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CleveMed to distribute its products in Europe and Canada following receipt of the CE Mark and CMDCAS

CleveMed recently received ISO 13485 certification issued by BSI Management Systems America Inc., one of the foremost auditing bodies in the world. CleveMed has also received the CE Mark and CMDCAS allowing its products to be distributed to the large European and the Canadian markets which will strengthen its worldwide market presence.

19 Nov 2009

MONITORING FORCE files for Flibanserin orphan drug status designation with the EMEA

MONITORING FORCE GmbH announced that they have filed on November 16th, 2009 Flibanserin in the indication treatment-relevant levodopa-induced dyskinesia in Parkinson's disease for orphan drug status designation with the European Medicines Agency (EMEA). Levodopa-induced dyskinesia is a complication of the mainstay treatment in advanced Parkinson's and a serious burden to some of those affected, since it may be disabling for the patients and preventing them from receiving optimal treatment for Parkinson's.

19 Nov 2009

Advanced Cell Technology files an IND with the FDA for study using embryonic stem cells to treat SMD

Advanced Cell Technology, Inc. announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD). Among the most common causes of untreatable blindness in the world are degenerative diseases of the retina.

19 Nov 2009

Aegera Therapeutics commences AEG35156 Phase 2B study for AML

Aegera Therapeutics Inc. announced today the dosing of the first patient in a randomized Phase 2B study of AEG35156, a targeted antisense therapeutic in mid-stage development for multiple oncology indications.

19 Nov 2009

VisEn Medical launches two new agents for imaging quantification

VisEn Medical Inc., a leader in fluorescence in vivo imaging from research through medicine, announced today the commercial launch of its new OsteoSense® 800 imaging agent for targeting areas of bone turnover and microcalcification in vivo. The new 800 nm OsteoSense agent complements VisEn's OsteoSense 680 and 750 products, and is expected to further expand the utilization of this agent family in enabling in vivo detection, measurement and monitoring of skeletal changes in a wide range of disease states, including arthritis, osteoporosis, and cancer metastasis.

19 Nov 2009

Positive results from Echo Therapeutics' Symphony tCGM System study

Echo Therapeutics, Inc., a company developing its needle-free Symphony(TM) tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude(TM) SkinPrep System for transdermal drug delivery, today announced positive results of a clinical study of its Symphony tCGM System in patients with Type 1 and Type 2 Diabetes.

19 Nov 2009

Cardiovascular Systems commences patient enrollment in CALCIUM 360° clinical trial

Cardiovascular Systems, Inc., announces the first patient enrollment in its prospective, randomized CALCIUM 360° clinical trial, part of the company’s 360° Clinical Series. The CALCIUM 360° study will evaluate the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI’s Diamondback 360® PAD System, a minimally invasive catheter for treating PAD anywhere in the leg.

19 Nov 2009

Altair Therapeutics initiates its IL-4 receptor alpha inhibitor bronchoprovocation phase 2 trial

Altair Therapeutics, Inc., a privately-held, biopharmaceutical company developing novel therapeutics for respiratory diseases, today announced the commencement of its IL-4 receptor alpha inhibitor bronchoprovocation trial. Study AIR645-CS2 is a phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of inhaled AIR645 in suppressing the asthmatic response in subjects with mild asthma. Results are expected in the third quarter of 2010.

19 Nov 2009

Interim data from Geron's ongoing imetelstat trial presented at the AACR-NCI-EORTC conference

Geron Corporation today announced the presentation of interim data from its ongoing trial of imetelstat (GRN163L), a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

19 Nov 2009

PA: First in nation to release statewide data on autism

Pennsylvania is expected to see a continued rise in the number of children and adults living with autism, according to the Pennsylvania Autism Census Project Final Report released today by Governor Edward G. Rendell.

19 Nov 2009

Embryonic stem cells raise hope of cellular replacement therapy for liver failure

Embryonic stem (ES) cells, known for their capacity to proliferate indefinitely and differentiate into almost all types of cells including hepatocytes, have raised the hope of cellular replacement therapy for liver failure. There have been several protocols available for hepatic fate specification from ES cells, however, most of the protocols currently used result in low yield or purity of functional hepatocytes. Valproic acid (VPA), a histone deacetylase inhibitor, has been demonstrated to facilitate the hepatic differentiation of mesenchymal stem cells. However, little is know about whether VPA could induce the hepatic differentiation of ES cells.

