Category Archives: R&D

Big Data in the Pharma R&D Landscape

Big Data and the mindset that comes with it will have a fundamental impact on how pharmaceutical research will be conducted in the future, writes Peter Tormay. Innovation is the corner stone of the pharmaceutical industry. Unfortunately, the industry as a whole is not very good at it. For the last two decades the approval […]
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Rebranding Risk-Based Monitoring in Clinical R&D

With all of the buzz and excitement around risk-based monitoring (RBM), one might expect that the broad adoption of this emerging clinical research paradigm is well underway. Those familiar with the often painfully slow pace of innovation in the area of clinical R&D, however, will not be surprised by the more sobering reality that only […]
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Sanofi Reports Progress Toward First Dengue Vaccine

Sanofi Pasteur, the vaccines division of Sanofi, reports that results of an efficacy study is a step closer to making dengue the next vaccine-preventable disease. Sanofi points to The Lancet’s published results showing the overall efficacy of the drug maker’s vaccine against symptomatic dengue in 56.5% in children aged 2 to 14 years old after […]
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Sandoz Wins Biosimilar Filing Race

 After months of speculation about prospects for biosimilar development in the U.S., Novartis announced July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the […]
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NIH Translational Research Partnership Yields Promising Therapy

A potential treatment for sickle cell disease has come through the “valley of death” of early stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The results of early clinical trials demonstrated sufficient effectiveness in addressing the underlying […]
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