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InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... a statistically significant effect on both the primary endpoint of change in percent predicted FVC at ... 1 did not achieve statistical significance on the primary endpoint at Week 72, the results were generally ... failed to achieve statistical significance on the primary endpoint in one of its two pivotal clinical ...

SENOMYX ANNOUNCES CORPORATE UPDATE AND SECOND QUARTER 2009 FINANCIAL RESULTS

... and Chief Executive Officer of Senomyx. "Our primary business goal is to maximize the revenue ... Updates: - Savory Enhancer Program: The primary applications of the Company's savory flavor ... year. - Sweet Enhancer Program: The primary goal for this program is to identify flavor ...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

... disorders such as scleroderma, Sjogren syndrome, primary biliary cirrhosis, wasting syndrome, ... did not achieve statistical significance in the primary endpoint of its pivotal trial, namely median ... seek to enroll an estimated 166 patients. The primary endpoint is the treatment failure rate at Study ...

Purdue Pharmaceutical Products L.P. and Transcept Pharmaceuticals, Inc. Sign Exclusive Agreement to Commercialize Intermezzo(R) in the United States

... Transcept. Purdue has an established and growing primary care marketing and sales capability that we ... distributors, managed care organizations and primary care physicians. We believe that Intermezzo ... partner that will make a significant U.S. primary care sales and marketing investment. Our ...

SAPHRIS(R) (asenapine) Meets Primary Endpoint in Long-Term Extension Study in Patients With Predominant, Persistent Negative Symptoms of Schizophrenia

... agent SAPHRIS(R) (asenapine) met the primary endpoint over one year of treatment in an ... to Day 365 in the NSA-16 total score, the primary endpoint of the study. By using a mixed model ... study baseline after one year of treatment, the primary prespecified endpoint of the extension study. A ...

Oncolytics Biotech(R) Inc. Research Collaborators Present Glioma Reovirus Research at ASV Annual Meeting

... with Temozolomide and Low Dose Irradiation in primary Patient Glioma Xenografts Resistant to Treatment ... (TMZ). A panel of glioma cell lines and primary patient glioma explant cells were tested for ... analyses revealed moderate to strong synergy in primary patient glioma cells treated with reovirus plus ...

Study on keeping nuclear bombs from US ports shows misplaced fear over cargo scanning cost

... protocol that emphasizes screening (a rapid primary scan of all containers, followed by a more ... scan of only a few containers that fail the primary test) holds promise as a feasible solution for ... container traffic at a terminal (for the initial primary scan) under the SFI-variant. Implementing their ...

Schering-Plough Announces Phase II and III Data for Corifollitropin Alfa

... ever performed. The ongoing pregnancy rate, the primary endpoint of the ENGAGE non-inferiority trial, ... by human chorionic gonadotropin (hCG). The primary endpoint was the ongoing pregnancy rate assessed ... a maximum of two embryos were transferred. The primary endpoint of the ENSURE trial was the number of ...

OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer

... reviewed Phase 3 trial featuring survival as the primary endpoint. The study population has been modified ... or docetaxel/prednisone alone. The primary endpoint of the study will be overall survival. ... trial design investigates overall survival as the primary endpoint in patients treated with first-line ...

Healthy Advice Networks Announces Improved Patient Outcomes in Physicians' Offices with Healthy Advice Programs

... in the industry and is planning to launch another primary care network, as well as several new programs ... company delivers patient-education programs in primary care, cardiology, women's health, pediatric, ... when and where they need it. Over 50,000 primary care and specialty physicians throughout the U.S. ...

Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA(TM) (Formerly LymphoStat-B(R)) in Patients With Active Systemic Lupus Erythematosus

... 46% to 57% in the response rate selected as the primary efficacy endpoint of the Phase 3 trials (defined ... the Phase 2 Study of BENLYSTA in SLE The primary objectives of the Phase 2 study were to evaluate ... Global Assessment. This response rate is the primary efficacy endpoint in the ongoing pivotal Phase 3 ...

Peregrine Pharmaceuticals Presents Promising Data From Its Phase II Bavituximab Breast Cancer Trial at 2009 ASCO Annual Meeting

... - Interim primary Endpoint Data from Phase II Study Shows 71% ... II breast cancer study later this year." The primary objective of this multi-center, open-label Phase ... cancer patients and it exceeded the pre-specified primary endpoint needed to expand the trial. An ...

Laboratory Test May Predict Effectiveness of ERBITUX(R) for Individual Colorectal Cancer Patients

... Results from the study show that of the 54 primary colorectal cultures tested, eight percent were ... assay was also performed on 54 cultures of primary human colorectal cancer. Cell lines and specimens ... to cetuximab. Dose-response curves of the 54 primary colorectal cultures revealed that eight (8) ...

