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Stock Market & Financial Investment News

News Breaks
April 16, 2014
10:27 EDTENDPEndo International says AMS unit received FDA warning letter
In a regulatory filing, Endo International disclosed that as previously reported in Endo Health Solutions's Form 10-K filed with the SEC on March 3, in February 2014, the United States FDA conducted an inspection of the Minnetonka, Minnesota facility of American Medical Systems, AMS, a subsidiary of Endo International. Following such inspection, the FDA issued three observations on a Form 483 Notice of Inspectional Observations dated February 24. These observations, previously self-identified by AMS, were being addressed through a corrective action plan which AMS originally expected to complete beyond 2015. On April 14, AMS received a Warning Letter from the FDA, dated April 10. The Warning Letter relates to the same matters as identified in the Form 483 Notice. Specifically, the Warning Letter discusses observations related to process validation, risk analysis and corrective and preventive action procedures. The letter states that the corrective actions which AMS reviewed with the FDA on March 20, 2014 appear to be adequate, but it goes on to state that many of the actions have not yet been completed and will need to be validated in a follow-up inspection. AMS has 15 days to respond to the Warning Letter. AMS expects only limited related impact to its business at this time. The Minnetonka, Minnesota facility will continue to manufacture and ship products while AMS works with the FDA.
News For ENDP From The Last 14 Days
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November 24, 2014
07:57 EDTENDPPerrigo confirms first to file patent challenge for generic version of Aveed
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07:11 EDTENDPTrimel announces license agreement with Endo for NATESTO
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07:02 EDTENDPEndo acquires rights to Natesto testosterone nasal gel
Endo announced the acquisition of rights to Natesto, the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel BioPharma SRL, a wholly-owned subsidiary of Trimel Pharmaceuticals Corporatio. Natesto™ was approved by the FDA in May of 2014. Under the terms of the agreement Trimel will receive an upfront payment of $25M and could receive additional payments upon the achievement of certain regulatory and sales milestones. Additionally, Trimel will be responsible for the manufacture and supply of Natesto and Endo will pay a tiered supply price for the product. Endo expects the transaction to close in early 2015. Under the terms of the agreement, Endo receives sole and exclusive commercial rights to the Natesto product in the US and Mexico. In addition, Endo will collaborate on all regulatory and clinical development activities in coordination with Trimel.
November 20, 2014
07:33 EDTENDPEndo launches generic version of Hoffmann-La Roche's Valcyte
Endo's Qualitest subsidiary has launched a generic version of Hoffmann-La Roche's Valcyte. For the 12 months ending September 30, Valcyte had total U.S. sales of approximately $440M, according to IMS Health data.
November 19, 2014
10:21 EDTENDPHigh option volume stocks
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07:33 EDTENDPEndo, Auxilium receive early termination of HSR waiting period for deal
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November 14, 2014
09:38 EDTENDPJANA Partners gives quarterly update on stakes
NEW STAKES: AMD (AMD), AECOM Technology (ACM), Alibaba (BABA), McDonald's (MCD), Amgen (AMGN), Gaming and Leisure Properties (GLPI), Iron Mountain (IRM), iRobot (IRBT), Seadrill Partners (SDLP), Valeant (VRX). INCREASED STAKES: eBay (EBAY), Charter (CHTR), Groupon (GRPN), HD Supply (HDS), Hertz (HTZ). DECREASED STAKES: Apache (APA). LIQUIDATED STAKES: CBS (CBS), Endo (ENDP), FMC Corporation (FMC), SeaWorld (SEAS), SunEdison (SUNE).
November 10, 2014
08:17 EDTENDPEndo receives final approval for generic version of Valcyte
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