United States

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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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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CWWeekly

December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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