United States

TMF survey: technology adoption lagging, many sticking to paper and email

Monday, June 16, 2014 01:59 PM

Despite progress toward paperless clinical trials, email and paper remain the dominant forms of exchanging trial documents with sponsors and CROs, according to a new survey from Veeva Systems.

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WIRB Copernicus Group

Aspire IRB, Midlands IRB join WIRB-Copernicus Group

Monday, June 16, 2014 11:01 AM

Aspire IRB and Midlands IRB have joined the WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research.

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Burke Medical Research Institute receives $2M NIH grant for spinal cord repair

Friday, June 13, 2014 01:11 PM

Scientists at the Burke Medical Research Institute in White Plains, N.Y., have received a $2 million grant from the NIH to study ways to enhance the survival of cell transplants for spinal cord repair. Cell transplants are a potential therapy for spinal cord injuries, which affect hundreds of thousands of Americans and for which few treatment options currently exist.

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Cardiovascular Systems plans new corporate headquarters

Friday, June 13, 2014 01:07 PM

Cardiovascular Systems, a medical device company, has plans to build a new corporate headquarters in New Brighton, Minn. The 125,000-square-foot, two-story building will have space for more than 500 employees and contain dedicated R&D, training and education and manufacturing facilities. CSI’s headquarters will be located in the New Brighton Exchange, approximately 10 minutes from downtown Minneapolis.

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CSSi launches new division: CSSi LifeSciences

Thursday, June 12, 2014 01:32 PM

CSSi, a patient recruitment solutions provider, has formed a LifeSciences division. This entity was created to complement CSSi’s service offerings by providing guidance and support for all phases of the product lifecycle, from product concept and early planning to post-approval compliance and surveillance.

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FDA approves Bayer's Gadavist Injection for breast cancer

Thursday, June 12, 2014 12:41 PM

The FDA has approved a new indication for Bayer Healthcare’s Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two, multi-center, phase III studies (GEMMA-1 and GEMMA-2) conducted in 13 countries.

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Quintiles, American Physical Therapy Association develop outcomes registry

Wednesday, June 11, 2014 12:52 PM

Quintiles and the American Physical Therapy Association (APTA) have formed a new strategic collaboration to develop and implement the Physical Therapy Outcomes Registry, intended to be the largest and most comprehensive physical therapy electronic repository to date.

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NIH embraces 12-year scientific vision for BRAIN Initiative

Wednesday, June 11, 2014 12:50 PM

A federal report calls for $4.5 billion in funding for brain research over the next 12 years. The long-term scientific vision of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative was presented to NIH Director Francis S. Collins, M.D., Ph.D., by his Advisory Committee to the Director (ACD). Collins accepted the recommendations, calling the report bold and game changing.

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Synthetic Biologics, Enterome Bioscience collaborate

Wednesday, June 11, 2014 12:43 PM

Synthetic Biologics, a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, and Enterome Bioscience, a developer of innovative disease management solutions based on a deep understanding of the gut microbiome, have entered into an agreement to conduct metagenomic research on the effects of beta-lactam antibiotics on the gastrointestinal microflora (microbiome) of human patients.

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PaxVax, UC San Diego collaborate to develop herpes vaccine

Wednesday, June 11, 2014 12:40 PM

PaxVax, a specialty vaccine company with a commercial focus on travel and biodefense, has entered an R&D collaboration with the University of California, San Diego to develop a combination vaccine to prevent genital herpes simplex virus (HSV) infections.

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Reality of costs and impact rain on Sunshine Act
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