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Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved its co-primary endpoint of superiority of Cayston for mean actual change in forced expiratory volume in one second (FEV1, a measure of lung function) percent predicted across three treatment cycles (six months).

22 Oct 2010

Research suggests lowering cholesterol can reduce benign prostatic hyperplasia

A cholesterol-lowering drug reduced the enlarged prostates of hamsters to the same extent as a drug commonly used to treat benign prostatic hyperplasia (BPH), report researchers at Children's Hospital Boston and their colleagues in the October issue of the Journal of Urology. Together, the drugs worked even better.

22 Oct 2010

Researchers suggest gene therapy may treat patients with major depression

In a report published in the Oct. 20 issue of Science Translational Medicine, researchers at NewYork-Presbyterian Hospital/Weill Cornell Medical Center say animal and human data suggest gene therapy to the brain may be able to treat patients with major depression who do not respond to traditional drug treatment.

22 Oct 2010

Novartis releases study results on oral calcitonin for treatment of osteoarthritis: Unigene Laboratories

Unigene Laboratories, Inc. announced today that Novartis has released information on the first of two studies on oral calcitonin for the treatment of osteoarthritis conducted by its license partner Nordic Bioscience. The recently completed Study 2301, which assesses the safety and efficacy of oral calcitonin in the treatment of knee osteoarthritis, had three co-primary endpoints.

22 Oct 2010

Idera announces IMO-3100 Phase 1 clinical trial results for autoimmune disease

Idera Pharmaceuticals, Inc. today announced results from its single-dose, dose-escalation Phase 1 clinical trial evaluating the safety and mechanism of action of IMO-3100, its lead Toll-like Receptor (TLR) 7 and TLR9 antagonist drug candidate for the treatment of autoimmune and inflammatory diseases.

22 Oct 2010

Advaxis completes patient recruitment in ADXS11-001 phase II study for cervical dysplasia

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, completes recruitment of the first group of patients in its US cervical dysplasia (CIN) phase II study of ADXS11-001 as required for the planned DMSB (safety board) meeting scheduled to be held January 11, 2011.

22 Oct 2010

Celtic Pharma receives US patent for methods to treat breast, colon cancer

Celtic Pharmaceutical Holdings L.P. today announced that the U.S. Patent Office has issued U.S. patent 7,816,323, for novel methods to treat breast and colon cancers using a combination therapy of Xerecept with Avastin.

22 Oct 2010

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

Cardiome Pharma Corp. today announced that its co-development partner, Astellas Pharma US., Inc., has suspended patient enrollment in the ACT 5 study of KYNAPIDTM (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received KYNAPID.

21 Oct 2010

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

PolyMedix, Inc., a biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has announced plans for a Phase 2 clinical trial of PMX-60056 in interventional cardiology, and the establishment of a focused Heptagonist Clinical Advisory Board (CAB). PMX-60056 is a synthetic small-molecule designed to reverse the anticoagulant activity of heparin and low molecular weight heparins (LMWH).

21 Oct 2010

Baxter third quarter net income increases 12% to $595 million

Baxter International Inc. today announced its financial results for the third quarter of 2010, and provided its fourth quarter and updated full-year 2010 financial outlook.

From Baxter International Inc. 21 Oct 2010

Venn Life Sciences acquires French CRO

Venn Life Sciences a multinational Clinical Research Organisation (CRO) announced today that it has acquired French CRO, DCI.

21 Oct 2010

ISCTM to develop solutions for CNS clinical trial methodology

The International Society for CNS Clinical Trials and Methodology (ISCTM) met recently to develop solutions to challenges facing CNS clinical trial methodology.

21 Oct 2010

Hormone therapy associated with increased risk of death from breast cancer

Results of a new Women's Health Initiative (WHI) report show that hormone therapy is associated with an increased the risk of death from breast cancer, as well as an increased risk of developing invasive breast cancer in postmenopausal women.

21 Oct 2010

Hormone therapy increases breast cancer mortality risk, study finds

Hormone treatment after menopause, already known to increase the risk of breast cancer, also makes it more likely that the cancer will be advanced and deadly, a study finds.

21 Oct 2010

Study on health effects of alcohol consumption with HIV

Living with HIV is difficult under the best of circumstances, but for people carrying the virus, alcohol consumption can become particularly perilous in intricate ways that are only beginning to be understood. At the Brown Alcohol Research Center on HIV (ARCH) funded by a new $7.5-million, five-year grant from the National Institutes of Health, Brown University scientists will study the health effects of drinking with HIV and provide doctors and patients with the latest guidance their results suggest.

21 Oct 2010

Agensys and Seattle Genetics initiate ASG-5ME phase I clinical trial for castration-resistant prostate cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., and Seattle Genetics, Inc. today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of castration-resistant prostate cancer. ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen and is being co-developed by both companies for the treatment of solid tumors.

21 Oct 2010

Researchers to study effect of reovirus on cancer cells

A common virus that can cause coughing and mild diarrhea appears to have a major redemptive quality: the ability to kill cancer. Harnessing that power, researchers at Georgetown Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center, are conducting a clinical trial to see if the virus can target and kill certain tumor types.

21 Oct 2010

Generex announces participation in Annual Canadian Diabetes Association Conference

Generex Biotechnology Corporation today announced that it will be attending the 13th Annual Canadian Diabetes Association (CDA)/ Canadian Society of Endocrinology and Metabolism (CSEM)Professional Conference and Annual Meetings in Edmonton, Alberta. The gathering will run from October 20-23, 2010 at the Shaw Conference Centre.

21 Oct 2010

DMC concludes Protege Phase 3 clinical trial for type 1 diabetes lacks efficacy

MacroGenics, Inc. and Eli Lilly and Company today announced that the Protege Data Monitoring Committee (DMC), composed of independent experts in the fields of diabetes and biostatistics, has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab, an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.

21 Oct 2010

Genzyme third quarter revenue increases to $1.0 billion

Genzyme Corp. today reported third-quarter earnings growth driven by increased shipments of Cerezyme® (imiglucerase for injection). Patients in the United States began returning to normal dosing levels last month, and patients globally are expected to be able to do so this quarter. Earnings growth in the third quarter was also driven by strong revenue from Lumizyme™ (alglucosidase alfa) and cost reduction measures.

21 Oct 2010