19 Nov 2009

EIN News launches "Mesothelioma News Today"

EIN News, an online leader in industry news monitoring and press syndication, has today added a new publication to its portfolio of health-related international news sites for industry professionals and analysts: Mesothelioma News Today (http://mesothelioma.einnews.com).

19 Nov 2009

IASLC staging classification: A new approach to evaluate and treat lung cancers

The International Association for the Study of Lung Cancer (IASLC) will hold an expert roundtable and Web cast announcing the recent publication and impact of the IASLC's Staging Manual in Thoracic Oncology containing the recently released 7th Edition of TNM in Lung and Pleural Tumours.

19 Nov 2009

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

19 Nov 2009

Updated clinical guidelines on Effient treatment for ACS patients

Effient® (prasugrel) tablets, a new antiplatelet medicine, was added as a treatment option in two clinical guideline updates: one for patients receiving percutaneous coronary intervention (PCI) and a second one for patients with ST elevation myocardial infarction (STEMI), or severe heart attack.

19 Nov 2009

Treatment of iron deficiency can improve symptoms and quality of life in CHF patients

Intravenous (I.V.) iron treatment with ferric carboxymaltose to reverse iron deficiency can significantly improve symptoms, exercise tolerance and quality of life for chronic heart failure (CHF) patients, researchers said in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

19 Nov 2009

Continuous flow heart pump improves survival rates in heart failure patients than current pulsating models

A new, continuous flow heart pump, or left ventricular assist device (LVAD), delivered better two-year survival in advanced heart failure patients than the current pulsatile model, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

19 Nov 2009

OA panel develops a consensus of the optimal exogenous HA treatment using BioRestorative Profiling

A panel of osteoarthritis (OA) key opinion leaders has developed a consensus of the optimal exogenous hyaluronic acid (HA) treatment. This consensus was achieved by utilizing what the experts referred to as BioRestorative(TM) Profiling. This profiling examines HAs on the basis of their mimicking the body's natural HA.

19 Nov 2009

UCLA study: Structural changes in brain may help offset vision loss and strengthen other senses

Visually impaired people appear to be fearless, navigating busy sidewalks and crosswalks, safely finding their way using nothing more than a cane as a guide. The reason they can do this, researchers suggest, is that in at least some circumstances, blindness can heighten other senses, helping individuals adapt.

19 Nov 2009

Microarray analysis can identify chromosome abnormalities in children with Pitt-Hopkins syndrome

Researchers at Signature Genomic Laboratories, which performs diagnostic genetic testing of chromosome abnormalities in individuals with unexplained physical and developmental disabilities, recently showed that microarray analysis can identify small DNA alterations in individuals with Pitt-Hopkins syndrome, a rare and poorly characterized genetic disorder.

19 Nov 2009

Medical Condition News

CleveMed to distribute its products in Europe and Canada following receipt of the CE Mark and CMDCAS

MONITORING FORCE files for Flibanserin orphan drug status designation with the EMEA

Advanced Cell Technology files an IND with the FDA for study using embryonic stem cells to treat SMD

Aegera Therapeutics commences AEG35156 Phase 2B study for AML

VisEn Medical launches two new agents for imaging quantification

Positive results from Echo Therapeutics' Symphony tCGM System study

Cardiovascular Systems commences patient enrollment in CALCIUM 360° clinical trial

Altair Therapeutics initiates its IL-4 receptor alpha inhibitor bronchoprovocation phase 2 trial

Interim data from Geron's ongoing imetelstat trial presented at the AACR-NCI-EORTC conference

PA: First in nation to release statewide data on autism

Embryonic stem cells raise hope of cellular replacement therapy for liver failure

EIN News launches "Mesothelioma News Today"

IASLC staging classification: A new approach to evaluate and treat lung cancers

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Updated clinical guidelines on Effient treatment for ACS patients

Treatment of iron deficiency can improve symptoms and quality of life in CHF patients

Continuous flow heart pump improves survival rates in heart failure patients than current pulsating models

OA panel develops a consensus of the optimal exogenous HA treatment using BioRestorative Profiling

UCLA study: Structural changes in brain may help offset vision loss and strengthen other senses

Microarray analysis can identify chromosome abnormalities in children with Pitt-Hopkins syndrome

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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