|FDA advisory panel backs Pfizer pancreatic drug|
|By Staff and Wire Reports|
|Tuesday, 12 April 2011 18:21|
Pfizer Inc. (NYSE:PFE) announced today that the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) voted 8-2 that SUTENT provides a favorable benefit-risk profile for the treatment of unresectable pancreatic neuroendocrine tumors (NET). The panel’s advice will be considered by the FDA when finalizing its review of Pfizer’s supplemental New Drug Application (sNDA) for sunitinib for this indication.
"We are encouraged by the panel’s favorable review of sunitinib for the treatment of unresectable pancreatic NET. Following today's discussion, we will work closely with the FDA to ensure that it has all of the information that it needs to finalize its review," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. "If approved in the United States, sunitinib would be a major advancement in the treatment of patients with pancreatic NET, a disease for which there remains a significant unmet medical need."
Echo Therapeutics, Inc. (OTCBB:ECTE.ob), a company developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude SkinPrep System for transdermal drug delivery, today announced that it received a notice of allowance for U.S. Patent Application No.11/275,038, "System and Method for Continuous Non-Invasive Glucose Monitoring," for the Symphony tCGM System.
The patent, describing the method of use for the Symphony tCGM System in the hospital critical care setting, has been allowed in the United States and is expected to issue in the next few months. The patent will expire in December 2025.
"Building on our positive fundamentals, we are excited to be issued this notice of allowance for a key component of our intellectual property portfolio," stated Patrick Mooney, M.D., Echo's Chairman and CEO. "This patent is critical to our intellectual property strategy for protecting our leading position in non-invasive, tCGM markets worldwide. Furthermore, we expect several additional patents to issue this year worldwide for both our Prelude SkinPrep System and our Symphony System as we build a solid foundation for future growth. We expect these patents will add significantly to our shareholder value in both the near- and long-term."
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market Accell Evo3 Demineralized Bone Matrix as a bone void filler product for use in the posterolateral spine.