United States

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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WIRB Copernicus Group

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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FDA launches openFDA to provide easier access to FDA public health datasets

Monday, June 2, 2014 01:19 PM

The FDA has launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.

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Sangamo BioSciences, City of Hope granted $5.6M from CIRM

Friday, May 30, 2014 01:36 PM

The California Institute for Regenerative Medicine (CIRM) has granted a $5.6 million Strategic Partnership Award to fund clinical studies at City of Hope to develop a potentially curative ZFP therapeutic for HIV/AIDS based on the application of SangamoBioSciences' zinc finger nuclease (ZFN) genome-editing technology in hematopoietic stem/progenitor cells (HSPCs).

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Trimel receives FDA approval for Natesto Nasal Gel male low testosterone

Friday, May 30, 2014 01:33 PM

The FDA has approved Trimel Pharmaceuticals’ Natesto (testosterone), formerly CompleoTRT, a testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator, thereby minimizing the risk of secondary exposure to testosterone of women or children.

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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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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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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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