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FDA approves additional intended use of Roche's cobas TaqScreen MPX Test

Roche announced today that the United States Food & Drug Administration (FDA) approved an additional intended use for its licensed nucleic acid test, to screen source plasma in pools comprised of up to 96 individual donations. The test, called the cobas® TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative, in-vitro test for the simultaneous, direct detection of the human immunodeficiency virus (HIV-1 Group M RNA, HIV-1 Group O RNA , HIV-2 RNA), hepatitis C virus RNA and hepatitis B virus DNA in human plasma.

From Roche Sequencing and Life Science 2 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

RSNA: Dec. 2, 2009 briefing and presentations

A special press briefing will be held Wednesday, Dec. 2, at 10:45 a.m. CT (11:45 a.m. ET), featuring a panel of top experts who will discuss the recent U.S. Preventive Services Task Force (USPSTF) release of revised screening mammography guidelines. Many patients, breast cancer survivors, medical experts and government authorities dispute the guidelines as being without scientific evidence.

2 Dec 2009

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Stemline Therapeutics, Inc., a private clinical stage biopharmaceutical company and leading developer of oncology compounds directed to cancer stem cells, today announced that The University of Texas M.D. Anderson Cancer Center (Houston, TX) and Stemline have entered into a research collaboration.

2 Dec 2009

Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard(®) were presented at the American Heart Association (AHA) Scientific Sessions 2009, on Sunday, November 15 in Orlando, Florida.

2 Dec 2009

nContact Surgical initiates clinical trials of its convergent procedure for paroxysmal AF

nContact Surgical, Inc. ("nContact"), a leader in the investigation of devices for minimally-invasive treatment for heart conditions, today announced the initiation of a feasibility clinical trial designed to evaluate the safety and efficacy of a combined surgical and catheter procedure, the convergent procedure, for the treatment of symptomatic paroxysmal atrial fibrillation (AF). This prospective, feasibility study will enroll patients at study sites across the United States.

2 Dec 2009

Harvest Technologies' BMAC System exhibits potential as an effective treatment for CLI

Harvest Technologies Corp. announced today results from the company sponsored 60-patient clinical trial conducted at Sri Ramachandra Medical Center in Chennai, India using the company's BMAC System to treat patients with non-reconstructable Critical Limb Ischemia (CLI). Sri Ramachandra Medical Center is a Harvard Medical international-associated institution based in Chennai, India and one of the largest private healthcare facilities in South Asia.

2 Dec 2009

ImThera Medical implants its aura6000 neurostimulation device in two OSA patients

ImThera Medical, Inc. today announced that two patients have been surgically implanted with ImThera’s aura6000™ neurostimulation device for treating tongue-based Obstructive Sleep Apnea (OSA). Patients are being enrolled in ImThera’s pilot clinical investigation in Belgium with the first results expected to be published in the first half of 2010.

2 Dec 2009

Results from second Phase III placebo controlled study of EXPAREL announced

Pacira Pharmaceuticals, Inc., announced today that its second Phase III placebo controlled study of EXPAREL(TM) (DepoBupivacaine) met its primary endpoint.

2 Dec 2009

DiaMedica to acquire all issued and outstanding shares of Sanomune

DiaMedica Inc. (TSX VENTURE:DMA)("Diamedica"), a biopharmaceutical company that has discovered and is developing a novel approach to treating diabetes, announces it has entered into a non-binding letter of intent to acquire all of the issued and outstanding shares of Sanomune Inc.

2 Dec 2009

Data from brentuximab vedotin and dacetuzumab programs to be presented by Seattle Genetics

Seattle Genetics, Inc. today announced that data from its brentuximab vedotin (SGN-35) and dacetuzumab (SGN-40) programs will be reported at the upcoming 51st American Society of Hematology (ASH) 2009 Meeting and Exposition being held December 5-8, 2009 in New Orleans, Louisiana.

2 Dec 2009

New data on pixantrone Phase III trial in non-Hodgkin's lymphoma to be presented

Cell Therapeutics, Inc. (CTI) announced today that Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial will present new data on the pixantrone phase III trial in relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) at the 51st Annual Meeting of the American Society of Hematology on Saturday, December 5, 2009 in New Orleans, Louisiana.

