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.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
