Clinical Intelligence

Clinical trials prove Canada's VSV-EBOV Ebola vaccine safe and effective

Thursday, April 2, 2015 02:46 PM

Canada's VSV-EBOV Ebola vaccine proved to be safe and effective in a phase I clinical trial, according to findings published in the New England Journal of Medicine. These studies were performed at the Walter Reed Army Institute of Research and the National Institute of Allergy and Infectious Diseases to explore the experimental vaccine's safety and what immune response it evokes when administered at different dosages.

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Quest Diagnostics

Enzalutamide, bicalutamide demonstrate positive results in Strive trial

Thursday, April 2, 2015 01:38 PM

Astellas Pharma and Medivation has announced topline results from the phase II STRIVE trial comparing enzalutamide with bicalutamide in a study population of men with non-metastatic or metastatic castration-resistant prostate cancer. The study achieved its primary endpoint demonstrating a statistically significant increase in progression-free survival (PFS) for enzalutamide compared with bicalutamide (Hazard Ratio = 0.24; 95% Confidence Interval, 0.18-0.32; p<0.0001). Median PFS was 19.4 months in the enzalutamide group compared with 5.7 months in the bicalutamide group.

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The CenterWatch Monthly, April 2015

Wednesday, April 1, 2015 08:42 AM

PSI, INC Research, Chiltern best with sites

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Parkinson's Biomarker Initiative expands genetic study

Friday, March 27, 2015 01:26 PM

The Parkinson's Progression Markers Initiative (PPMI), a large-scale biomarker study sponsored by the Michael J. Fox Foundation for Parkinson's Research (MJFF), is expanding to study individuals with a mutation of the GBA (glucosidase beta acid) gene. Participants will include people with or at increased risk to develop Parkinson's disease. Researchers hope that a greater understanding of the biology and clinical features of these participants will lead to therapies benefiting all Parkinson's patients and ultimately provide strategies to prevent disease onset.

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Mast to develop Vepoloxamer (MST-188) in chronic heart failure

Friday, March 27, 2015 01:15 PM

Mast Therapeutics, a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, arterial disease and heart failure, plans to develop vepoloxamer (MST-188) for the treatment of patients with chronic heart failure. Encouraged by recently reported nonclinical results and input from experts in the field, the company expects to begin dosing in a phase II study of vepoloxamer in patients with chronic heart failure in the third quarter of this year.

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FDA approves treatment for inhalation anthrax

Thursday, March 26, 2015 02:31 PM

The FDA has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

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Selten Pharma receives FDA Orphan Drug designation for PAH

Thursday, March 19, 2015 01:13 PM

Selten Pharma, a privatively held biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases, has announced its lead compound tacrolimus (SPI-026) has been granted Orphan Drug designation by the FDA for the treatment of pulmonary arterial hypertension (PAH).

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Can-Fite completes commercial biomarker test to predict patients' drug response

Thursday, March 19, 2015 01:09 PM

Can-Fite BioPharma, a Israel-based biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR). The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite's drugs, which currently are in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.

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XBiotech launches cancer patient directed web site and call center

Monday, March 16, 2015 09:00 AM

XBiotech, an Austin, Texas-based developer of next generation therapeutic antibodies, has launched a web site and call center to help patients with metastatic colorectal cancer learn about its U.S. pivotal phase III clinical trial. The phase III study, Xilonix Colorectal cancer Immunotherapy Treatment Evaluation (XCITE), assesses XBiotech's True Human monoclonal antibody (Xilonix) for the treatment of metastatic colon cancer.

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NIH-led study to assess community-based Hepatitis C treatment in Washington, D.C.

Thursday, March 12, 2015 12:52 PM

Officials from the National Institutes of Health and the city of Washington, D.C., launched a clinical trial to examine whether primary care physicians and other health care providers, such as nurse practitioners and physician assistants, can use a new antiviral therapy as effectively as specialist physicians to treat people with hepatitis C virus (HCV) infection. The trial, which will involve 600 adult D.C. residents infected with HCV alone or co-infected with HCV and HIV, also will examine the long-term effects of the treatment.

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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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