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Venn Life Sciences acquires French CRO Cardinal Systems

Monday, August 11, 2014 01:42 PM

Venn Life Sciences, a growing CRO providing clinical trial management and resourcing solutions to pharmaceutical, biotechnology and medical device clients, has acquired Cardinal Systems, a France-based CRO specializing in data management and randomization systems.

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Sanofi licenses Immune Design's GLAAS platform to treat food allergies

Monday, August 11, 2014 01:38 PM

Sanofi and Immune Design, a clinical-stage immunotherapy company, have entered into a licensing agreement for use of Immune Design's GLAAS discovery platform to develop therapeutic agents to treat a selected food allergy.

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Cancer Research U.K., Cancer Research Technology ink agreement with Astellas

Monday, August 11, 2014 01:35 PM

Cancer Research U.K. and its commercial arm, Cancer Research Technology (CRT), have joined with Astellas Pharma to conduct a two-year research program in the U.K. to find new drug targets in the fight against cancer, with an initial focus on pancreatic cancer.

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The Pulse on Site Success

Monday, August 11, 2014 07:00 AM

For many years, Research Across America (RAA) has owned a mobile van affectionately known as “Barney” because of its color, purple!

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YourEncore launches regulatory center of excellence

Friday, August 8, 2014 01:12 PM

YourEncore, which helps life sciences, consumer products and food companies solve complex innovation, compliance and productivity challenges, has launched the Regulatory Center of Excellence, to provide life sciences companies with industry-accomplished experts to guide them through complex regulatory requirements, from phase I trials through approval.

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ACRP, IAOCR collaborate on combined program suites

Friday, August 8, 2014 01:10 PM

The Association of Clinical Research Professionals (ACRP) and the U.K.-based International Academy of Clinical Research (IAoCR), provider of accreditation, training and consultancy for clinical researchers, are collaborating to offer services and establish recognized global standards of clinical research.

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Igenica Biotherapeutics awarded SBIR grant for antibody drug conjugate technology

Friday, August 8, 2014 01:09 PM

Igenica Biotherapeutics, focused on the discovery and development of innovative cancer antibody-drug conjugates (ADCs), has been awarded a $215,740 Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to support continued development of its SNAP site-specific ADC linker technology.

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FDA approves Orbactiv to treat skin infections

Friday, August 8, 2014 12:44 PM

The FDA has approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.

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BioSpecifics Technologies initiates phase II study of CCH for Lipoma

Friday, August 8, 2014 12:33 PM

BioSpecifics Technologies, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX in the E.U., has injected the first patient in its placebo-controlled phase II clinical trial of CCH for the treatment of lipoma. The company expects to complete patient enrollment in this trial during the first quarter of 2015.

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Theravance appoints Michael W. Aguiar as president, CEO

Friday, August 8, 2014 12:29 PM

Theravance has appointed Michael W. Aguiar as president and CEO effective August 15, and as a member of the board of directors effective immediately. Aguiar plans to continue to as Theravance's senior vice president and chief financial officer until his replacement is identified and appointed. 

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September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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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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