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Incyte Provides Update On Special Protocol Assessment For INCB18424 As A New Treatment For Myelofibrosis
Incyte Corporation (Nasdaq:INCY) announced that based on recent input from the U.S. Food and Drug Administration (FDA) regarding Incyte"s request for a Special Protocol Assessment (SPA) for INCB18424 for patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF), it is clear that the most appropriate single primary endpoint for Incyte"s U.S. Phase III trial is the proportion of treated patients achieving a 35% reduction in spleen volume as compared to patients receiving placebo.

Senate Judiciary Committee Postpones Votes On Two Federal Court Nominees
Republicans on the Senate Judiciary Committee delayed a confirmation vote on President Obama"s nominees for federal court positions until after the Memorial Day recess, Roll Call reports. David Hamilton, a district court judge in southern Indiana, is nominated for the 7th U.S. Circuit Court of Appeals, and Andre Davis is nominated for the 4th U.S. Circuit Court of Appeals (Brady, Roll Call, 5/21). Committee ranking member Jeff Sessions (R-Ala.) said, "Our members are concerned" about Hamilton, adding that Hamilton "has had a number of troubling rulings dealing with a series of prayers at the Indiana Legislature." Hamilton in 2005 ruled that prayers used to open the Legislature must be nonsectarian. Sessions said he also is concerned about Hamilton"s ruling to prohibit religious displays in public buildings. Committee Chair Patrick Leahy (D-Vt.) defended Hamilton"s record. Leahy said, "He is, after all, the son of a minister, and he believes very strongly in the constitutional separation of church and state" (Stern, Bloomberg/Philadelphia Inquirer, 5/22). Leahy added that Hamilton "ought to be commended rather than obstructed or delayed." Meanwhile, the committee is awaiting Obama"s nominee to replace Justice David Souter on the Supreme Court. The nomination could further complicate consideration of Hamilton and Davis, as it is expected to occupy the panel through the summer (Roll Call, 5/21).
News of the day
Leading Scientists And Scholars Urge Action On Climate Issues
In an open letter addressed to President Barack Obama and the United States Congress, twenty leading scientists and scholars assert that the currently stated objectives in limiting the climatic disruption are grossly inadequate and urge the nation"s leadership to take clear leadership towards meet the objectives of the 1992 Framework Convention on Climate Change, steps necessary to avert a "global climatic catastrophe".
Oncology

SRI International To Screen Drugs That Fight 2009 H1N1 Influenza A

SRI International, an independent, nonprofit research and development organization, announced today that it will screen a library of well-characterized drugs against the 2009 H1N1 influenza A virus, previously known as "swine flu." The work will be performed under a re contract from the Division of Microbiology and Infectious Diseases (DMID) in the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. There is currently only one class of antiviral drugs, the neuraminidase inhibitors, available to treat this H1N1 infection. Identifying drugs from other chemical and mechanistic classes could provide more effective alternatives to current therapies and make it easier to provide sufficient quantities of drugs to a broad population, should the need arise. The development of new treatments may be expedited by screening drugs that have already well-characterized safety and toxicity profiles. "SRI has expertise in screening new and approved drugs, including the development of novel uses for antibiotics and screening a library of licensed drugs to find compounds that show efficacy against biothreat agents. SRI appreciates the opportunity to apply its knowledge and skills to screening drugs against H1N1 flu and contributing to the overall understanding of the virus," said Amy Shurtleff, Ph.D., a senior virologist in SRI International"s Biosciences Division, who will lead this screening program. Although the number of new 2009 H1N1 influenza A virus cases appears to be slowing worldwide, viruses are unpredictable. In particular, it is not known how this new virus will behave when the seasonal flu season returns this fall and in subsequent years. Scientists are looking at the Southern Hemisphere now, where the flu season will begin soon, for any signs of changes in the H1N1 virus and how humans respond to the infection. SRI has a long and successful history of drug discovery and development, which includes both screening of licensed drugs and finding and studying new chemical and biological therapeutics and vaccines. The virus will be handled in compliance with all guidelines prescribed by the Centers for Disease Control and Prevention (CDC) for handling this strain of influenza. SRI researchers will culture cell lines and study H1N1 virus growth under well-controlled conditions. Next, they will begin testing the first round of drugs. Assuming that some drugs show worthwhile efficacy and potency, SRI will help develop a plan for preclinical and clinical evaluation and regulatory approval. SRI International *See our Map Of H1N1 Outbreaks *See our Mexico Swine Flu Blog


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