September 2010 Issues

European Society of Cataract and Refractive Surgeons (ESCRS) -- Quick Pulse
Summary: Despite the continuing European and U.S. financial woes, traffic was surprisingly brisk at ESCRS. Some industry sources said doctors are looking and even buying.  In fact, many industry sources said they generated more new leads in the first two days of ESCRS than at the entire meeting last year. However, most ophthalmic companies said the situation is still bad.

FDA Restricts Use of GSK's Avandia While European Regulators Ban Use -- Quick Pulse
Summary: FDA Commissioner Margaret Hamburg announced that “as a matter of prudence” the FDA is restricting access to GlaxoSmithKline’s Avandia (rosiglitazone) but not pulling it from the market because of cardiovascular safety concerns. She said, “The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks. We are seeking to strike the right balance to support clinical care.”

FDA Advisory Committee Recommends Approval of AstraZeneca's Antiplatelet Agent Brilinta Despite Troublesome Data on U.S. Patients -- Quick Pulse
Summary: The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted overwhelmingly to recommend approval of AstraZeneca’s Brilinta (ticagrelor), despite concerns about why the drug did not work in U.S. patients in the pivotal trial. The panel voted 7 to 1 that Brilinta should be approved for patients undergoing percutaneous coronary interventions (PCI) to open blocked arteries, and the panel voted 7 to 1 that it should be approved for patients being managed medically or not expected to get an invasive procedure.