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News Breaks
June 25, 2014
05:32 EDTNVS, SHPG, MYL, ACTShire says New Jersey court found Vyvanse patents infringed
Shire announces that Judge Stanley Chesler of the U.S. District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse were both infringed and valid. The ruling prevents the five pharmaceutical manufacturers who have filed Abbreviated New Drug Applications from launching generic versions of Vyvanse until the earlier of either a successful appeal to the U.S. Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA Defendants must overturn the court's rulings for each of the 18 patent claims, Shire said. The court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. Shire's lawsuit is against the five ANDA defendants that filed ANDAs with the FDA seeking to market generic versions of Vyvanse. The defendants are Actavis (ACT), Amneal Pharmaceuticals, Mylan (MYL), Roxane Laboratories and Novartis' (NVS) Sandoz.
News For SHPG;ACT;MYL;NVS From The Last 14 Days
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November 18, 2015
08:22 EDTMYLMylan resinstated with an Overweight at JPMorgan
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08:11 EDTNVSIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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07:43 EDTNVSJefferies to hold a conference
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06:02 EDTMYLPerrigo upgraded to Buy from Neutral at B. Riley
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November 17, 2015
16:38 EDTNVSAduro Biotech to delay filing 10-Q
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10:11 EDTMYLOptions with decreasing implied volatility
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10:00 EDTSHPGOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: CF Industries (CF) upgraded to Positive at Susquehanna... ExlService (EXLS) upgraded to Buy from Neutral at BofA/Merrill... Fitbit (FIT) upgraded to Buy at BofA/Merrill... Forward Air (FWRD) upgraded to Outperform at Baird... HD Supply (HDS) upgraded to Positive from Neutral at Susquehanna... Hannover Re (HVRRY) upgraded to Overweight from Underweight at JPMorgan... Moody's (MCO) upgraded to Buy from Neutral at UBS... PRA Group (PRAA) upgraded to Strong Buy from Market Perform at Raymond James... Plum Creek Timber (PCL) upgraded to Outperform from Sector Perform at RBC Capital... Shire (SHPG) upgraded to Outperform from Market Perform at Leerink... Yandex (YNDX) upgraded to Overweight from Equal Weight at Morgan Stanley... Zayo Group (ZAYO) upgraded to Buy from Neutral at MoffettNathanson.
07:34 EDTMYLMylan launches Almotriptan Tablets USP in the U.S.
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07:34 EDTNVSOphthotech to hold a conference call
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06:08 EDTNVSRoche subsidiary to participate in Ophthotech and Novartis agreement
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05:24 EDTNVSNovartis announces Phase III FLAME head-to-head trial met primary endpoint
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November 16, 2015
16:53 EDTSHPGPaulson reduced stake in Valeant
Paulson & Co. gave a quarterly update on its stakes in a filing this afternoon. NEW STAKES: Perrigo (PRGO), CIT Group (CIT), Precision Castparts (PCP), Cameron (CAM), and Altera (ALTR). INCREASED STAKES: Teva (TEVA), Post Holdings (POST), Starwood Hotels (HOT), LivaNova (LIVN), and Synergy Pharmaceuticals (SGYP). DECREASED STAKES: Valeant (VRX), Shire (SHPG), Whiting Petroleum (WLL), Computer Sciences (CSC), and Oasis Petroleum (OAS). LIQUIDATED STAKES: Houghton Mifflin Harcourt (HMHC), Broadcom (BRCM), and Sprint (S).
16:18 EDTSHPGShire upgraded to Outperform, price target raised to $239 at Leerink
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16:02 EDTSHPGShire upgraded to Outperform from Market Perform at Leerink
11:42 EDTMYLMylan announces $1B share repurchase plan
Mylan announced that the Board of Directors of Mylan has authorized share repurchases by the company of its ordinary shares in an amount up to $1B, either in the open market through privately-negotiated transactions or in one or more self tender offers. The repurchase program does not obligate the company to acquire any particular amount of ordinary shares. The authorization expires on August 27, 2016.
09:59 EDTSHPGOmega bought Valeant in Q3, sold some SuneEdison
Leon Cooperman's Omega Advisors gave a quarterly update on its stakes in a filing this morning, disclosing its positions as of September 30. NEW STAKES: Pfizer (PFE), Valeant (VRX) Walgreens Boots Alliance (WBA), TerraForm Global (GLBL), Cigna (CI). INCREASED STAKES: Google Class A (GOOGL), Facebook (FB), Delta Air Lines (DAL). DECREASED STAKES: SunEdison (SUNE), Shire (SHPG), Citi (C), KAR Auction (KAR), LyondellBasell (LYB). LIQUIDATED STAKES: McKesson (MCK), 21st Century Fox (FOXA), General Motors (GM), QEP Resources (QEP), eBay (EBAY).
07:40 EDTMYLMylan launches generic Viramune XR ER tablets, 100mg
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07:32 EDTMYLMylan launches generic GLUCOTROL XL tablets
Mylan (MYL) announced the U.S. launch of Glipizide Extended-release Tablets, 5 mg and 10 mg, the generic version of Pfizer's (PFE) GLUCOTROL XL. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide Extended-release Tablets, 5 mg, and 10 mg, had U.S. sales of approximately $70.7 million for the 12 months ending September 30, 2015, according to IMS Health.
07:16 EDTMYLHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).
06:01 EDTSHPGSynergy Pharmaceuticals appoints Gary Sender as CFO
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