United States

NIH launches substance use and adolescent brain development study

Monday, September 28, 2015

The NIH has awarded 13 grants to research institutions around the country as part of a study about the effects of adolescent substance use on the developing brain. The Adolescent Brain Cognitive Development (ABCD) Study will follow about 10,000 children beginning at ages 9 and 10, before they initiate drug use, through the period of highest risk for substance use and other mental health disorders. Scientists will track exposure to substances (including nicotine, alcohol and marijuana), academic achievement, cognitive skills, mental health and brain structure and function using advanced research methods.

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FDA warns Sironis for unapproved trial

Monday, September 28, 2015

The FDA has sent a warning letter to Sironis, a medical devices and software developer, for running an unapproved clinical trial of its LIR closed-loop fluid administration system. The FDA said the Newport Beach, Calif.-based company never sought the proper approvals.

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ERT expands centralized respiratory solutions

Monday, September 28, 2015

ERT, a Philadelphia-based global provider of patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, has expanded its line of centralized respiratory solutions for global clinical trials. The offering enables trial sponsors to improve investigative site performance, trial efficiencies and data quality by leveraging centralized data surveillance to support risk-based monitoring in respiratory clinical research.

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Grants to help target genomic variants

Wednesday, September 23, 2015

Six new grants from the National Institutes of Health will support researchers to develop new computational approaches for searching among millions of genomic variants to find those that make a difference in disease susceptibility or in other traits. The awards are for three years each, and total about $13 million, pending the availability of funds. They are administered by the National Human Genome Research Institute (NHGRI) and the National Cancer Institute, both parts of NIH.

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Inovio receives $24M DARPA grant

Wednesday, September 23, 2015

Inovio Pharmaceuticals has announced that the U.S. Defense Advanced Research Projects Agency (DARPA) has exercised its option to provide an additional $24 million to support the Inovio-led development of multiple treatment and prevention approaches against Ebola. The option exercise, part of the $45 million Ebola program grant announced in April when Inovio received an initial $21 million award, was contingent upon Inovio successfully leading the completion of certain preclinical and clinical development milestones.

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