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Auxilium, FCB I file suit against Watson over generic Testim

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Gel, 1%. Watson's 1% testosterone gel product is a generic version of Auxilium Pharmaceuticals, Inc.'s Testim 1%.

25 May 2012

LVRC safe and effective choice for patients with severe heterogeneous emphysema

A tiny, resilient metal wire designed to gather and compress diseased lung tissue may offer relief to patients with severe heterogeneous emphysema, a subtype of the disease that involves specific, usually isolated areas of the lungs, according to the results of a multicenter international trial conducted in the Netherlands, Germany and France. The wire, called a lung volume reduction coil (LVRC), can be easily implanted and is designed to take the place of more invasive procedures used to improve the lung function of emphysema patients.

24 May 2012

Positive Results for Pulsar Stent in Clinical Study – BIOTRONIK announces

The six-month results from the prospective, multicenter, single-arm 4EVER study demonstrate efficacy and safety of BIOTRONIK's Pulsar Stent System in 120 superficial femoral artery (SFA) patients. Analysis of the 120 patients showed excellent device performance, very promising patency rates and convincing evidence of the benefits of lower limb intervention on a 4F platform. Although only the interim results were presented at the Leipzig Interventional Course (LINC 2012) in Leipzig, Germany, analysis of the full cohort has recently been made available.

24 May 2012

Optogenetic Therapies for Vision workshop to be held on June 1

The Foundation Fighting Blindness and Massachusetts Eye and Ear will host the Optogenetic Therapies for Vision workshop on Friday, June 1, from 8 a.m.-6 p.m., in Boston.

24 May 2012

Optimi prototype effectively predicts people at risk of depression

The computing tool, developed by researchers at the Universitat Jaume I in Castellón, the Universitat Politècnica of València and the Universitat de València, along with professionals from the company everis, is able to predict if a person with a high-stress level is at risk of becoming depressed, based on the study of a series of physiological and psychological variables in which artificial intelligence techniques are used.

24 May 2012

Tenn. doctors, Blue Cross and Blue Shield agree to bundle payments for knee, hip replacements

In other insurance company news, BlueCross Blue Shield of Illinois will pay $25M to settle coverage denial claims.

24 May 2012

New trauma intervention halves psychological distress in child war and sexual abuse victims

A new psychological intervention has been shown to more than halve the trauma experienced by child victims of war, rape and sexual abuse.

24 May 2012

Chronic diseases, bloodstream infections on the rise among HIV+ ICU patients

The expanded use of antiretrovirals, potent drugs used to treat retroviral infections such as human immunodeficiency virus (HIV), has been linked to significant decreases in hospital mortality rates among severely ill HIV-positive (HIV+) patients nationwide, primarily due to a decrease in opportunistic infections, according to a new study by researchers at Stanford University.

24 May 2012

PTH boosts AMPs to fend off infection-causing microbes

Antimicrobial peptides (AMPs) are molecules produced in the skin to fend off infection-causing microbes. Vitamin D has been credited with a role in their production and in the body's overall immune response, but scientists at the University of California, San Diego School of Medicine say a hormone previously associated only with maintaining calcium homeostasis and bone health is also critical, boosting AMP expression when dietary vitamin D levels are inadequate.

24 May 2012

Preliminary results from Celldex’s CDX-011 Phase 2b breast cancer study

Celldex Therapeutics, Inc. today announced preliminary results from the Company's randomized Phase 2b EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated breast cancer. Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression.

24 May 2012

Nevro to initiate Senza HF-SCS System study for chronic pain

Nevro Corp., a medical device company focused on achieving improved pain relief for patients suffering from debilitating chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro's high-frequency spinal cord stimulation system for the treatment of chronic pain.

24 May 2012

Azithromycin can be effective treatment option for patients with BOS

Researchers in the United Kingdom have determined that azithromycin, a broad-spectrum antibiotic that also has anti-inflammatory properties, can be an effective treatment option for patients suffering from bronchiolitis obliterans syndrome (BOS), a life-threatening complication that occurs in the majority of patients following lung transplantation.

24 May 2012

Molecular Therapy releases characteristics and activity of SNS01 formulation

Senesco Technologies, Inc., announced today that the characteristics and activity of SNS01 have been released on-line in Molecular Therapy, the official journal of the American Society for Gene & Cell Therapy.

24 May 2012

Many women not screened for gonorrhea and chlamydia infection during pregnancy

Many women are not screened for chlamydia and gonorrhea infection during their pregnancy, and follow-up testing is not always performed as medically recommended for those who test positive for chlamydia, according to a study published online in the American Journal of Obstetrics and Gynecology.

From Quest Diagnostics 24 May 2012

Bayer submits regorafenib NDA with FDA for treatment of mCRC

Bayer HealthCare announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer.

24 May 2012

Phase I/II clinical trial of novel dialysate completed by Zytoprotec

Zytoprotec, a company developing drugs based on active cytoprotection, today announced the completion of a Phase I/II clinical trial with its lead product, PD-protec™. The product is developed to improve the treatment of patients with kidney failure.

23 May 2012

Scientists may be step closer to developing new therapy for AML

Scientists at Virginia Commonwealth University Massey Cancer Center may be one step closer to developing a new therapy for acute myeloid leukemia (AML) after discovering that the targeted agents obatoclax and sorafenib kill leukemia cells much more effectively when combined than when the drugs are administered individually.

23 May 2012

Studies examine effectiveness of CPAP in reducing risk of cardiovascular outcomes linked with OSA

Two studies that included adults with obstructive sleep apnea examined the effectiveness of reducing the risk of cardiovascular outcomes, including high blood pressure, by treatment with continuous positive airway pressure (CPAP), according to the articles in the May 23/30 issue of JAMA.

23 May 2012

HeartWare receives expanded European label for Ventricular Assist System

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced that it has received an expanded European label for long-term use of the HeartWare Ventricular Assist System in all patients at risk of death from refractory, end-stage heart failure.

23 May 2012

Study shows how streamlined patient pathways may improve efficiency of healthcare delivery

The Alliance for Home Health Quality and Innovation (the Alliance) today released research detailing the care pathways patients receive for three distinct episode types: post-acute, pre-acute and non-post-acute.

23 May 2012