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News Breaks
April 11, 2014
07:06 EDTAUXL, SNY, VVUSVIVUS announces avanafil clinical data presentation
VIVUS (VVUS) announced that a poster describing results of a clinical study examining onset of action of avanafil will be presented during the 29th Annual European Association of Urology Congress. STENDRA, or avanafil, is approved by the FDA in the U.S. for the treatment of erectile dysfunction. VIVUS has granted Auxilium Pharmaceuticals (AUXL) exclusive marketing rights to STENDRA in the U.S. and Canada. Auxilium is in the early stages of commercializing STENDRA in the U.S. SPEDRA is the trade name for avanafil in the European Union and is approved by the European Medicines Agency for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to Sanofi (SNY) to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia.
News For VVUS;SNY;AUXL From The Last 14 Days
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December 16, 2014
16:53 EDTAUXLAuxilium updates court findings in Actavis testosterone gel patent suit
Auxilium (AUXL) disclosed in a filing that as previously disclosed, on May 23 , Auxilium Pharmaceuticals, and FCB I LLC, as licensor of Testim, filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis (ACT) for infringement of FCBís 10 patents listed in the Orange Book as covering Testim testosterone gel. The lawsuit was filed in response to a notice letter, dated April 12, 2012, sent by Actavis Laboratories, regarding its filing with the U.S. Food and Drug Administration of an Abbreviated New Drug Application for a generic 1% testosterone gel product. This letter also stated that the ANDA contained Paragraph IV certifications with respect to the nine patents listed in the Orange Book on that date as covering Testim. The companyís lawsuit filed against Actavis initially involved those nine patents, as well as a 10th patent covering Testim that was issued on May 15, 2012 and is listed in the Orange Book. By the time that the trial commenced in September 2014, the parties had agreed to remove all but one of those patents from the litigation, with the trial focused solely on claim 3 of U.S. Patent # 7,608,607 . The trial commenced in September 2014 and closing arguments occurred in November 2014. On December 16 , the company learned that Judge Linares held that claim 3 of the Ď607 patent is invalid for obviousness. The Judge also found claim 3 invalid for derivation and improper inventorship, but he declined to rule on whether correction of inventorship would be appropriate because it would be futile in light of his ruling on obviousness. Auxilium believes that Actavis is now free to enter the market with its testosterone gel product once it obtains approval from the FDA. At this time, Auxilium is not aware of Actavis having received tentative approval or final approval from the FDA for its testosterone gel product. Auxilium is analyzing the District Courtís opinion and will explore its available options with regard to this matter.
08:58 EDTAUXLEndo a top pick for 2015, says Sterne Agee
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December 15, 2014
07:35 EDTVVUSApricus Biosciences appoints Barbara Troupin, M.D. as Chief Medical Officer
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December 11, 2014
17:04 EDTAUXLEndo registration statement relating to Auxilium declared effective by SEC
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December 9, 2014
11:19 EDTSNYSanofi reportedly ready to make acquisitions in animal medicine, Bloomberg says
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