of sustained virologic response comparable to Pegasys (peginterferon alfa-2a) - - Patients receiving 900-mcg Albuferon had comparable rates of serious and...

Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma

SEATTLE, Feb. 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that updated safety and efficacy data from the phase III trial of pixantrone provides further support for a robust clinical benefit for pixantrone when used as single agent therapy in the ...

Vical Pandemic Influenza Vaccines Achieve T-Cell Responses and Cross-Clade Reactivity in Humans

LAS VEGAS, Dec. 11 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL ) today announced that the company's Vaxfectin (R)-formulated H5N1 pandemic influenza DNA vaccines induced T-cell responses against a matching strain of influenza virus and demonstrated cross-clade antibody response...

TriMix Gel Achieves Success Among Men Who Have Failed to Achieve Erections With Viagra, Levitra and Cialis Type Tablets

ORLANDO, Fla., June 5 /PRNewswire/ -- New research presented at the recent American Urological Association Conference by Urologist Joel L. Marmar, M.D., showed that among men who previously failed to achieve erections on Viagra, Levitra and Cialis type tablets, 40% achieved an erection suffici...

Human Genome Sciences Modifies Dosing in Achieve Trials of Albuferon(R)

ROCKVILLE, Md., Jan. 23 /PRNewswire-FirstCall/ -- Human Genome Sciences Inc. (Nasdaq: HGSI ) announced today that it will modify the dosing in one arm of each of its ACHIEVE clinical trials of Albuferon(R) (albinterferon alfa-2b) for chronic hepatitis C. Patients in the Phase 3 trials who hav...

MDS Patients on Five-Day Vidaza(R) Dosing Schedules Achieve Transfusion Independence Consistent with Seven-day Schedule

Three Alternative Five-day Dosing Schedules Appear Similar to Seven-Day in Achieving Red Blood Cell Transfusion Independence, Hematologic Improvement in All MDS Patients Tested Data Presented at the 49th American Society of Hematology (ASH) Meeting ATLANTA, Dec. 11 /PRN...

Genasense Plus Chemotherapy Is Associated With Prolonged Survival in Patients With Relapsed/Refractory CLL Who Achieve Complete Remission

Updated Phase 3 Results Released at American Society of Hematology Meeting BERKELEY HEIGHTS, N.J., Dec. 10 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA ) announced the release of new survival analyses based upon extended follow-up of patients in the Company's randomized Phase 3 t...

New Analysis from 14 Countries Identifies Drug Access Priorities to Achieve 2010 AIDS Treatment Target

Dr. Jim Kim joins teleconference to release report with ITPC. Kim says foundations laid by AIDS response are "the best chance we've ever had to build comprehensive health systems in the poorest settings." NEW YORK AND CAPE TOWN, South Africa, Nov.27 /PRNewswire-USNewswire/ -- The Internati...

Powerful New Efficacy Data in Moderate and Severe Hypertensive Patients Supports FDA Approval of AVALIDE(R) (Irbesartan-Hydrochlorothiazide) as the First Combination Therapy for Initial Use in Patients Likely to Need Multiple Drugs to Achieve Their Blood

AVALIDE demonstrated powerful mean blood pressure reductions of 30.8 mm Hg systolic blood pressure (SBP) and 24.0 mm Hg diastolic blood pressure (DBP) at five weeks and 21.1/19.3 mm Hg (SBP/DBP) for irbesartan alone in a study of patients with severe hypertension AVALIDE also de...

Tiny Cup Attached to Eye Improves Drug Delivery For Retinal Diseases

...noblastoma, a cancer affecting one in 15,000 children, must now be given intravenously. This requires relatively large doses of the drug are needed to achieve a therapeutic concentration in the retina. The chemotherapy destroys the bone marrow and depresses the child's immune system, often leading to seconda...

NOVAVAX Achieves Pandemic H1N1 Influenza Production Milestone

...ential to expand vaccine surge capacity and significantly reduce the timeline for vaccine release. We are proud of our staff who worked tirelessly to achieve this important milestone while working concurrently to produce materials for a clinical study in the elderly population with our Seasonal Flu vaccine....

Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program

... clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), its ability to achieve clinical and commercial success and its ability to successfully develop marketed products. These statements are subject to numerous risks, including b...

OPAXIO(TM) Combined with Alimta(R) Well Tolerated in Dose-Ranging Study of Patients with Advanced Non-Small Cell Lung Cancer

...cal industry in general, and with OPAXIO in particular, including, without limitation, the potential for OPAXIO to be proved safe and effective (or to achieve response rates) for the treatment of the indications noted in this press release or any other indication, determinations by regulatory, patent and adm...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

...f its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to ...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

...Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) I...at weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii) About Amylin, Lilly and Alk...

Reliv International's GlucAffect(TM) Proven Effective in Clinical Study

...bo group," said Dr. Carl Hastings, Reliv's vice chairman and chief scientific officer, who is a Ph.D. in food science. "GlucAffect enabled subjects to achieve healthy weight and blood sugar levels after eight weeks," Hastings added. Elevated weight and blood glucose levels are key factors in metabol...

New Research Shows: Neurofeedback is an 'Evidence-Based' Treatment for ADHD

...n and Neurofeedback for the treatment of ADHD. Employing applied Brain research Brainclinics strives to improve and personalize treatments in order to achieve more efficacious clinical outcomes (also called Personalized Medicine). ...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

... increased survival, approximately half of all children with malignant solid tumors will experience relapse and, of these children, less than 10% will achieve long-term survival after standard multimodal therapy. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals is focused on ...

