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Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis, a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung.

31 Aug 2010

Bionovo receives positive guidance for Menerba drug candidate

Bionovo, Inc. announced today that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba.

31 Aug 2010

Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

Johnson & Johnson Pharmaceutical Research & Development, announced today that the investigational, oral anticoagulant rivaroxaban successfully demonstrated non-inferiority compared to the standard of care for the prevention of recurrent venous thromboembolism (VTE) in patients with acute symptomatic deep vein thrombosis (DVT), with a comparable safety profile.

31 Aug 2010

Bioheart's MyoCell adult stem cell therapy shows effective for heart failure patients: Study

Bioheart, Inc., The mission of the Cell Therapy Foundation is to improve public health through the support of effective adult stem cell research and education. The Foundation aims to promote basic and applied knowledge, processes and cell therapies.

31 Aug 2010

OrthoAccel announces full-market release of AcceleDent dental device

OrthoAccel Technologies, Inc. announced this week that following a successful limited market release of AcceleDent last October it will be initiating a full-market release throughout the United Kingdom this coming September. Availability of AcceleDent, which is a regulated medical device and only available to dental professionals to prescribe to their patients, will be featured at the British Orthodontic Conference (BOC) next month in Brighton.

31 Aug 2010

Using clopidogrel, PPIs increases cardiac damage risk: Study

Patients with coronary artery disease undergoing stent implantation are often prescribed the antiplatelet drug, clopidogrel. This drug prevents blood clots, but is known to have a side-effect that can cause stomach bleeding. Consequently, many users are also prescribed a proton pump inhibitor (PPI). Now, however, a meta-analysis of almost 160,000 patients carried out at the Medical University of Vienna and Wilhelminenhospital, Vienna, has shown that simultaneous use of these drugs can increase the risk of cardiac damage.

31 Aug 2010

Amsterdam Molecular first half 2010 net loss in line with last year

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, today reported its results for the first half year of 2010.

31 Aug 2010

SIR issues position statement to determine safety, effectiveness of interventional M.S. treatment

Recognizing that venous interventions may potentially play an important role in treating some patients who suffer from multiple sclerosis an incurable, disabling disease the Society of Interventional Radiology has issued a position statement indicating its support for high quality clinical research to determine the safety and effectiveness of interventional M.S. treatments.

31 Aug 2010

Cannabis Science seeks entry into European medical cannabis market

Cannabis Science Inc., a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to announce that the Company is currently raising working capital in the European market and pursuing listings on the Frankfurt and other major European exchanges.

30 Aug 2010

Otonomy announces closing of $38.5 million Series B financing

Otonomy, Inc. announced today that it has closed a $38.5 million Series B financing co-led by Novo Ventures and RiverVest Venture Partners, and joined by Domain Associates and TPG Biotech. This financing is incremental to the $10 million Series A closed with Avalon Ventures in June 2010. Avalon also participated in the Series B round.

30 Aug 2010

Nanotherapeutics files NanoDTPA IND for treatment of radiation exposure

Nanotherapeutics, Inc., announced that it has filed an Investigational New Drug (IND) Application with the Food and Drug Administration (FDA) for NanoDTPA™ an orally administered capsule that is a less invasive treatment alternative to the FDA approved injectable Zn-DTPA (diethylenetriamine pentacetic acid). DTPA is used to remove radioactive compounds from the body to help eliminate the contamination. The NanoDTPA™ capsule is a unique orally-bioavailable fine particle formulation that allows DTPA to be absorbed into the body from the gastrointestinal tract.

30 Aug 2010

RLY5016 potassium binder helps to regulate hyperkalemia in heart failure patients

Results from a recent phase 2b clinical trial may provide a new approach to managing excess potassium levels in patients with heart failure and heart failure with chronic kidney disease.

30 Aug 2010

Large clinical trial does not confirm benefits of erythropoieitin for first ST-elevation myocardial infarction

Results from the HEBE III study, a prospective, randomised, multicentre trial performed in seven centres in the Netherlands, suggest that the promising effects of erythropoieitin seen in previous smaller studies cannot be confirmed for the improvement of clinical outcome in patients with a first ST-elevation myocardial infarction.

30 Aug 2010

EndoGastric Solutions receives Series F financing to support Natural Orifice Surgery marketplace

EndoGastric Solutions (EGS), the recognized leader in the emerging field of Natural Orifice Surgery (NOS), today announced that Canaan Partners and Radius Ventures co-led a $30 Million Series F financing designed to support the company through profitability.

30 Aug 2010

23rd ECNP Press conference on impact of circadian rhythms on human brain

All humans are synchronised to the rhythmic light-dark changes that occur on a daily basis. Rhythms in physiological and biochemical processes and behavioural patterns persist in the absence of all external 24-hour signals from the physical environment, with a period that is close to 24 hours

30 Aug 2010

KIKA Clinical Solutions releases Veracity 3.10 Clinical Asset Management EDC platform

KIKA™ Clinical Solutions continues to drive EDC technology innovation with Veracity™ 3.10, the latest release of its market-leading, advanced EDC platform. KIKA is the leading provider of advanced EDC solutions for Clinical Asset Management™ for the pharmaceutical, biotechnology and medical device markets.

30 Aug 2010

Researcher develops new plaque brachytherapy technique to treat eye cancer

Rare but devastating, eye cancer can strike anyone at any time and treating it often requires radiation that leaves half of all patients partially blind.But a new technique developed by Scott Oliver, MD, assistant professor at the University of Colorado School of Medicine, may change all that.

30 Aug 2010

Forest Laboratories reveals top-line results from cariprazine Phase II clinical trial for bipolar depression

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of bipolar depression. Cariprazine is currently undergoing Phase III trials for separate indications of schizophrenia and bipolar mania.

30 Aug 2010

Researchers find smoked cannabis reduces chronic neuropathic pain

For people suffering chronic pain, smoked cannabis reduces pain, improves mood and helps sleep, according to new research published in CMAJ.

30 Aug 2010

Victhom second-quarter revenues decrease 94.4% to $27,901

Victhom Human Bionics Inc. today reported its second quarter 2010 financial results.

27 Aug 2010

Clinical Trial News and Research

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Bionovo receives positive guidance for Menerba drug candidate

Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

Bioheart's MyoCell adult stem cell therapy shows effective for heart failure patients: Study

OrthoAccel announces full-market release of AcceleDent dental device

Using clopidogrel, PPIs increases cardiac damage risk: Study

Amsterdam Molecular first half 2010 net loss in line with last year

SIR issues position statement to determine safety, effectiveness of interventional M.S. treatment

Cannabis Science seeks entry into European medical cannabis market

Otonomy announces closing of $38.5 million Series B financing

Nanotherapeutics files NanoDTPA IND for treatment of radiation exposure

RLY5016 potassium binder helps to regulate hyperkalemia in heart failure patients

Large clinical trial does not confirm benefits of erythropoieitin for first ST-elevation myocardial infarction

EndoGastric Solutions receives Series F financing to support Natural Orifice Surgery marketplace

23rd ECNP Press conference on impact of circadian rhythms on human brain

KIKA Clinical Solutions releases Veracity 3.10 Clinical Asset Management EDC platform

Researcher develops new plaque brachytherapy technique to treat eye cancer

Forest Laboratories reveals top-line results from cariprazine Phase II clinical trial for bipolar depression

Researchers find smoked cannabis reduces chronic neuropathic pain

Victhom second-quarter revenues decrease 94.4% to $27,901

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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