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Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

Takeda Canada, Inc. is pleased to announce that ULORIC® (febuxostat), an innovative oral urate-lowering therapy to lower serum uric acid levels in patients with gout is now available in Canada. This medication is the first new treatment option in more than 40 years for the approximately three per cent of Canadians who have hyperuricemia associated with gout.1 ULORIC was discovered by Teijin Pharma Limited of Tokyo and licensed to Takeda for the Canada market.

21 Oct 2010

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

PolyMedix, Inc., a biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has announced plans for a Phase 2 clinical trial of PMX-60056 in interventional cardiology, and the establishment of a focused Heptagonist Clinical Advisory Board (CAB). PMX-60056 is a synthetic small-molecule designed to reverse the anticoagulant activity of heparin and low molecular weight heparins (LMWH).

21 Oct 2010

$OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS$

OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS

Today OptiNose Inc. announced the positive results of a study evaluating the efficacy of fluticasone when delivered by the Company's novel bi-directional technology in patients with refractory chronic rhinosinusitis (CRS). The results of the study have been published in an article in the September issue of Rhinology.

21 Oct 2010

Intercell and Romark announce IC41-nitazoxanide combination clinical trials for HCV

Intercell AG and Romark Laboratories L.C. today announced plans to commence clinical trials of Intercell's investigational therapeutic Hepatitis C virus (HCV) vaccine, IC41, in combination with Romark's antiviral drug, nitazoxanide, during the first half of 2011.

21 Oct 2010

European FP7 research project to develop environment-friendly pest control products

Tecnalia, through its Construction Unit, is participating in and coordinating a European FP7 research project for SMEs, called Bimosyn. The aim is to develop pest control products with lower concentrations of biocides and, thereby, be more environmentally friendly and less damaging for human health.

21 Oct 2010

Study investigates efficacy of blood analysis with cognitive testing for early diagnosis of AD

One key problem with treating people with Alzheimer's disease (AD) is the fact that it is often very difficult to detect the disease when it is in the early stages of progression. A team of researchers from the University of the West of England are about to embark on a preliminary study to investigate the efficacy of combining biomarkers in blood with cognitive testing as a way of screening for AD early on so that appropriate treatments can be offered to patients sooner.

21 Oct 2010

MAP Pharmaceuticals to present nine analyses on LEVADEX for migraine therapy at 2010 EHMTIC congress

MAP Pharmaceuticals, Inc. today announced that the Company will present nine analyses relating to its LEVADEX™ orally inhaled migraine therapy product candidate, including analysis from the FREEDOM-301 Phase 3 trial, at the 2010 European Headache and Migraine Trust International Congress (EHMTIC) in Nice, France.

21 Oct 2010

Metabolon receives patent for biomarkers to determine PPAR-affecting drugs

Metabolon, Inc., leaders in global metabolomics, biomarker discovery and biochemical analysis, announced today the grant of US Patent 7,807,138 entitled "Biomarkers of Metabolic Responses to Hepatic Drugs". The USPTO awarded the patent to Metabolon on October 5, 2010. This is the 13th patent issued to Metabolon and the second in its portfolio of biomarker patents.

21 Oct 2010

Access submits additional patent applications for Cobalamin-mediated oral drug delivery technology

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has submitted additional patent applications, covering its Cobalamin-mediated oral drug delivery technology formulations of many global top-100 injectable drugs, as a result of the growing interest surrounding the company's proprietary oral delivery technology.

21 Oct 2010

Kinemed updates translational biomarkers strategy at 2010 Conference in Boston

Marc K. Hellerstein, M.D., Ph.D. Co-Founder and Chief of SAB, Kinemed, Inc. presented an "Updated Strategy for Using Disease Predictive Translational Biomarkers in the Rapidly Advancing Field of Causal Pathway Measurements" at the 2010 Personalized and Translational Medicine Conference. In Boston, on September 20-21, 2010.

21 Oct 2010

DMC concludes Protege Phase 3 clinical trial for type 1 diabetes lacks efficacy

MacroGenics, Inc. and Eli Lilly and Company today announced that the Protege Data Monitoring Committee (DMC), composed of independent experts in the fields of diabetes and biostatistics, has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab, an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.

21 Oct 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

Alexion announces results of eculizumab two open-label Phase 2 studies for aHUS treatment

Alexion Pharmaceuticals, Inc. today announced that its two open-label Phase 2 studies investigating eculizumab (Soliris) as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS) have met the primary and key secondary endpoints with high clinical and statistical significance, in interim analyses.

21 Oct 2010

Genzyme reports results of Clolar combination Phase 3 trial in adult AML

Genzyme Corporation announced results today from its CLASSIC I phase 3 trial comparing Clolar® (clofarabine) in combination with the chemotherapy agent cytarabine (ara-c) to cytarabine plus placebo in relapsed-refractory adult acute myeloid leukemia (AML).

21 Oct 2010

Envoy expands drug discovery collaboration with The Scripps Research Institute

Envoy Therapeutics, Inc., a recently-formed drug discovery company, today announced that it has expanded its research collaboration with The Scripps Research Institute aimed at identifying new drugs for neurological and psychiatric diseases.

20 Oct 2010

Abbott third quarter worldwide sales increase 11.8% to $8.7 billion

Abbott today announced financial results for the third quarter ended Sept. 30, 2010.

20 Oct 2010

Rockwell Medical announces design of Phase III development program for Soluble Ferric Pyrophosphate

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron-deficiency anemia, announced today the design of its Phase III development program for Soluble Ferric Pyrophosphate (SFP) as a continuous iron replacement therapeutic.

20 Oct 2010

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

Aradigm Corporation today announced positive top line data from its recently concluded 6-month Phase 2b study (ORBIT-2) with Aradigm's once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis.

20 Oct 2010

NMT releases new device for treatment of post-operative nausea

Neurowave Medical Technologies™ today announced the release of an innovative new device for the treatment of post-operative nausea, medically referred to as emesis. Reletex™ is a novel transdermal neuromodulation device that is non-invasive and drug-free, and has been demonstrated to alleviate nausea when used as an adjunct to anti-emetics.

20 Oct 2010

Efficacy News and Research

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS

Intercell and Romark announce IC41-nitazoxanide combination clinical trials for HCV

European FP7 research project to develop environment-friendly pest control products

Study investigates efficacy of blood analysis with cognitive testing for early diagnosis of AD

MAP Pharmaceuticals to present nine analyses on LEVADEX for migraine therapy at 2010 EHMTIC congress

Metabolon receives patent for biomarkers to determine PPAR-affecting drugs

Access submits additional patent applications for Cobalamin-mediated oral drug delivery technology

Kinemed updates translational biomarkers strategy at 2010 Conference in Boston

DMC concludes Protege Phase 3 clinical trial for type 1 diabetes lacks efficacy

FDA issues complete response letter for BYDUREON NDA

Alexion announces results of eculizumab two open-label Phase 2 studies for aHUS treatment

Genzyme reports results of Clolar combination Phase 3 trial in adult AML

Envoy expands drug discovery collaboration with The Scripps Research Institute

Abbott third quarter worldwide sales increase 11.8% to $8.7 billion

Rockwell Medical announces design of Phase III development program for Soluble Ferric Pyrophosphate

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

NMT releases new device for treatment of post-operative nausea

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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