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

... by a qualified instructor. Success with Pilates depends on precision of movement and effort. Proper instruction is key to knowing how to exercise and achieve the benefits. Mayo Clinic Women's HealthSource is published monthly to help women enjoy healthier, more productive lives. Revenue from subscrip...

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

... clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), its ability to achieve clinical and commercial success and its ability to successfully develop marketed products. These statements are subject to numerous risks, including b...

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

...the scores at study end were similar in both treatment groups (Lantus(R): 14.2%, NPH: 15.7%; 95% CI: -7.02, 3.06). As per protocol, the study aimed to achieve similar levels of glycemic control in both groups, in order to avoid introducing bias on the primary retinopathy end-point that could be related to di...

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

...cement and major abdominal surgery studies demonstrate that a wide variety of patients experiencing moderate-to-severe post-operative pain are able to achieve significant pain relief with our non-invasive approach to patient-controlled analgesia utilizing sublingual Sufentanil NanoTabs. We are pleased with t...

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

...a constant challenge and up to 40% of patients with partial seizures do not achieve seizure control with current anti-epileptics(2). Additional studies ...nstant challenge - up to 40% of patients with partial-onset seizures do not achieve seizure control with current anti-epileptic drugs(2). Furthermore, a...

Commonwealth Fund Case Study Points to 'Continuous Innovation' at Group Health Cooperative

... Peer Review and Teamwork for High-Value Care A mission-driven, values-based organizational culture brings people together to achieve higher performance. Clinical dashboards communicate comparative physician performance. Performance-based pay rewards achievement on quality, ...

ADHD Genes Found; Known to Play Roles in Neurodevelopment

...cific genes in neurological conditions, the hope is that researchers might in the future personalize treatments to a patient's own genetic profile, to achieve more targeted, specific therapies. Elia and White stressed that much further work must be done before genetic findings lead to ADHD treatments. ...

Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th

...ith pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective (including the failure to achieve the overall response rate, complete remissions and progression-free survival and the possibility of significant grade 3, 4 adverse effects, including ...

Alfacell Provides Shareholder Update

...ry endpoint of overall survival in our Phase IIIb clinical trial in patients suffering from unresectable malignant mesothelioma (UMM). We did however; achieve statistical significance with a subgroup of patients who failed a prior chemo therapy. Overall survival was 10.5 months for this group. As we reported...

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

...Council (ACC) and its member companies have long-supported research to advance scientific understanding about chemicals and promote public health. To achieve these goals with limited resources, including limited use of laboratory animals, study designs should be based on sound scientific principles and data...

Value of Genetic Testing for Preventing Blood Clots Unproven, According to New AHRQ Study

...ile genetic testing shows great promise to improve treatment and prevent disease, this report clearly shows that we need more research and evidence to achieve its full potential," said AHRQ Director Carolyn M. Clancy, M.D. "But people can help reduce their likelihood of developing a blood clot by talking wit...

Study Demonstrates Efficacy of Pitavastatin in Elderly Patients

...ry hypercholesterolemia or combined dyslipidemia who are taking other medications, and this study demonstrates that the majority of these patients can achieve and sustain goal with the starting dose of 2 mg of pitavastatin once daily." About pitavastatin Pitavastatin (a statin) is a fully synthetic...

ThermoGenesis Announces National Institute of Health Grant

...is to provide an integrated cell processing and delivery system designed to achieve an optimal therapeutic effect in orthopedic applications, such as bone repa...d result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2009. A more complete description o...

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

...ell transplantation centers in the US and France. Although orBec(R) did not achieve statistical significance in the primary endpoint of its pivotal trial, name...ian time-to-treatment failure through Day 50 (p-value 0.1177), orBec(R) did achieve statistical significance in other key secondary endpoints such as the propo...

New Poll Finds Disease Prevention is Top Priority for Americans in Health Reform

...ving the health and health care of all Americans, the Foundation works with a diverse group of organizations and individuals to identify solutions and achieve comprehensive, meaningful and timely change. For more than 35 years the Foundation has brought experience, commitment, and a rigorous, balanced approa...

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

...Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) I...at weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii) About BYETTA(R) (exenatide) in...

Tolerx Presents Data at 69th Scientific Sessions of the American Diabetes Association

...onal antibody, causing partial TCR modulation, are efficacious in this model, and that high doses resulting in full TCR modulation are not required to achieve similar rates of remission. These data, combined with a rigorous Phase 2 clinical development program assessing more than 10 dosing regimens, h...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

...ny additional markets, or that Afinitor will be approved for any additional indications or labeling. Nor can there be any guarantee that Afinitor will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Afinitor could be affected by, among other things, ...

SCAI Statement on the BARI 2D Trial (Bypass Angioplasty Revascularization Investigation With Diabetes Trial) Presented at the American Diabetes Association (ADA) Annual Scientific Sessions and Published in The New England Journal of Medicine

...t so low as to induce hypoglycemia, the result may achieve strong positive outcomes. The goal - and challeng... medical guidelines have never suggested PCI could achieve the life-saving benefits for the "healthier" patie...ug interactions is imperative to all physicians to achieve the best possible outcomes for our patients." ...

Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009

...Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) I...at weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii) About BYETTA (R) (exenatide) ...
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