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ArQule announces SPA with FDA for ARQ 197 Phase 3 trial design for NSCLC

ArQule, Inc. today announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of a Phase 3 trial of ARQ 197 in patients with non-small cell lung cancer (NSCLC) of non-squamous histology.

11 Oct 2010

ArQule announces ARQ 197 Phase 2 clinical trial results at ESMO annual meeting

ArQule, Inc. today announced the presentation of final results from a Phase 2 clinical trial in non-small cell lung cancer (NSCLC) of ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, at the annual meeting of the European Society for Medical Oncology (ESMO).

11 Oct 2010

Researchers develop new technique to detect lung cancer

Early detection is critical for improving cancer survival rates. Yet, one of the deadliest cancers in the United States, lung cancer, is notoriously difficult to detect in its early stages.

8 Oct 2010

mtDNA deletion: New biomarker for identifying malignant prostate cancer

Mitomics, world leader in the research and development of mitochondrial genome-based products to improve clinical insight and therapeutic decisions, today announced the publication of new research in the Canadian Urological Association Journal (CUAJ) showing that large-scale deletions in mitochondrial DNA (mtDNA) can indicate cellular changes that are associated with the development of cancer.

5 Oct 2010

Decision Resources: NSCLC drug market to grow from $4 billion in 2009 to over $6.5 billion in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues finds that the non-small-cell lung cancer (NSCLC) drug market will increase from approximately $4 billion in 2009 to more than $6.5 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

4 Oct 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 2010

Orthovita publishes clinical data from IDE pilot studies

Orthovita, Inc., an orthobiologics and biosurgery company, is pleased to announce the publication of "Clinical Experience Using Cortoss for Treating Vertebral Compression Fractures with Vertebroplasty and Kyphoplasty" in the September 15, 2010 edition of Spine.

21 Sep 2010

Blood test developed for non-alcoholic fatty liver disease diagnosis

Scientists at the Basque Center for Cooperative Research in Biosciences (CIC bioGUNE) and OWL Genomics Ltd. (Bilbao, Spain), in collaboration with researchers at the INSERM and University Hospitals (APHP Pitié Salpêtrière Hospital, Pierre & Marie Curie University Paris and Centre Hospitalier Universitaire Nice, University of Nice-Sophia-Antipolis, Nice, France), Vanderbilt University (Nashville, US), the University of Southern California (Los Angeles, US), Clinic Hospital and IDIBAPS (Barcelona, Spain) and the Alcalá de Henares University (Alcalá de Henares, Spain) have used metabolomics technology to develop a blood test for non-alcoholic fatty liver disease (NAFLD) diagnosis.

19 Sep 2010

20-20 Gene Systems launches L-IHC staining for biomarker identification in tumors

20/20 GeneSystems, Inc. announced today at ADAPT 2010, an industry meeting focusing on advancing personalized medicine, the commercial launch of their patented technology for biomarker identification in tumors and other tissue samples. 20/20 is currently offering the technology to industry and academic researchers under service contracts.

15 Sep 2010

Elsevier provides four key electronic textbook titles for UCI School of Medicine

Elsevier, a world-leading publisher of scientific, technical and medical information products and services, announced today it will provide four key electronic textbook titles for UC Irvine School of Medicine's new program that gives Apple iPads to its first-year medical students.

26 Aug 2010

Long-term entecavir therapy suppresses HBV DNA, normalizes ALT and improves liver histology

Researchers from this international study found that patients with chronic hepatitis B virus (HBV) infection who received at least 3 years of cumulative entecavir (antiviral) therapy achieved substantial histologic improvement and regression of fibrosis or cirrhosis. Full details of the study appear in the September issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

18 Aug 2010

Long-term Entecavir therapy reverses fibrosis and cirrhosis in chronic hepatitis B patients

17 Aug 2010

AVEO achieves enrollment target for tivozanib global Phase 3 clinical trial in advanced renal cell carcinoma

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that it has achieved its enrollment target for TIVO-1, its global Phase 3 clinical trial for its oral, triple VEGF receptor inhibitor, tivozanib, in patients with advanced renal cell carcinoma. In February of this year, AVEO initiated enrollment in TIVO-1, and has successfully reached the target enrollment of 500 patients.

12 Aug 2010

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

ArQule, Inc. and Daiichi Sankyo Co., Ltd. today announced that they will move forward with a Phase 3 clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC). In connection with this decision, the sponsor company, Daiichi Sankyo, will file a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo.

3 Aug 2010

ACT responds to FDA queries on Phase I/II study using ES cell derived retinal cells to treat SMD

Advanced Cell Technology, Inc. announced today that it has submitted documentation and a complete response to substantively address the issues raised by the US Food and Drug Administration (FDA) in connection with the Company's plans to initiate a Phase I/II multicenter study using embryonic stem (ES) cell derived retinal cells to treat patients with Stargardt's Macular Dystrophy (SMD).

29 Jul 2010

Allos reports topline results from Phase 2b trial of FOLOTYN vs erlotinib in advanced NSCLC

Allos Therapeutics, Inc. today announced topline results from the Company's randomized Phase 2b investigational trial of FOLOTYN® (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) who had received one or two prior systemic treatments including at least one prior platinum-based regimen. The objective of the trial was to estimate the efficacy of FOLOTYN compared to that of erlotinib as assessed by overall survival.

28 Jul 2010

GE, MSKCC launch colon cancer study

A team of scientists at GE Global Research, the technology development arm for the GE, has launched a study with Memorial Sloan-Kettering Cancer Center, (MSKCC) one of the world's premier cancer centers, to better understand the early stages of colon cancer. The goal is to yield new insights that improve treatment selection and outcomes for cancer patients in the future.

22 Jul 2010

UDCA fails to improve overall histology in NASH patients: Study

A study conducted by researchers at Johann Wolfgang Goethe University in Frankfurt, Germany found that high doses of ursodeoxycholic acid, suggested by some studies to have a beneficial effect on nonalcoholic steatohepatitis, does not improve overall histology in these patients. Full findings of this study are published in the August issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.

21 Jul 2010

T-SPOT.TB test predicts TB infected persons better than TST: Study

The authors of a recent study published in the American Journal of Respiratory and Critical Care Medicine concluded that the T-SPOT.TB test is better than the tuberculin skin test at predicting which patients will develop active TB.

20 Jul 2010

Fibrocell Science completes enrollment in azficel-T histology study

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today the completion of enrollment of and first treatment visits for participants in its histology study (IT-H-001) of azficel-T. An autologous cell therapy, azficel-T is currently under review by the U.S. Food and Drug Administration for the treatment of moderate to severe nasolabial fold wrinkles.

8 Jul 2010