Category: Food and Drug Administration

  •     By Kevin E. Noonan — The Food and Drug Administration posted a notice on its website today that further restricts prescription of two erythropoietin drugs (Amgen’s Epogen®/Aransesp® and Johnson & Johnson’s Procrit®) to cancer patients.  The notice is part of the FDA’s ongoing safety review of these drugs, and is a "follow-up" to…

  •     By Kevin E. Noonan — One of the promises of the genomics revolution of the late 20th Century is the advent of personalized medicine.  The belief was (and is) that the unfolding understanding of genetic variation stemming from sequence analysis of genes known or discovered to be involved in an individual’s response to…

  •     By Kevin E. Noonan — On Friday, the Court of Appeals for the Federal Circuit handed Pfizer a mixed decision on defendant Teva’s appeal of a District Court judgment that Teva was liable for infringing a trio of Pfizer patents (U.S. Patent Nos. 5,466,823; 5,563,165; and 5,760,068) relating to the pain medication Celebrex®…