Sequenom Speaks Out, Amylin Receives a Setback, Somaxon Awaits FDA Decision, & More San Diego Life Sciences News

Xconomy San Diego — 

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.

—Luke located more than 170 alums of Hybritech, the company that gave birth to San Diego’s biotechnology industry.

—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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2 responses to “Sequenom Speaks Out, Amylin Receives a Setback, Somaxon Awaits FDA Decision, & More San Diego Life Sciences News”

  1. Robert G says:

    Regarding SQNM, stop killing a pure play that is going to save and give hope with their testing. This old news, it’s about time reporters and financial wizards get a life. SQNM has said they made mistakes, but they took action and made changes with the responsible employees. Another words they cleaned the house. How about taking a different spin with reporting what is positive or what products they did bring to market successfully.

  2. JB says:

    Well, where I’m from they say when you make a bed you got to lay in it. Accountablity, (or lack thereof) always begins at the top.