Author Archives: Guest Blogger

The Year of Living Openly: Europe and Transparency 2015

The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes. The regulators have prioritized transparency and harmonization for some time but underscored them to an even greater degree in 2014; 2015 is likely to see the trend intensify.
Posted in compliance, Europe, Global, Guest Blog | Tagged , , , , , , | Leave a comment

‘Warehousing’ and the Future of HCV Treatment

The battle against hepatitis C (HCV) is a relatively new, and highly dynamic, one.  The viral disease was only discovered in the 1980’s and, according to WHO estimates, some 3% of the world’s population are now infected with HCV and there are more than 170 million chronic carriers. So what does the HCV treatment landscape look […]
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Tufts Figures on Drug Development Spark Debate

By Agnes Shanley, Pharmaceutical Technology. The Tufts University Center for the Study of Drug Development (CSDD) released its latest research on the costs and timeframes required for launching a new drug. Although the study acknowledges that it still takes about 10 years to launch a new brand-name pharmaceutical, this year, the costs required were estimated at $2.6 […]
Posted in R&D, Strategy | Tagged , , | 1 Comment

FDA "Stymies Competition in Drug Industry", Says PCMA

By Randi Hernandez. The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation’s leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace. The PCMA argues that competition within branded drugs […]
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No-One's in Charge of Pharmaceuticals in Europe!

Peter O’Donnell’s recent Applied Clinical Trials blog, ‘Who’s in charge of Medicines in Brussels?‘, has been overtaken by history, with the departure of Guido Rasi from his post of Executive Director of the European Medicines Agency. At a time of flux in the European context for pharmaceuticals, Rasi’s moderate manner and capacity for strategic thinking […]
Posted in Europe, Regulatory | Tagged , , | Leave a comment
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