Cimzia(R) (certolizumab pegol) Provides Long-Term Remission and Response Rates in Infliximab-Refractory Crohn's Patients

... difficult to treat patient population." The primary objective of WELCOME is to assess the clinical ... response and/or tolerance to infliximab. primary efficacy was defined as at least 100 points ... of Cimzia(R) every 2 or 4 weeks from Week 6). The primary endpoint was defined as the rate of response ...

OncoGenex Pharmaceuticals Announces OGX-011 Treatment Provides Survival Benefit in Randomized Phase 2 Trial in Advanced Metastatic Prostate Cancer

... after receiving ten 3-week cycles of therapy. The primary endpoint of the trial was to achieve a 50% ... - The OGX-011 plus docetaxel arm met the primary endpoint of the trial given that 58% of ... trial design investigates overall survival as the primary endpoint; the other trial design investigates ...

InspireMD Announce the Completion of Enrollment for the MAGICAL Trial (MGuard(TM) in Acute Myocardial Infarction) at EuroPCR '09. Results Will be Presented May 21st by Dr. Dariusz Dudek at the InspireMD Cocktail Reception Debate Chaired by Prof. Martin Le

... and performance of MGuard when used during primary PCI in STEMI patients. The MAGICAL trial ... Dudek, Jagiellonian University, Krakow, Poland). primary end-points are incidence of complete ST ... in Krakow. "From the data collected so far, primary PCI for STEMI patients using MGuardTM seems ...

SYNTAX substudy shows positive outcomes for left main patients treated with TAXUS(R) Express(2)(R) Stent System

... this high-risk population; it includes separate primary endpoints for each treatment arm. For PCI patients, the primary endpoint is the rate of long-term patency ... the treated lesion sites. For CABG patients, the primary endpoint is the ratio of obstructed/occluded ...

Healthy Advice Networks Achieves Strong Growth Despite Challenging Economy

... 21% year-over-year revenue growth. Their two primary care programs (a digital screen waiting room ... in the industry and is planning to launch another primary care network, as well as several new programs ... company delivers patient-education programs in primary Care, Cardiology, Women's Health, Pediatric, ...

SENOMYX ANNOUNCES FIRST QUARTER 2009 FINANCIAL RESULTS

... Updates: - Savory Enhancer Program: The primary applications of the Company's savory flavor ... this year. - Sweet Enhancer Program: The primary goal for this program is to identify flavor ... the year. - Bitter Blocker Program: The primary goals of this program are to reduce or block ...

University of Illinois Medical Center in Chicago First Hospital to Install Innovative Shape-HF™ Cardiopulmonary Testing System

... -- The University of Illinois Medical Center, the primary teaching facility for the UIC College of Medicine ... includes a 507-bed hospital and more than 40 primary care and specialty outpatient clinics. It is ... health sciences. The hospital serves as the primary teaching facility for the UIC College of ...

Amylin Pharmaceuticals Announces a New Sales Approach to Better Target the Diabetes Market

... within the diabetes market. Amylin's existing primary care and specialty sales forces will merge into a ... approach to endocrinologists and diabetes-focused primary care physicians. The changes are expected to be ... their efforts within the endocrinology and larger primary care prescriber market to support BYETTA(R) ...

InterMune Reports First Quarter 2009 Financial Results and Business Highlights

... named CAPACITY 1 and CAPACITY 2. The primary endpoint of change in percent predicted Forced ... Survival (p=0.023). The primary endpoint was not met in CAPACITY 1 (p=0.501), but ... failed to achieve statistical significance on the primary endpoint in one of its two pivotal clinical ...

Human Genome Sciences Announces First Quarter 2009 Financial Results and Key Developments

... that Albuferon (albinterferon alfa-2b) met its primary endpoint of non-inferiority to Pegasys ... As previously reported, Albuferon also met its primary endpoint in ACHIEVE 2/3, which was conducted in ... anthrax and cancer. The Company's primary focus is rapid progress toward the ...

OncoGenex Receives Confirmation from FDA on the Design of a Second Phase 3 Trial Evaluating OGX-011 for the Treatment of Advanced Prostate Cancer

... confirms durable pain palliation as an acceptable primary endpoint for a regulatory submission in ... 3 trial featuring durable pain palliation as the primary endpoint adequately addresses the objectives ... trial design evaluates reduction in pain as the primary endpoint. Having evaluated both of these ...

QIAGEN and Chittaranjan National Cancer Institute Partner to Establish First Large-Scale Cervical Cancer Screening Program in Kolkata

... tests for the human papillomavirus (HPV) -- the primary cause of cervical cancer. CNCI will conduct the ... Despite being a preventable cancer with a known primary cause, cervical cancer claims nearly 300,000 ... types of human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more ...

Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)

... first 167 patients enrolled. Also included in the primary analysis are data on 24 small BSA (body surface ... analysis conducted at the end of 2008 for the primary endpoint demonstrated statistically significant ... once we have complete two-year data on the primary patient cohort," said Gary F. Burbach, president ...

PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study

... - Study Meets primary Endpoint Showing Statistically Significant ... in men with advanced prostate cancer met its primary endpoint of improving overall survival compared ... clinical trials, and overall survival was the primary endpoint of the IMPACT trial. The positive ...

Celsis Introduces ReACT(TM) RNA-Based Microbial Detection Assays

... using Celsis Rapid Detection systems for their primary screening of raw materials, in-process and ... will be able to use Celsis ReACT following the primary Celsis AKuScreen(TM) assay, which definitively ... 3-5 days for microbial limits testing. The same primary system has also been proven successful in ...

OncoGenex Reports Financial Results for Fourth Quarter and Fiscal Year 2008 and Provides Outlook for 2009

... such endpoints are the only critical and relevant primary endpoints for Phase 3 trials in patients with ... trial featuring overall survival as the primary endpoint for OGX-011 in combination with ... an SPA featuring pain palliation as the primary endpoint. Other Pipeline Highlights - ...

Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia

... 'Trial Meets primary and Key Secondary Endpoints' NEW YORK, March ... polysomnography (PSG), meeting the prespecified primary and key secondary endpoints of the trial. ... (N=19) confirmed these results, meeting the primary and key secondary endpoints of the trial, and ...

InterMune Reports Fourth Quarter and Full Year 2008 Financial Results and Business Highlights

... named CAPACITY 1 and CAPACITY 2. - The primary endpoint of change in percent predicted Forced ... Survival (p=0.023). - The primary endpoint was not met in CAPACITY 1 (p=0.501), ... failed to achieve statistical significance on the primary endpoint in one of its two pivotal clinical ...

SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS

... Updates: * Savory Enhancer Program: The primary applications of the Company's savory flavor ... year. * Sweet Enhancer Program: The primary goal for this program is to identify flavor ... samples. * Bitter Blocker Program: The primary goals of this program are to reduce or block ...

OncoGenex Provides Update on Two-Year Survival Data from Ongoing Phase 1/2 Clinical Trial of OGX-011 in Non-Small Cell Lung Cancer

... or unspecified non-small cell lung cancer. The primary objectives of the study were designed to estimate ... investigating overall survival as the primary endpoint via the Special Protocol Assessment ... that durable pain palliation is an acceptable primary endpoint for a registration trial in metastatic ...

InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF

... - CAPACITY 2 Meets primary and Key Secondary Endpoints - - CAPACITY 1 Misses primary Endpoint, Provides Supportive Data - - ... idiopathic pulmonary fibrosis (IPF). The primary endpoint of change in percent predicted Forced ...

Sangamo BioSciences Initiates Phase 1 Trial of CCR5-ZFP Therapeutic to Treat HIV/AIDS

... interruption (STI) or therapy "break". The primary objective of the study is to evaluate the safety ... of an HIV-resistant population of human primary T-cells by the permanent genetic modification of ... were resistant to infection by HIV. ZFN treated primary CD4 T-cells and transformed CD4 cell lines ...

China-Biotics, Inc. Receives Manufacturing Certificate for New Products

... solutions to consumers. Synbiotics Capsules' primary active ingredients are ... health. Probiotics Gegen Capsules' primary active ingredients are lactobacillus acidophilus ... Probiotics Tremella Polysaccharide Capsules' primary active ingredients are LA-BB and tremella ...

Human Genome Sciences Announces Initiation of Phase 2b Trial of Albuferon(R) Dosed Monthly in Chronic Hepatitis C

... 2008, HGS announced that Albuferon met its primary endpoint of non-inferiority to peginterferon ... duration of treatment will be 24 weeks. The primary efficacy endpoint is sustained virologic response ... serious liver disease, leading to cirrhosis, primary liver cancer and even death. About Human ...

Rosetta Genomics Announces Exclusive Distribution Agreement With Teva Pharmaceutical Industries Ltd.

... mets - This test can accurately identify the primary tumor site in patients presenting with metastatic ... and consequently been labeled Cancer of Unknown primary (CUP). As metastases need to be treated according ... accurate identification of the metastases' primary origin can be critical for determining ...

Video: Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse(TM) -- First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes

... eyelid margins once daily for 16 weeks. The primary efficacy endpoint was overall eyelash prominence ... BOTOX(R) is approved for the treatment of severe primary axillary hyperhidrosis that is inadequately ... and vertical deviation (16.9%). In severe primary axillary hyperhidrosis, the most common side ...

Anesiva Phase 3 Trial of Adlea Meets Primary Endpoint to Significantly Reduce Pain After Total Knee Replacement Surgery

... non-opioid analgesic drug candidate, achieved its primary efficacy endpoint of reducing post-surgical pain ... site immediately prior to wound closure. The primary efficacy endpoint was the area under the curve of ... patients versus placebo, although the primary endpoint, pain at 4 to 32 hours post-surgery, ...
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