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Roche files TnT-hs assay 510(k) submission with FDA for use on laboratory analyzers

Roche announced today that it has filed a 510(k) submission to the U.S. Food and Drug Administration (FDA) for a fully automated TnT-hs assay for use on Roche's full portfolio of laboratory analyzers.

From Roche Sequencing and Life Science 8 Jun 2012

Scientists discover new function for thrombospondin protein

Scientists have discovered a new function for a protein that protects cells during injury and could eventually translate into treatment for conditions ranging from cardiovascular disease to Alzheimer's.

8 Jun 2012

Ocular pulse amplitude reliable, safe screening test for carotid artery stenosis

A simple eye test may someday offer an effective way to identify patients who are at high risk for stroke, say researchers at the University of Zurich. They showed that a test called ocular pulse amplitude (OPA) can reliably detect carotid artery stenosis (CAS), a condition that clogs or blocks the arteries that feed the front part of the brain.

8 Jun 2012

MGH, HSG to conduct PBT2 clinical trial in Huntington's disease

The Huntington Study Group (HSG), under the leadership of Ray Dorsey, M.D. with Johns Hopkins Medical and Diana Rosas, M.D. with Massachusetts General Hospital, is conducting a clinical trial in Huntington's disease (HD) throughout the United States and Australia, "A randomized, double-blind, placebo-controlled, study to assess the safety and tolerability, and efficacy of PBT2 in patients with early to mid-stage Huntington's disease" comparing a 100 mg dose or 250 mg dose versus placebo.

8 Jun 2012

Food allergies more prevalent among urban children

Children living in urban centers have a much higher prevalence of food allergies than those living in rural areas, according to a new study, which is the first to map children's food allergies by geographical location in the United States. In particular, kids in big cities are more than twice as likely to have peanut and shellfish allergies compared to rural communities.

8 Jun 2012

Anti-TNFs increase risk of shingles in patients with inflammatory rheumatic diseases

Patients with inflammatory rheumatic diseases (IRD) treated with anti-tumour necrosis factor medications (anti-TNFs) have a 75% greater risk of developing herpes zoster, or shingles, than patients treated with traditional disease modifying anti-rheumatic drugs (DMARDs), according to a meta-analysis presented today at EULAR 2012, the Annual Congress of the European League Against Rheumatism.

8 Jun 2012

Successful pregnancies common for female liver transplant recipients

New research confirms that successful pregnancies are common for female liver transplant recipients. The study appearing in the June issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases, found miscarriage risk was lower and the live birth rate higher among women following liver transplantation than in the general U.S. population.

7 Jun 2012

BRF to fund research that focuses on sports-related concussive injuries among young children

The Brain Research Foundation (BRF) today announced it will fund research that aims to improve pediatricians' ability to evaluate and manage sports-related concussive injuries among young children, and guide future research regarding the diagnosis, treatment and long term effects of these events.

7 Jun 2012

CardioKinetix commences Parachute Ventricular Partitioning Device clinical trial in IHF

CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that it has begun enrollment in PARACHUTE III, a post-market safety surveillance trial, in Germany with the CE Marked Parachute Ventricular Partitioning Device.

7 Jun 2012

Novartis, Foundation Medicine announce new agreement to offer genomic analysis

Foundation Medicine today announced a new agreement with Novartis to provide comprehensive genomic analysis in support of Novartis' clinical oncology programs.

7 Jun 2012

Initial HSCT results from phase III trial on systemic sclerosis

Initial results from an international, investigator-initiated, open label phase III trial were presented at EULAR 2012, the Annual Congress of the European League Against Rheumatism. Data indicate that haematopoietic stem cell transplantation (HSCT) results in better long term survival than conventional treatment for patients with poor prognosis early diffuse cutaneous systemic sclerosis.

7 Jun 2012

FDA approves XenoPort, GSK’s Horizant ER tablets for management of PHN

GlaxoSmithKline plc (GSK) and XenoPort, Inc. announced today that the United States (US) Food and Drug Administration (FDA) has approved Horizant (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults.

7 Jun 2012

Enrollment complete in Advaxis’ ADXS-HPV Phase 2 study on CIN 2/3

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced today that it has completed enrollment of 40 patients in the second of three dose cohorts in Lm-LLO-E7-07, a randomized, single blind, placebo controlled Phase 2 dose escalation study assessing the safety and efficacy of ADXS-HPV for the treatment of cervical intraepithelial neoplasia (CIN) 2/3.

7 Jun 2012

CDI introduces MyCell Services

Cellular Dynamics International, Inc. (CDI), the world's largest commercial producer of human induced pluripotent stem (iPS) cell lines and tissue cells, today announced the launch of its MyCell Services.

7 Jun 2012

Clinical study shows positive effects of CAD106 vaccine against AD

A study led by Karolinska Institutet in Sweden reports for the first time the positive effects of an active vaccine against Alzheimer's disease. The new vaccine, CAD106, can prove a breakthrough in the search for a cure for this seriously debilitating dementia disease. The study is published in the distinguished scientific journal Lancet Neurology.

7 Jun 2012

Neurotech’s ADNS-300 system obtains European CE Mark approval

Neurotech s.a., a Belgium based developer and manufacturer of neurostimulation devices, announces that it has obtained the European CE Mark for its ADNS-300 system dedicated to the treatment of refractory epilepsy.

7 Jun 2012

Biologic treatments reduce mortality risk in patients with rheumatoid arthritis

According to a study presented today at EULAR 2012, the Annual Congress of the European League Against Rheumatism, patients with rheumatoid arthritis (RA) who are prescribed biologic treatments have a significantly lower mortality risk (adjusted hazard ratio [HR]: 0.61) than those just treated with traditional disease modifying anti-rheumatic drugs (DMARDs).The study also found the mortality was similar irrespective of the method of action of biologics (anti-tumour necrosis factor drugs [anti-TNFs] or rituximab).

7 Jun 2012

Disney to ban junk food ads in obesity fight

The change from the children's entertainment company got a prominent backer Tuesday as First Lady Michelle Obama offered her praise for the move.

7 Jun 2012

Young adults, adolescents with mental health disorders more likely to become long-term opioid users

Long-term use and abuse of opioid painkillers, such as OxyContin and Vicodin, has markedly increased in the United States in the last two decades. Of note, prescription opioids constitute 86.9 percent of prescription drug misuse among high school students. And last week in a two-day U.S. Food and Drug Administration public meeting, officials questioned the use of long-term opioids for chronic pain due to a lack of evidence for the effectiveness and concerns about the potential risk for addiction.

7 Jun 2012

Clinical study demonstrates effectiveness of vismodegib in treating BCNS

A revolutionary clinical study has demonstrated the effectiveness of a new drug, vismodegib, in dramatically shrinking and preventing the formation of basal cell skin cancers - the most common cancer in the United States - in patients with basal cell nevus syndrome (BCNS), a rare genetic condition that causes hundreds to thousands of skin cancers primarily treated by surgical removal.

7 Jun 2012