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Sepracor's STEDESA™ (Eslicarbazepine Acetate) New Drug Application Formally Accepted For Review By The FDA
Sepracor Inc. (Nasdaq: SEPR) today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for STEDESA™ (eslicarbazepine acetate) has been accepted for filing and is now under formal review. As previously announced, the NDA for STEDESA was submitted to the FDA on March 31, 2009 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The acceptance of the filing means that the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.

GOP Senators Signal They Will Not Block Sotomayor; Full Senate Vote Expected By Aug. 7
Senate Republicans on Thursday said that they do not plan to block a vote on Supreme Court nominee Sonia Sotomayor, the Washington Post reports. Senate Judiciary Committee ranking member Jeff Sessions (R-Ala.) told Sotomayor that he would not support any effort to filibuster her nomination, meaning that she would need a simple majority of 50 votes to be confirmed. Because Democrats hold 60 votes in the Senate, Sessions" comments effectively end "any possible suspense over her fate," according to the Post (Kane et al., Washington Post, 7/17). Sessions said, "I will not support and I don"t think any member of this side will support a filibuster or any attempt to block a vote on your nomination," adding, "I look forward to you getting that vote before we recess in August." According to CQ Politics, Sessions" statement that Republicans will not filibuster "is bound to rile conservative activists," who have urged GOP senators to delay the vote to allow more time to build opposition.Sen. Lindsey Graham (R-S.C.) also signaled that he would vote for Sotomayor"s confirmation (Perine, CQ Politics, 7/16). He said, "We"ll see what your future holds, but I think it"s going to be pretty bright" (Bendavid, "Washington Wire," Wall Street Journal, 7/16). Sen. James Inhofe (R-Okla.) said that although he will not support Sotomayor"s confirmation, he will not filibuster the vote (Rushing, The Hill, 7/16). Sen. Tom Coburn (R-Okla.) told Sotomayor, "Thank you for giving us such a cordial response, and I am mightily impressed" (Washington Post, 7/17).Voting Timeline UnclearSenate Judiciary Committee Chair Patrick Leahy (D-Vt.) said he would schedule a committee vote on the nomination for July 21. It remains unclear whether committee Republicans will delay the vote until July 28, as they are permitted to do under committee rules. Sessions called the July 21 vote "unrealistic," adding that there "will be a number of questions submitted to the nominee that take some time" (CQ Politics, 7/16). A party-line vote on the nomination does not seem likely, as a number of committee Republicans have praised Sotomayor and signaled that they will vote to confirm her, the AP/Boston Globe reports (Holland, AP/Boston Globe, 7/17). The committee"s vote serves as a recommendation to the full Senate, which likely will hold its final roll-call vote on the nomination by Aug. 7 (Washington Post, 7/17). Senate Majority Leader Harry Reid (D-Nev.) on Thursday said he wants a floor vote on Sotomayor "as quickly as possible" (Brady, Roll Call, 7/16).During the hearing on Thursday, Sotomayor reiterated that she would consider each case individually and declined to state her specific views on abortion rights. In response to Coburn, she said, "Would you want a ... nominee who came in here and said, "I agree with you. This is unconstitutional," before I had a case before me?" She added, "I don"t know that that"s a justice that I can be" (Kiely/Biskupic, USA Today, 7/17). According to the New York Times, "Some observers thought they detected her tipping her hand on abortion rights when she said Supreme Court precedents required abortion restrictions to make exceptions for a woman"s health" (Savage, New York Times, 7/17).
News of the day
House Passes Spending Bill; Amendment To Block Removal Of Needle Exchange Funding Ban Defeated
The House on Friday passed a $730.5 billion bill (HR 3293) "to fund health, education and labor programs in fiscal 2010 after narrowly defeating an attempt to strip language that would lift the ban on federal needle exchange programs," in the U.S., CQ Today reports (Wolfe, 7/24). Lawmakers voted 211-218 to reject an amendment by Mark Souder (R-Ind.) that sought to keep the ban in place, the AP/Lewiston Sun Journal reports (Taylor, 7/25). The bill that passed includes a restriction against using federal funds for needle exchanges within 1,000 feet of day care centers, schools, parks, playgrounds, pools and youth centers, the Washington Post reports.
Public Health

First Novel H1N1 Influenza Cases Confirmed In Baldwin, Colbert And Dale Counties

The Alabama Department of Public Health has confirmed its first novel H1N1 influenza cases in Baldwin, Colbert and Dale counties. As of May 29, there are 85 confirmed and 9 probable cases of novel H1N1 influenza in the state. No deaths have been associated with the virus in Alabama. Counties and numbers of confirmed novel H1N1 cases which have been reported in their residents are as follows: Madison, 35; Montgomery, 8; Etowah, 7; Coffee, 6; Jefferson, 5; Shelby, 4; Lee, 4; Limestone, 2; Mobile, 2; Pike, 2; Baldwin, 2; Blount, 1; Colbert, 1; Dale, 1; and county to be determined, 5. The onset of the patients" symptoms occurred between April 20 and May 25. The ages of those affected range from 7 weeks to 45 years. Fifty-four of the state"s 85 confirmed cases are in children under 13 years of age. The median age of cases has increased to 10.5 years. Thanks to new laboratory equipment and a decline in the number of novel H1N1 influenza samples submitted, a backlog has been cleared. The symptoms of novel H1N1 influenza are similar to the symptoms of traditional influenza and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with novel H1N1 influenza. Close associates are advised to limit their contact with others for a period of seven days from the time they were exposed. The incubation period from the moment of exposure to novel H1N1 influenza until symptoms develop is two to seven days. Individuals are infectious to others one day before until seven days after symptoms develop. Persons who develop symptoms of respiratory illness should contact their medical provider. The department Web site at http://adph.org/H1N1Flu/ provides regular updates of case counts of novel H1N1 influenza within the state. Alabama Department of Public Health


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