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Friday, May 30, 2008

FDA panel gives OK to Glaxo, Ligand drug

Surprise! A Food and Drug Administration advisory panel is backing approval for a blood-clotting drug being developed by GlaxoSmithKline and a San Diego firm.

The advisors voted unanimously today to recommend approval for Promacta to treat an immune system disorder. That's a bit of a surprise given that the FDA staff said the data indicated that the drug didn't work any better than a placebo in clinical testing.

After the staff report was released earlier in the week, the stock price of GlaxoSmithKline's development partner, Ligand Pharmaceuticals, plummeted to its lowest level in a decade. Today, Ligard shares popped up by more than 50 percent.

Shares of GlaxoSmithKline, which is a much bigger company, also rose on the action by the Oncologic Drugs Advisory Committee, rising little more than 1 percent.

The full FDA generally follows the recommendations of its advisory panels, but nothing requires it to do so. The key date for FDA action is June 19.
Posted by Mike Armstrong @ 2:04 PM  Permalink | Post a comment
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About Mike Armstrong
Mike Armstrong, a business editor and writer for nearly two decades, is the Inquirer's business columnist and PhillyInc blog editor. Contact Mike via e-mail or at 215-854-2980
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