Positive in Medical Technology

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

... Familial Hypercholesterolemia (FH) patients; positive top line data was reported in May 2009 ... refining our regulatory strategy. We reported positive top-line results from a Phase 3 study of ... options. Isis and Genzyme reported positive top-line mipomersen Phase 3 data in patients with ...

University of Michigan Study Shows SEQUENOM's MassARRAY Technology Identifies HPV Infections Missed by Standard Hybridization Test

... negative for high-risk HPV by the HC2 test were positive by PCR-MS, and approximately 15% of these samples ... of 124 cervical scraping samples that were positive by HC2 for high-risk HPV were negative by PCR-MS. ... types included in the HC2 test, reflecting false positive results in the HC2 test. ...

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

... positive Opinion Recommends Approval of New Anti-TNF ... of the European Medicines Agency (EMEA) adopted a positive opinion recommending the approval of SIMPONI(TM) ... active RA, active PsA and active AS. "This positive opinion is an important step toward an approval ...

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

... and UCB (Euronext Brussels: UCB) announced today positive preliminary top-line results from the second of ... the treatment of fibromyalgia. Confirming the positive results from the first Phase III study, this ... at San Antonio. "Sodium oxybate has shown a positive effect on a number of the symptoms of ...

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

... should the new confirmatory Phase 3 study produce positive results, the data would be sufficient to support ... and Canada. "We are very pleased to obtain a positive response from the EMEA regarding the design of ... in clinical trials or due to lack of progress or positive results from research and development efforts, ...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

... Sessions Expand on Previously Announced positive Top-Line Results - NEW ORLEANS, June 6, ... today a late-breaking poster presentation of positive results from BLOOM (Behavioral modification and ... Biomedical Research Center. "Lorcaserin's positive impact on multiple secondary measures has ...

Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

... Pharma Co., Ltd., (DSP) announced today that positive results from a phase 2 clinical trial for ... total score (-14.1 vs. -5.5; p=0.004), PANSS positive subscale (-4.3 vs. -1.7; p=0.006), PANSS negative ... factors. The condition is characterized by positive and negative symptoms, such as hallucinations, ...

Proteolix Presents Positive Clinical Data for Carfilzomib in Multiple Myeloma at the 2009 ASCO Annual Meeting

... (ASCO). In addition, Proteolix presented positive data today from an ongoing Phase 2 clinical trial ... " (Abstract #8504). "We are excited by the positive demonstration of patient benefit achieved in our ... Accelerated Approval Strategy Based on the positive data achieved in this Phase 2 trial, Proteolix ...

FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmab's ARZERRA(TM) (ofatumumab)

... investigational treatment. "The committee's positive vote in support of ofatumumab is a potential ... respond to available therapies. "The positive vote by ODAC confirms that ofatumumab may offer a ... Executive Officer of Genmab. "Today's vote is positive affirmation for this medicine, which is a result ...

New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER-2 Positive Breast Cancer

... with trastuzumab (Herceptin(R), Roche) in HER-2 positive (ErbB-2 positive) breast cancer, and a separate ... with these therapies, is an active agent in HER-2 positive breast cancer," says Ramona Swaby, M.D., ... improvements have been made in treating HER-2 positive breast cancer, there remains an unmet medical ...

Genomic Health Study Shows Breast Cancers in Men Display Very Similar Gene Signatures to Those in Women

... by gender status in estrogen receptor (ER) positive tumor specimens. As with female breast cancer, a ... between the triple negative and hormone receptor positive groups, including genes for which targeted agents ... breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive. For more ...

Lower Extremity Peripheral Vascular Stent and Balloon Catheter Markets to Exceed $180 Million in Europe by 2013

... positive clinical data, competitor focus, and new ... artery disease in Europe is being fueled by positive clinical trial results, increased competitor ... year-over-year growth, driven primarily by positive data released from clinical trials such as ...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

... Sumitomo Pharma Co., Ltd., (DSP) announced today positive results from the first phase 3 clinical trial for ... associated with greater improvement on both the positive and Negative Syndrome Scale (PANSS) total score ... factors. The condition is characterized by positive and negative symptoms, such as hallucinations, ...

Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection

... positive data from subgroup analysis presented at 19th ... ) Dr. Louie presented the positive top-line results that the Company had previously ... of diarrhea associated with CDI confirmed by a positive toxin test. Global cure was defined as patients ...

