Novel inhibitor of PCSK9 lowers LDL cholesterol far beyond what can be achieved by statins. Investigators report reductions of 40% to 72% in new Phase II trial.
Based on the results and reception of a Phase II study for the PCSK9 inhibitor REGN727/SAR236553, Regeneron Pharmaceuticals Inc./Sanoficould have a “game changer” for lipid disorders on their hands, but they are also likely to face demand for outcomes data and fears about autoimmunity if they target large potential patient populations.
PCSK9, or proprotein convertase subtilisin/kexin type 9, is a protein thought to cause the destruction of LDL receptors, making it...
Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.
While challenges in the US present an “incredible opportunity” for Europe, there is no “doomsday” happening there, Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
