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Merz Pharmaceuticals Announce Three Studies Of NT-201 - (Botulinum Neurotoxin Type A Free From Complexing Proteins)
Results from three placebo controlled studies conducted to assess NT-201 in upper limb post-stroke spasticity, pre-treated cervical dystonia, and treatment-naive cervical dystonia patients represent the second data set presented at the Movement Disorder Society (MDS) 13th Annual International Congress in Paris, France. The studies were sponsored by Merz Pharmaceuticals, which plans to file a Biologic License Application (BLA) for NT-201 in the USA in the near future.
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Emergent BioSolutions Receives FDA Approval Extending Shelf Life Of BioThrax (Anthrax Vaccine Adsorbed) To 4 Years
Emergent BioSolutions Inc. (NYSE:EBS) announced that its flagship product, BioThrax® (Anthrax Vaccine Adsorbed), has been granted a shelf life extension from 3 to 4 years by the U.S. Food and Drug Administration (FDA). Based on this approval, Emergent has achieved a contract milestone warranting a payment of approximately $30 million for doses previously delivered to the Strategic National Stockpile (SNS) under the terms of the company"s existing BioThrax procurement contracts with the Department of Health and Human Services (HHS). This amount is expected to be recognized as revenue in the second quarter of 2009. In addition, FDA approval of 4-year expiry dating results in an immediate price increase for the future delivery of BioThrax doses under the current contract as well as under the follow-on multi-year contract, valued at $405 million, for the delivery of 14.5 million doses of BioThrax. Drugshop to buy zoloft online and other pills.
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Sen. Sessions To Give Floor Speeches On Judiciary As GOP Prepares For Sotomayor Debate
Sen. Jeff Sessions (R-Ala.), the ranking member on the Senate Judiciary Committee, on Wednesday is expected to outline the Republican Party"s vision for the judiciary and the kinds of judges the GOP supports for the Supreme Court in the first of a series of floor speeches, according to committee s, Roll Call reports. Although the speeches are not directly targeted at Supreme Court nominee Judge Sonia Sotomayor, Sessions said he hopes they will begin a "national dialogue" on the judiciary"s role ahead of her confirmation hearing, which is scheduled to begin July 13. Sessions is expected to give four to five speeches, which also will appear as opinion pieces in the Washington Times this week. His first speech will address his views on the foundation of a strong judiciary and judicial restraint. The later speeches will focus on President Obama"s call for judges who display "empathy" and other issues, according to Roll Call. The committee said the speeches "will address the fundamental issues that will be in play during the confirmation process" and "make the case for judicial restraint versus judicial activism."According to Roll Call, part of Sessions" motivation for giving the speeches is to clarify the definition of terms like "judicial restraint," "activist judge" and "empathy standard," phrases that frequently arise in debates over judges but might not be widely understood among judicial outsiders and the general public. Senators are expected to question Sotomayor on such topics during her confirmation hearing, and Sessions aims to define the context of the terms before the hearings begin, Roll Call reports. Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) said that he is optimistic that Sotomayor"s hearings will remain bipartisan and that Republicans would not attempt to derail them by boycotting the hearings. He added that he believes GOP senators will participate in the hearings despite their complaints that they have not had enough time to prepare (Stanton, Roll Call, 6/17).
Endocrinology

Nanopatches To Join The Fight Against Swine Flu

In response to the growing threat of swine flu, a UQ team is applying nanopatch technology to potentially solve the problems associated with vaccinating millions of Australians, thanks to a recently announced government grant. Australian Institute for Bioengineering and Nanotechnology (AIBN) researcher Professor Mark Kendall heads a team testing the potency of mass vaccinations using only a fraction of the standard dose. The project also targets cross-protection by delivering the seasonal vaccine to protect against challenge from the swine A H1N1 influenza virus. Professor Kendall said this research used new nanopatch technology which does away with the needle and syringe and stimulated a potent immune response with a reduced dose. "By accurately and reliably delivering the vaccine to the abundant immune cells, which are located just under of the surface of the skin, we are able to initiate a rapid and powerful immune response from the body, while using considerably less vaccine," Professor Kendall said. "The beauty of the nanopatch is that it could enable large-scale rapid vaccinations in a cost effective manner that is currently not available with the needle and syringe. "The nanopatch could also potentially eliminate needle phobia and the risk of needle stick injuries while being easy and cost-effective to administer" he said. The team includes researchers from the University of Melbourne, the Australian Animal Health lab and one of Professor Kendall"s UQ collaborators, Professor Ian Frazer of UQ"s Diamantina Institute for Cancer Immunology and Metabolic Medicine. The project is supported under the fast-tracked National Health and Medical Research Council"s H1N1 (swine flu) Medical Research Projects. The University of Queensland


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