Regulatory news dominated the headlines in the past week. We have it summarized for you here.
—Sequenom (NASDAQ: SQMN) said a lack of adequate controls, protocols and supervision were to blame for the mishandled data that led the company to scrub its launch of a diagnostic test for Down syndrome. Sequenom shares lost 76 percent of their value last April when the company announced that the data needed to support the test had been mishandled.
—Tomorrow is the deadline for an FDA decision on Somaxon‘s (NASDAQ: SOMX) request to market its experimental insomnia drug doxepin (Silenor). The company has warned investors that approval isn’t likely.
—The FDA delayed an application from San Diego-based Amylin (NASDAQ: AMLN) and Indianapolis-based Eli Lilly to start marketing once-weekly exenatide for diabetes. The FDA’s “complete response letter” raised issues around finalizing the prescribing information that guides physicians, along with a Risk Evaluation and Mitigation Strategy (REMS) program and “clarification of existing manufacturing processes,” the companies said.
—San Diego-based Ligand Pharmaceuticals (NASDAQ: LGND) said today that its partner, GlaxoSmithKline, won European clearance to start marketing eltrombopag for idiopathic thrombocytopenia purpura (ITP), a rare bleeding disorder in which the immune system attacks platelet cells that help people form clots. The drug is marketed in the U.S as Promacta.
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