June 2010 Issues

FDA Advisory Panel Clears the Use of GSK's Rotarix and Merck's RotaTeq -- Quick Pulse

Summary: Both rotavirus vaccines -- GlaxoSmithKline’s (GSK’s) Rotarix and Merck’s RotaTeq -- are safe to use.  That is the FDA’s latest decision, and the Agency followed the advice of its Vaccines and Related Biological Products Advisory Committee.  However, the Centers for Disease Control and Prevention (CDC) recently warned that neither vaccine should be given to infants with severe combined immunodeficiency (SCID).

EuroPCR

Summary: Abbott’s BVS bioabsorbable stent was generating interest, but there are issues with it as well. ♦ Johnson & Johnson’s Nevo is looking very promising and could be the next big news in DES. ♦ Medtronic’s Resolute stent proved non-inferior to Abbott’s market leading Xience V, but doctors were not impressed because of the early stent thrombosis rate, so it may replace Endeavor without expanding Medtronic’s market share much. ♦ The economic climate is starting to put some pressure on percutaneous valve volume, and experts are concerned it will stifle innovation. ♦ New data on Abbott’s MitraClip for percutaneous mitral valve repair were good, but enthusiasm remains muted because of cost and the difficulty of the procedure. ♦ Doctors are not yet convinced of the usefulness of platelet aggregation measurement with Accumetrics’ VerifyNow to guide therapy.