Quest Diagnostics Introduces First Commercial Laboratory Test for Identifying the H1N1 Swine Flu Virus

... validated using clinical specimens confirmed positive for Influenza A H1N1 Swine-origin flu virus ... to its reference laboratory confirmed as positive for the novel H1N1 influenza virus by public ... required private clinical laboratories to provide positive Influenza virus type ...

BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financial Results

... with acute uncomplicated influenza confirmed by positive rapid antigen test, whose symptom duration was 36 ... Shionogi initiated its Phase 3 study based on positive clinical results from a Phase 2 study that ... preclinical and clinical development may not have positive results; that we or our licensees may not be able ...

AdvanDx Launches Fast, 90 Minutes Protocol for All CE-IVD Marked PNA FISH(R) Tests in Europe

... Identification Results in 90 Minutes Direct from positive Blood Cultures Faster Results to Help ... bacteria and Candida species directly from positive blood cultures Fast and actionable ... of all patients with bloodstream infections and positive blood cultures Cost/Benefit and outcomes ...

DOR BioPharma, Inc. Executes $400,000 Equity Investment Agreement With Numoda Corporation

... in our success enhances the likelihood of a positive outcome. It is gratifying to me that Numoda ... in clinical trials or due to lack of progress or positive results from research and development efforts, ... amount of time and money to complete and positive results leading to regulatory approval cannot be ...

CDC Analysis Finds Unique Social and Behavior Intervention Helps Reduce MRSA Rates Up to 62% in Study Hospitals

... aureus (MRSA) prevention program that employed positive deviance (PD), a novel approach to social and ... In 2006, Plexus, in collaboration with the positive Deviance Initiative and the CDC, began its MRSA ... practices has been combined with the 'how' of positive deviance. The results achieved by the hospitals ...

Shareholder Class Action Filed Against Rigel Pharmaceuticals, Inc. by the Law Firm of Barroway Topaz Kessler Meltzer & Check, LLP

... Company issued a press release which publicized positive results of a clinical trial of R788. The December ... filed that same day. In response to the positive news of the results of the Study, the price of ... Thereafter, defendants continued to tout the positive results of the Phase II clinical trial of R788. ...

Data Suggests New Antigen-Antibody Combo Test Useful for High Volume Public Health Screening

... who subsequently tested HIV antibody positive were tested individually with two different HIV RNA assays. Those determined positive by both methods were classified as acute ... Overall, 328 individuals (2.3 percent) were positive for HIV antibodies, and 36 of those who tested ...

ISTA Pharmaceuticals Announces Positive Results for Phase IIb Study of Ecabet Sodium

... Inc. (Nasdaq: ISTA ), today announced positive results from the Company's Phase IIb clinical ... treated with ecabet sodium achieved a strong positive trend in the objective sign of Tear Film Break-Up Time (TFBUT) and a positive trend in the objective sign of quantity of tears ...

Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches

... with AZ-104 in an in-clinic setting, showing its positive effect treating pain and other key symptoms ... In March 2008, the Company announced positive initial results of an in-clinic, multi-center, ... patients. Alexza has completed and announced positive initial results from both of its AZ-004 Phase 3 ...

AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab(TM) Combination (ARX-03) in Treating Procedural Pain and Anxiety

... emphasis on pain management, today announced positive results from a Phase 1 clinical study evaluating ... to be safe and well tolerated. Based on these positive results, AcelRx intends to further advance ... safer peak plasma levels than IV. "The very positive data generated from this study validates the ...

Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial

... Inc. (Nasdaq: ALXA ) today announced positive results from its second Phase 3 clinical trial of ... than three months, and today we are reporting positive top-line results for the primary and secondary ... "These very strong results -- coupled with the positive data from our first Phase 3 trial in ...

Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)

... (GSK) and Genmab A/S (OMX: GEN) announced today positive results from a pivotal trial pre-planned interim ... respiratory tract infection. No patient tested positive for antibodies to ofatumumab.(1) "There ... to treatment with ofatumumab.(1) "The positive results seen in this interim analysis reinforce ...

CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors

... Schering-Plough Receives CHMP positive Opinion for TEMODAL(R) Intravenous Formulation ... the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of the intravenous ... in the EU. The CHMP also has issued a positive opinion recommending approval of a sachet ...

