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News Breaks
January 28, 2013
16:25 EDTSNTS, MYLSantarus discloses lawsuit against Mylan for patent infringement
Santarus disclosed in a regulatory filing that on January 28, Santarus (SNTS) filed a lawsuit in the U.S. District Court for the District of Delaware against Mylan (MYL) and Mylan Pharmaceuticals for infringement of the patents listed in the Orange Book for Santarusí prescription product, Fenoglide tablets, 40 mg and 120 mg. Veloxis Pharmaceuticals A/S, licensor of the patents, is joined in the litigation as a co-plaintiff. The lawsuit is in response to an Abbreviated New Drug Application filed by Mylan with the U.S. FDA regarding Mylanís intent to market generic versions of Fenoglide prior to the 2024 expiration of the two listed patents. The lawsuit was commenced within the 45 days required to automatically stay, or bar, the FDA from approving Mylanís ANDA for 30 months or until a district court decision that is adverse to the plaintiffs, whichever may occur earlier.
News For SNTS;MYL From The Last 14 Days
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January 29, 2015
11:19 EDTMYLMylan shareholders approve acquisition of Abbott's generics business
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09:13 EDTMYLAbbott sees 6% negative impact to FY sales from forex
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January 28, 2015
11:34 EDTMYLEC clears Abbott sale of non-U.S. EPD-DM business to Mylan, with conditions
The European Commission has cleared under the EU Merger Regulation the proposed acquisition of Abbott Laboratories' (ABT) Non-U.S. Developed Markets Specialty and Branded Generics Business, or EPD-DM, by Mylan (MYL). The decision is conditional upon the divestment of a number of Mylan's businesses in Germany, the United Kingdom, France, Ireland and Italy. The Commission had concerns that the transaction, as initially notified, would have reduced competition on the market for several medicines. The commitments offered by Mylan address these concerns, the EC said.
January 26, 2015
11:00 EDTMYLMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
January 20, 2015
14:37 EDTMYLTeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTMYLMylan says continues to believe '808 patent is 'invalid'
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10:40 EDTMYLMomenta Pharma sinks after Supreme Court rules on Copaxone
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