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Latest From AstraZeneca Pharmaceuticals LP
Agency rejects PhRMA requests to ease certification process and limit rule's application; separately, law firm Hyman, Phelps & McNamara objects to FDA practice of delaying ANDA approval announcements until it issues a petition decision.
AstraZeneca's legal gambit results in almost two more weeks of sales for the statin even though the court ultimately agreed with FDA on labeling carve-out for orphan indication.
Court postpones a decision on a temporary restraining order and asks parties to reach agreement on how FDA is to proceed with pending ANDAs.
Roche Molecular Diagnostic's top researcher, Walter Koch, discusses the promise of liquid biopsy following FDA's recent approval of its first liquid-biopsy companion diagnostic, Roche's cobas test for the cancer drug Tarceva.
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