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News Breaks
April 11, 2014
07:06 EDTAUXL, VVUS, SNYVIVUS 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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July 31, 2014
06:41 EDTAUXLAuxilium reports XIAFLEX milestone, triggers $10M payment
Auxilium Pharmaceuticals announced that the company will receive a $10M regulatory milestone payment from its partner Asahi Kasei Pharma Corporation. The payment is due because of the successful submission of a regulatory application to the Japanese Pharmaceutical and Medical Device Agency, or PMDA, for XIAFLEX for the treatment of Dupuytren's contracture, or DC. The review by PMDA is expected to be completed by mid-2015. XIAFLEX is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
05:56 EDTSNYSanofi reports Q2 business net income up 13% to EUR 1.54B
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July 30, 2014
16:31 EDTSNYRegeneron, Sanofi announce plan to use priority review voucher for alirocumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the companies intend to use a FDA rare pediatric disease priority review voucher in connection with the Biologics License Application, or BLA, submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, purchased the voucher from BioMarin GALNS, a direct, wholly-owned subsidiary of BioMarin Pharmaceutical (BMRN), which had received it through the FDA's rare pediatric disease priority review voucher program. Sanofi and Regeneron will equally share the purchase price of $67.5M. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.
12:33 EDTSNYRegeneron, Sanofi likely to file alirocumab BLA this year, says Piper Jaffray
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08:08 EDTSNYSanofi and Regeneron report positive Phase 2 results of alirocumab
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July 28, 2014
09:02 EDTSNYSanofi, InnerWorkings sign global marketing partnership
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July 21, 2014
07:11 EDTSNYInternational Society of DNA Vaccines to hold a conference
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