Cepheid Molecular Diagnostic Test for Positive Blood Culture Bottles Categorized 'Moderate Complexity' by FDA

... aureus (SA), (typically Methicillin-sensitive) in positive patient blood culture bottles. Cleared by the ... BC is the first molecular diagnostic test for positive blood culture bottles to receive the moderate ... now be run 24/7." Xpert MRSA/SA BC processes positive blood culture specimens to determine if a ...

Novexel Reports Positive Phase II Trial Results With NXL103 in Adult Patients With Community Acquired Pneumonia

... global problem of microbial resistance, announces positive results from its Phase II clinical ... has potent in vitro activity against certain Gram positive bacteria including methicillin resistant ... for the treatment of infections caused by Gram positive organisms, including resistant pathogens such as ...

PharmAthene Presents Data for Protexia(R) and Valortim(R) at 2008 BARDA Industry Conference / PHEMCE Stakeholders Workshop

... one intravenous dose of 10 mg/kg Valortim(R) when positive by ECL; a second cohort of 6 AGMs was treated ... of 10 mg/kg Valortim(R) (the first given when positive by ECL and the second dose administered 24 hours ... intravenous dose of 20 mg/kg Valortim(R) when positive by ECL. Results showed that 56% (10 of 18) of ...

Quigley Anti-Viral Compound QR448(a) Successfully Prevents Transmission of Infectious Bronchitis in Chickens

... QGLY ), http://www.quigleyco.com, announced positive results from a follow up study conducted by its ... IBV outbreaks. The Company recently announced positive results of a study to determine the duration of ... plans to continue to build on these recent positive results to improve its potential commercial and ...

Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients

... Inc. (Nasdaq: ALXA ) today announced positive results from its first Phase 3 clinical trial of ... less than four months, and today we are reporting positive top-line results for the primary and secondary ... range of "normal" to "mild calmness". "These positive Phase 3 results, corroborating our Phase 2 ...

Algeta Reports Positive Headline Phase II Data on Pain Palliation With Alpharadin

... metastases." Commenting on today's further positive news with Alpharadin, Algeta's President and CEO, ... view has been reinforced by the enthusiastic and positive response we have received from key ... prostate cancer (ALSYMPCA) based on positive phase II results. Alpharadin is a ...

Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber

... -- - Oralair(R) Grasses 300IR Highly positive Clinical Results in a Pharmacodynamic Study ... Chamber Stallergenes S.A. announces the highly positive results of a new study conducted in an Allergen ... of the German health agency. Based on the positive results of the paediatric pivotal study ...

Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant

... -- Isolagen(TM), Inc. (Amex: ILE) announced today positive top-line efficacy and safety results from ... in the studies. "I am excited by these positive study results suggesting a clinical benefit from ... acne and burns. "We are thrilled with the positive results from our pivotal Phase III clinical ...

New Data Highlight Positive Results of Namenda(R) (memantine HCl) Once-Daily Extended-Release Formulation

... Laboratories, Inc. (NYSE: FRX ) presented today positive Phase III data of a once-daily extended-release ... additional assessment variables reinforced the positive findings seen with the primary ... developing and delivering products that make a positive difference in people's lives. In addition to its ...

BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting

... which enrolled 300 subjects who had a positive rapid antigen test indicating acute influenza ... influenza." "We are encouraged by the positive results of this Phase II study testing a single ... preclinical and clinical development may not have positive results, that we or our licensees may not be able ...

Medivation Announces Publication in The Lancet of Dimebon Pivotal Trial Results in Alzheimer's Disease

... These data, coupled with our recently announced positive results in Huntington's disease, suggest that ... action. On July 7, 2008, Medivation announced positive safety and efficacy results from its Phase 2 ... Huntington's disease based on the positive results seen in its Phase 2 trial. For more ...

Study Shows Use of AdvanDx's PNA FISH(TM) Test was Associated with an 82% Reduction in Intensive Care Unit Mortality Rates from Staphylococcus aureus Bloodstream Infections

... when a culture of a patient's blood turns positive with Gram-positive cocci in clusters (GPCC), ... of S. aureus and CoNS directly from positive blood cultures in hours instead of days. The test ... During the WHC study period, 202 patients with positive blood cultures containing GPCC were enrolled and ...

Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival

... Alexander Eggermont, M.D., Ph.D, was the largest positive adjuvant trial ever conducted in patients with ... nodes. Similarly, the HR in patients with one positive lymph node was 0.71 (99 percent CI, 0.53-0.97, ... CI, 0.73-1.21) in patients with more than one positive lymph node. Peginterferon alfa-2b adjuvant ...