United States

BGI Tech, START collaborate on 1000 Cancer Genome Project

Monday, October 7, 2013 03:52 PM

BGI Tech Solutions, a subsidiary of BGI, a genomics research organization, and South Texas Accelerated Research Therapeutics (START), are collaborating on the San Antonio 1000 Cancer Genome Project (SA1kCGP), a cancer genome study designed to link genetic alterations that underlie different cancers to detailed clinical outcomes. Such findings could enable scientists to pursue the development of targeted, personalized cancer treatments. All data generated from SA1kCGP will be made available publicly and freely to researchers and others worldwide.

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WIRB Copernicus Group

Ben Venue Laboratories to cease production, cut all 1,100 jobs

Monday, October 7, 2013 01:33 PM

Ben Venue Laboratories, a Bedford, Ohio-based subsidiary of Boehringer Ingelheim that produces sterile injectables, has announced it will cease production by the end of 2013. Despite the ongoing support of the FDA, dedicated employees and investments in facility upgrades, the company cannot return to sustainable production.

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CRF Health eCOA webinar series

Stakeholders endorse Drug Quality and Security Act

Monday, October 7, 2013 01:18 PM

A broad range of stakeholders has endorsed the Drug Quality and Security Act, legislation introduced by Senate and House health policy leaders to address high-risk drug compounding practices and secure the pharmaceutical supply chain. The bill would improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.

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Commonwealth Laboratories, Cedars-Sinai ink agreement

Friday, October 4, 2013 01:32 PM

Commonwealth Laboratories, a diagnostic laboratory headquartered in Salem, Mass., and Cedars-Sinai Medical Center have signed an exclusive license agreement for three patents owned by Cedars-Sinai that cover technology developed by Mark Pimentel, M.D., FRCPC, director of Cedars-Sinai’s gastrointestinal motility program and laboratory, and Henry C. Lin, M.D. These patents describe the use of hydrogen and methane breath testing in the diagnosis of irritable bowel syndrome (IBS) and other disorders caused by small intestinal bacterial overgrowth (SIBO).

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Sun Pharma, Intrexon form joint venture for ocular diseases

Friday, October 4, 2013 01:28 PM

Sun Pharmaceutical Industries, an international specialty pharmaceutical company focused on chronic diseases, and Intrexon, a synthetic biology company, have formed a joint venture to develop controllable gene-based therapies for the treatment of ocular diseases that cause partial or total blindness. Initial targets are dry age-related macular degeneration (AMD), glaucoma and retinitis pigmentosa.

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FDA's report on chronic fatigue syndrome reveals impact, progress needed

Friday, October 4, 2013 01:23 PM

Pandora Org, a national nonprofit ME/CFS advocacy organization, and other patient organizations say a recent report from the FDA shows it must take further action to open up opportunities for ME/CFS drug development. Titled The Voice of the Patient, this report is a detailed summary of an April 25 FDA patient-focused drug development meeting, the first of its kind, at which patients explained the reality of Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS).

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DARPA awards Moderna Therapeutics $25m

Friday, October 4, 2013 01:20 PM

Moderna Therapeutics, a company focused on messenger RNA therapeutics, a new treatment modality to enable the in vivo production of therapeutic proteins, has been awarded up to $25 million to research and develop its messenger RNA therapeutics platform as a rapid and reliable way to make antibody-producing drugs to protect against a wide range of known and unknown emerging infectious diseases and engineered biological threats by the Defense Advanced Research Projects Agency (DARPA).

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Government shutdown already affecting clinical trials industry

Friday, October 4, 2013 08:58 AM

Last week, when the government shutdown began, stories of children with cancer unable to get into potentially life-saving trials at the National Institutes of Health (NIH) were the first clinical research-related ramifications reported.

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Report: Prescription drug utilization among elderly Americans has reached plateau

Wednesday, October 2, 2013 01:16 PM

A new white paper from life sciences advisory firm VOI Consulting shows that while a confluence of technical, medical and social factors led to dramatic growth in per capita prescription drug consumption in the U.S. over the past 20 years, long-range forecast suggests consumption levels have reached a saturation point. This means the U.S. pharmaceutical market will not experience a similar wave of sustained, industry-wide growth in the foreseeable future.

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Soligenix awarded NIAID contract

Wednesday, October 2, 2013 01:14 PM

Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense medical countermeasures (MCMs) for which there remains an unmet medical need, has been awarded a contract valued at up to $6.4 million by the U.S. Department of Health and Human Service's NIH (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID).

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July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

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