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PRA Health Sciences expands in Pennsylvania

Wednesday, September 3, 2014 12:44 PM

PRA Health Science, a global CRO, is relocating Pennsylvania-based employees from its Horsham and Fort Washington locations into new office space in Blue Bell. The new office has opened and marks the first phase of PRA’s relocation plan. It soon will be PRA’s largest office worldwide.

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NICE releases guidelines to improve recording of drug allergies

Wednesday, September 3, 2014 12:43 PM

Redesigning prescriptions to include information on drugs or drug classes that patients with known drug allergies should avoid can reduce the risk of allergic reactions, according to the National Institute of Health and Care Excellence (NICE).

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Exelixis cuts 70% of employees following failed pivotal trial

Wednesday, September 3, 2014 12:41 PM

Exelixis, a California-based biopharmaceutical company developing small molecule therapies for cancer, has announced top-line results from the final analysis of COMET-1, the phase III pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide. The trial did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone.

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Chimerix wins contract extension for development of smallpox treatment

Wednesday, September 3, 2014 12:39 PM

Chimerix, a Durham, N.C., biopharmaceutical company developing novel, oral antivirals, has been awarded a $17 million extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of its broad spectrum antiviral brincidofovir (BCV, CMX001) as a medical countermeasure to treat smallpox.

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Onyx Scientific, Cancer Research U.K. partner

Wednesday, September 3, 2014 12:30 PM

Cancer Research U.K. is using Onyx Scientific, a U.K. CRO, to manage several of its drug development projects in a bid to maximize value.

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TransCelerate releases recommended approach for protecting personal data in Clinical Study Reports

Wednesday, September 3, 2014 08:20 AM

TransCelerate BioPharma has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others.

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The regulatory landscape in South Korea and China

Tuesday, September 2, 2014 07:00 AM

My last two columns have focused on regional guidelines for clinical trial recruitment, to provide context for engaging in advanced targeting and acquisition methods—such as online advertising, search engine marketing and social media—to engage prospective participants. 

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The CenterWatch Monthly, September 2014

Tuesday, September 2, 2014 07:00 AM
Today’s fastest, most economical sponsors

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Rally for Medical Research to urge Congress to prioritize NIH funding

Friday, August 29, 2014 11:21 AM

While the ice bucket challenge has raised awareness—and millions of dollars—for ALS research, participants from nearly 300 research institutions and medical advocacy organizations are taking a much drier, and broader, approach to fund raising.

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WHO recommends use of testing to help diagnose pre-cancerous cervical disease

Friday, August 29, 2014 10:33 AM

The World Health Organization (WHO) has issued new guidance recommending the use of p16 immunohistochemistry (IHC) testing to improve the detection of pre-cancerous cervical disease. In doing so, WHO is the first global organization to issue written recommendations on the use of p16 after the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) provided similar guidance in 2012.

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September 22

Roche/Genentech plans pilot trial to measure patientpreference for participating at home v. at study site

Bipartisan 21st Century Cures initiative prepares to draft legislation to accelerate biomedical R&D, lower cost

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The CenterWatch Monthly

September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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