Verbal feedback from FDA on a package of nephrotoxicity biomarkers submitted by a consortium of drug companies "has been quite positive, so we expect a good read," Critical Path Institute CEO Raymond Woosley tells "The Pink Sheet." The agency is reviewing data on seven biomarkers as part of a pilot program to determine how to qualify biomarkers for specific uses. Data indicate they are "far more sensitive and can pick up injury much earlier and with much greater specificity" than existing indicators of kidney disease, he says. The same firms are planning a clinical trial "to get these not just used in drug development, but used in medicine," Woosley says. The consortium operates under the auspices of C-Path (1"The Pink Sheet" July 9, 2007, p. 3)...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
