Clinical Intelligence

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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Quest Diagnostics

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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CardioCell adds Stony Brook University to sites conducting phase IIa trial

Thursday, March 12, 2015 12:31 PM

CardioCell, a Stemedica Cell Technologies subsidiary that designs allogeneic stem-cell therapies for cardiovascular indications, has expanded patient recruitment to Stony Brook University’s Heart Institute for its phase IIa clinical trial for chronic heart failure (HF). Recruitment for 20 qualified patients currently is underway at only Emory University in Atlanta, Northwestern University in Chicago, Stony Brook University on Long Island and the University of Pennsylvania in Philadelphia.

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One World Cannabis, Sheba Academic Medical Center ink trial agreement

Thursday, March 12, 2015 12:13 PM

OWC Pharmaceutical Research's wholly owned subsidiary One World Cannabis, an Israel-based company focused on medical cannabis treatment and medical cannabis regulatory affairs, has signed a collaboration agreement with Sheba Academic Medical Center, the largest hospital in Israel and in the Middle East.

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FDA expands approved use of Opdivo to treat lung cancer

Thursday, March 5, 2015 01:42 PM

The FDA has expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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Asterias Biotherapeutics initiates trial for complete cervical spinal cord injury

Thursday, March 5, 2015 01:34 PM

Asterias Biotherapeutics, a biotechnology company in the emerging field of regenerative medicine, announced that Atlanta-based Shepherd Center, a rehabilitation hospital for spinal cord injury and brain injury, has commenced enrollment for the phase I/IIa clinical trial of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI).

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VolitionRx initiates second prostate cancer study assessing nucleosomics technology

Thursday, March 5, 2015 12:23 PM

VolitionRx, a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, has initiated a pilot study to assess the feasibility of VolitionRx's proprietary NuQ assays in detecting prostate cancer. The study is in collaboration with ImmuneHealth, a global biomarker CRO, and is taking place in Belgium.

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CWWeekly

May 26

inVentiv Health aims to help sponsors prepare for new E.U. regulations on observational studies

ACRP partners with CRO Analytics to measure investigative sites' views of clinical trial quality

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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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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