FDA advisory panel backs Pfizer pancreatic drug Print E-mail
By Staff and Wire Reports   
Tuesday, 12 April 2011 18:21
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 12, 2011.

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.

Also Tuesday:


eHealth, Inc. (NASDAQ: EHTH), the leading online source of health insurance for individuals, families, and small businesses, announced today that the company plans to release first quarter 2011 financial results on April 26, 2011.

Healthcare Services Group, Inc. (NASDAQ: HCSG) reported that revenues for the three months ended March 31, 2011 increased over 13% to $208,390,000 compared to $183,801,000 for the same 2010 period.

Healthnostics, Inc. (PINKSHEETS: HNSS) reported preliminary 1st Quarter revenue of $487,000 and profit of $278,000.

Imaging3, Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced that the company's Chairman and CEO Dean Janes was interviewed on Thursday, April 7, 2011, on MoneyTV, a business and investment oriented television program.

Marina Biotech, Inc. (NASDAQ: MRNA), a leading RNAi-based drug discovery and development company, today announced that the Canadian Patent Office has issued a Notice of Allowance for patent application 2,438,116 with claims that broadly cover amphoteric liposomal formulations (SMARTICLES®)and their use for the delivery of nucleic acids and other compounds with therapeutic application.

MedeFile International, Inc. (OTCQB:MDFI) (PINKSHEETS: MDFI), a leader in Internet-enabled Personal Health Record (iPHR) management solutions, today reported that Kevin Hauser, Chairman, President and Chief Executive Officer of the Company, has increased his equity ownership stake in MedeFile's common stock to 9.8% from 1.1%.

WellTek, Inc. (OTCBB: WTKN), a global health, fitness and wellness company, today announced the acquisition ofStem Cells for Hope, Inc. (SCFH), a leading provider of stem cell transplantation therapy technologies for patients worldwide.

 



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