Clinical Trial News and Research

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IQWiG calls for mandatory registration and publication of all clinical trial results

Today the Institute for Quality and Efficiency in Health Care (IQWiG) is calling for registration and publication of the results of all clinical trials to be made obligatory.

25 Nov 2009

EMEA grants orphan drug status for LFB Biotechnologies' recombinant anti-CD20 monoclonal antibody

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the EMEA’s Committee for Orphan Medicinal Products (COMP) was handed down on last October 7th.

25 Nov 2009

Incyte enters into collaboration and license agreement with Novartis

Incyte Corporation (NASDAQ: INCY) announced today that it has entered into a collaboration and license agreement with Novartis for two of its investigational hematology-oncology therapies: INCB18424, an oral JAK1/JAK2 inhibitor that is in Phase III development for myelofibrosis, a serious life-threatening neoplastic condition characterized by varying degrees of bone marrow failure, splenic enlargement and debilitating constitutional symptoms, and INCB28060, an oral cMET inhibitor that is about to enter Phase I development as a potential treatment for multiple cancers.

25 Nov 2009

Initiation of Phase II clinical trial to evaluate the efficacy of BN83495 announced

Ipsen today announced the initiation of an international, multi-center, controlled, randomized Phase II clinical trial to evaluate the safety and efficacy of BN83495, its investigational first-in-class steroid sulfatase (STS) inhibitor, in advanced endometrial cancer.

25 Nov 2009

Guardian Technologies' novel imaging analysis technology platforms may help avoid mammography false positives

Guardian Technologies International, Inc. -- A recent U.S. Preventive Services Task Force report suggests that while mammograms save lives, they also lead to unnecessary additional procedures. Experts suggest that the problem with mammography is that improvements are needed to reduce false positives and increase accuracy.

24 Nov 2009

First-quarter fiscal 2010 results announced by China Aoxing Pharmaceutical

China Aoxing Pharmaceutical Company, Inc., a China-based pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced financial and operational results for the three month ended September 30, 2009, or the first quarter of fiscal year 2010.

24 Nov 2009

OmniComm Systems chosen as Beardsworth's preferred EDC provider

OmniComm Systems, Inc., one of the fastest growing companies in the EDC marketplace, today announced that Beardsworth, a full service contract research organization (CRO) who specializes in difficult therapeutic areas, has selected OmniComm's TrialMaster EDC solution for conducting a Phase II vaccine study.

24 Nov 2009

CytRx to initiate a multinational Phase 2 clinical trial of its doxorubicin prodrug

CytRx Corporation, a biopharmaceutical company, today announced plans to initiate a multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation. Soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body.

24 Nov 2009

Fourth-quarter and full year fiscal 2009 results announced by AVANIR Pharmaceuticals

AVANIR Pharmaceuticals, Inc. today reported unaudited financial results for the three and twelve months ended September 30, 2009.

24 Nov 2009

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

Evidence of cardiovascular risks associated with taking Vioxx, the popular, nonsteroidal anti-inflammatory drug (rofecoxib), could have been identified nearly four years before its manufacturer, Merck & Co. Inc., voluntarily pulled the drug from the market.

24 Nov 2009

StemCells commences patient recruitment for a Phase I clinical trial of HuCNS-SC in PMD

StemCells, Inc. announced today that it has commenced patient recruitment for a Phase I clinical trial designed to test the safety and preliminary efficacy of its HuCNS-SC® purified human neural stem cells in Pelizaeus-Merzbacher Disease (PMD), a neurological disorder that primarily afflicts children. The study is being conducted at the University of California, San Francisco (UCSF) Children’s Hospital, one of the leading medical centers in the United States for neonatology, pediatric neurology and neurosurgery.

