May 2016

Senate approves brain cancer research Bill

Tuesday, May 31, 2016

The Senate Committee on Appropriations has approved legislation that provides for the inclusion of “brain cancer” among the disorders eligible for study by the Department of Defense‘s (DoD) Peer Reviewed Cancer Research Program (PRCRP). This provision was included in the fiscal year 2017 Defense Appropriations Act, and mirrors action taken by the House on May 11 to add brain cancer to the PRCRP in its version of the Defense Appropriations Act.

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FDA approves CSL Behring’s AFSTYLA for hemophilia A

Tuesday, May 31, 2016

CSL Behring has announced that the FDA has approved AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. AFSTYLA is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing.

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Study: Biomarkers improve drug LOA exponentially

Tuesday, May 31, 2016

The Biotechnology Innovation Organization (BIO) released a study of clinical development success rates. The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.

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Bioclinica launches OnPoint Direct

Tuesday, May 31, 2016

Bioclinica, a specialty clinical trials technology and services provider, has introduced OnPoint Direct, a Clinical Trial Management System (CTMS) geared toward mid-market biopharma and CROs. OnPoint Direct offers a cost-friendly pricing structure that empowers organizations to adopt a full-featured clinical trial management solution without the complex configuration, capital investment or perpetual licensing models customary of other systems.

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NIHR invests $23.4M in pediatrics research

Tuesday, May 31, 2016

A significant number of children experience long-term health conditions. This group’s health needs have not previously been given the research priority that they deserve. The NIHR has invested £21 million ($23.4 million) in 35 new studies focusing on improving the health outcomes for children and young people.

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Diverse populations—and transparent data—necessary for recruitment

Tuesday, May 31, 2016

The Pulse on Patient Recruitment by Ashley Tointon

Medicines affect various populations differently, so it is essential to have a diverse population when recruiting for clinical trials. Although specific patient recruitment tactics can be successfully deployed to reach certain sub-groups, there is a pervasive population disproportion in clinical trial participants. Such an understanding is the initial step to conquering the problem of minority recruitment. Once the gap is identified, the next and most difficult step is to implement actions designed to close the gap. 

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ClinTec International expanding in Spain to capitalize on improving Spanish market

Tuesday, May 31, 2016

With an improving Spanish pharmaceutical market, ClinTec International has identified the country as a target market for expansion. Following a year of steady growth by ClinTec’s Spain-based team, the global CRO is capitalizing on the improving Spanish economy by opening two new offices, and creating a new regional manager position, which will oversee both Spanish and Portuguese markets.

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