United States

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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WIRB Copernicus Group

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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CRF Health eCOA webinar series

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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Cantab Connect launches cognitive safety assessment products for tablets

Monday, June 9, 2014 02:00 PM

Cambridge Cognition has launched its first two iPad-tablet products on its new cloud computing Cantab Connect platform for use in clinical trials. Current practice still relies largely on pen and paper questionnaires with widespread potential for inaccuracies.

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BioDelivery Sciences receives FDA approval for BUNAVAIL for opioid dependence

Monday, June 9, 2014 10:24 AM

BioDelivery Sciences International has received approval of the NDA for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) from the FDA. BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014.

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Techorizon to launch TH-eClinical suite at DIA

Thursday, June 5, 2014 11:00 AM

Techorizon, a provider of clinical technology solutions, will launch the TH-eClinical suite of clinical research products June 17 at the DIA Annual Meeting in San Diego.

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

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

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