2 Dec 2009

Results from ongoing clinical trial of ISF35 to be presented at ASH annual meeting

Memgen announced today that results from its ongoing, Leukemia & Lymphoma Society co-sponsored clinical trial in chronic lymphocytic leukemia (CLL) have been selected for an oral presentation at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana.

2 Dec 2009

Annual screening ultrasound may benefit women who are at elevated risk for breast cancer

Results of a large-scale clinical trial presented today at the annual meeting of the Radiological Society of North America (RSNA) provide the first strong evidence of the benefit of annual screening ultrasound for women with dense breasts who are at elevated risk for breast cancer. In addition, the study confirmed that MRI is highly sensitive in depicting early breast cancer.

2 Dec 2009

Ohr Pharmaceutical to present interim data from ongoing Phase II clinical trial of OHR/AVR118

Ohr Pharmaceutical Inc., announced that interim data from the company's ongoing Phase II clinical trial of OHR/AVR118 for the treatment of Cachexia, will be presented at the 5th annual meeting of the Society on Cachexia and Wasting Disorders (SCWD), which will be held in Barcelona December 5 - December 8, 2009.

2 Dec 2009

CRO to run CEL-SCI's upcoming Phase III clinical trial

CEL-SCI Corporation, a late-stage oncology company and a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases, announced today that it has retained the services of an international Contract Research Organization (CRO) to run CEL-SCI's upcoming Phase III clinical trial in advanced primary head and neck cancer with the Company's lead product candidate, Multikine®.

1 Dec 2009

Positive data from Provectus Pharmaceuticals' psoriasis and atopic dermatitis trials

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced preliminary data for the company’s PH-10 Phase 2 clinical trial for Psoriasis as well as for its Phase 2 clinical trial for Atopic Dermatitis.

1 Dec 2009

StemCyte concludes exclusive license and commercialization agreement with Academia Sinica

StemCyte, Inc. concluded an exclusive license and commercialization agreement with Academia Sinica, the National Laboratory of Taiwan, for certain proprietary methods and Intellectual Property (IP) related to the treatment of Chronic Stroke with stem cells.

1 Dec 2009

Clinical trail shows PAD patients also experience asymptomatic heart disease

Results of a randomized, controlled clinical trial presented today at the annual meeting of the Radiological Society of North America (RSNA) reveal that one in five patients with narrowing or blockage in arteries that supply blood to the legs and other parts of the body also have significant but silent coronary artery disease.

1 Dec 2009

Phase 1 study of preventive HIV vaccine testing a novel delivery mechanism completed

A Phase 1 study of a preventive HIV vaccine testing a novel delivery mechanism known as electroporation – the use of electrical pulses to increase the immune responses elicited by DNA vaccines – was recently completed in New York City.

1 Dec 2009

Clinical Trial News and Research

FDA approves additional intended use of Roche's cobas TaqScreen MPX Test

New data demonstrating the strength of Novartis' hematology portfolio to be presented

RSNA: Dec. 2, 2009 briefing and presentations

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

nContact Surgical initiates clinical trials of its convergent procedure for paroxysmal AF

Harvest Technologies' BMAC System exhibits potential as an effective treatment for CLI

ImThera Medical implants its aura6000 neurostimulation device in two OSA patients

Results from second Phase III placebo controlled study of EXPAREL announced

DiaMedica to acquire all issued and outstanding shares of Sanomune

Data from brentuximab vedotin and dacetuzumab programs to be presented by Seattle Genetics

New data on pixantrone Phase III trial in non-Hodgkin's lymphoma to be presented

Results from ongoing clinical trial of ISF35 to be presented at ASH annual meeting

Annual screening ultrasound may benefit women who are at elevated risk for breast cancer

Ohr Pharmaceutical to present interim data from ongoing Phase II clinical trial of OHR/AVR118

CRO to run CEL-SCI's upcoming Phase III clinical trial

Positive data from Provectus Pharmaceuticals' psoriasis and atopic dermatitis trials

StemCyte concludes exclusive license and commercialization agreement with Academia Sinica

Clinical trail shows PAD patients also experience asymptomatic heart disease

Phase 1 study of preventive HIV vaccine testing a novel delivery mechanism completed

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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