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Ionis, Merck and Lundbeck offered feedback on the FDA’s guidance for developing natural history studies for rare disease drug development, praising some parts of the guidance but calling for more details. Read More
Congressional panels have taken turns bashing benefits managers as “middlemen” who inflate the cost of prescription drugs while adding little to the drug supply chain. Read More
The EU also recognizes the regulatory oversight of active substances by competent authorities in the U.S., Australia, Brazil, Israel, Japan and Switzerland. Read More
Illinois-based compounder PharMedium Services has been ordered to shut down operations at its Tennessee site after repeated warnings from the FDA to clean up its act. Read More
A key Senate committee is seeking public comment on a package of bills that backers say would rein in the costs of prescription drugs and restore order to the healthcare system. Read More
Generics makers are claiming vindication after a Federal Trade Commission report found only a single patent case was settled with “pay-for-delay” tactics in fiscal 2016—the lowest level since the government began tracking such settlements. Read More
“Gilead bore the risk and the vast majority of the cost of research and clinical studies to demonstrate Truvada’s efficacy and safety as part of combination HIV therapy,” O’Day told the panel. Read More