24 Nov 2009

New data indicates early association between anti-inflammatory medication and cardiovascular risk

Clinical trial data indicated an association between the anti-inflammatory medication rofecoxib and cardiovascular risk as early as December 2000, before the product was taken off the market in September 2004, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

24 Nov 2009

Team-based care and medical homes may improve chronic disease management

Patients whose hypertension is managed by a physician-pharmacist team have lower blood pressure levels and are more likely to reach goals for blood pressure control than those treated without this collaborative approach, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

24 Nov 2009

AmKor and Hengdian Group sign license agreement to develop and market new drug candidate in China

AmKor (AmKor Pharma, Inc.) and Hengdian Group (Hengdian Group Ltd) today announced the signing of licensing agreement for further development and commercialization of Neu2000 in China.

24 Nov 2009

JDRF partners with the Canadian Government in diabetes research

Juvenile Diabetes Research Foundation (JDRF) Canada is pleased to announce its first partnership with the Government of Canada through the Federal Economic Development Agency of Southern Ontario. Through this innovative two-year partnership, the Government of Canada is committing $20 million and JDRF is making a matching contribution of $10 million to accelerate world-class diabetes research in Southern Ontario by implementing a clinical trial network for diabetes research.

23 Nov 2009

GI Dynamics to present interim data on its EndoBarrier Gastrointestinal Liner study

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced that interim data from its ongoing clinical study of the EndoBarrier™ Gastrointestinal Liner in obese patients with type 2 diabetes will be presented by Eduardo G. Moura, M.D., Ph.D., director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo, on Monday, November 23, 2009 at GASTRO 2009.

23 Nov 2009

FDA grants Fast Track designation for ARCA biopharma's Gencaro

ARCA biopharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of GencaroTM, the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.

23 Nov 2009

Acucela to present data on its ACU-4429 visual cycle modulator for dry AMD

Acucela, a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, announced today that data for the company’s novel visual cycle modulator, ACU-4429, a potential oral treatment for dry age-related macular degeneration (dry AMD), will be featured at the 8th International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) being held in Rome, Italy from December 3 to 6, 2009.

23 Nov 2009

Positive interim results from Nereus Pharmaceuticals' plinabulin VDA study for advanced NSCLC

Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, today announced positive interim results from a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) plinabulin (NPI-2358) in combination with standard chemotherapy (docetaxel) in patients with advanced non-small cell lung cancer (NSCLC).

23 Nov 2009

Phase IIb/III clinical trial results of CINQUIL for pediatric EoE announced

Ception Therapeutics, Inc., a privately held biopharmaceutical company, and Cephalon, Inc. today announced results from a Phase IIb/III clinical trial for CINQUIL(TM) (reslizumab) as a treatment for pediatric eosinophilic esophagitis (EoE). The study was designed to evaluate improvement in the co-primary endpoints of changes in esophageal eosinophil levels and clinical symptoms.

23 Nov 2009

Clinical Trial News and Research

IQWiG calls for mandatory registration and publication of all clinical trial results

EMEA grants orphan drug status for LFB Biotechnologies' recombinant anti-CD20 monoclonal antibody

Incyte enters into collaboration and license agreement with Novartis

Initiation of Phase II clinical trial to evaluate the efficacy of BN83495 announced

Guardian Technologies' novel imaging analysis technology platforms may help avoid mammography false positives

First-quarter fiscal 2010 results announced by China Aoxing Pharmaceutical

OmniComm Systems chosen as Beardsworth's preferred EDC provider

CytRx to initiate a multinational Phase 2 clinical trial of its doxorubicin prodrug

Fourth-quarter and full year fiscal 2009 results announced by AVANIR Pharmaceuticals

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

StemCells commences patient recruitment for a Phase I clinical trial of HuCNS-SC in PMD

New data indicates early association between anti-inflammatory medication and cardiovascular risk

Team-based care and medical homes may improve chronic disease management

AmKor and Hengdian Group sign license agreement to develop and market new drug candidate in China

JDRF partners with the Canadian Government in diabetes research

GI Dynamics to present interim data on its EndoBarrier Gastrointestinal Liner study

FDA grants Fast Track designation for ARCA biopharma's Gencaro

Acucela to present data on its ACU-4429 visual cycle modulator for dry AMD

Positive interim results from Nereus Pharmaceuticals' plinabulin VDA study for advanced NSCLC

Phase IIb/III clinical trial results of CINQUIL for pediatric EoE announced

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