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Stock Market & Financial Investment News

News Breaks
May 12, 2014
09:10 EDTNVS, JNJ, GSK, AGN, SNYAllergan CEO says 'rumor mill' inconsistent with company history of discreteness
Allergan CEO suggests "rumors" in the market regarding the company and its potential M&A plans may start outside of the company and may come from those that have an "interest" in spreading such rumors. Note that Bloomberg previously reported, citing sources, that Allergan has so far been rejected by companies including Sanofi (SNY) and Johnson & Johnson (JNJ) and the news service quoted one source as having said that Allergan also contacted GlaxoSmithKline (GSK) and Novartis (NVS).
News For AGN;JNJ;SNY;GSK;NVS From The Last 14 Days
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February 17, 2015
17:02 EDTAGNSoros Fund Management gives quarterly update on stakes
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16:29 EDTJNJ Boston Scientific announces settltement of merger agreement lawsuit
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13:52 EDTAGNEarnings Preview: Actavis near 52-week high ahead of Q4 earnings report
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11:38 EDTSNYGenzyme reports publication of ENGAGE registration study results
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07:38 EDTGSKGlaxo replaces head of struggling U.S. drug unit, Bloomberg reports
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07:04 EDTJNJGTx names Robert Wills as executive chairman
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February 13, 2015
11:31 EDTNVSNovartis says heart failure medicine LCZ696 granted FDA piority review
Novartis announced that the U.S. FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction. The designation accelerates the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition[4]. For LCZ696 this reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015. The New Drug Application was submitted under the agency's Fast Track program and is based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure, which showed LCZ696 was superior to ACE-inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. Patients' reports of how well they felt were significantly better with LCZ696 than enalapril, whilst maintaining an acceptable safety profile. In the EU the Committee for Medicinal Products for Human Use has granted accelerated assessment to LCZ696.
10:00 EDTGSKOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Ametek (AME) upgraded to Outperform at RW Baird... Ascena Retail (ASNA) upgraded to Buy from Hold at KeyBanc... Cabela's (CAB) upgraded to Buy from Neutral at DA Davidson... CoreSite Realty (COR) upgraded to Overweight from Equal Weight at Stephens... Cytokinetics (CYTK) upgraded to Overweight from Neutral at Piper Jaffray... DTS, Inc. (DTSI) upgraded to Outperform at Cowen... Dr Pepper Snapple (DPS) upgraded to Market Perform from Underperform at Wells Fargo... Elizabeth Arden (RDEN) upgraded to Outperform from Market Perform at BMO Capital... EnLink Midstream (ENLC) upgraded to Buy from Hold at Wunderlich... GlaxoSmithKline (GSK) upgraded to Buy from Sell at UBS... Great-West Lifeco (GWLIF) upgraded to Buy from Hold at TD Securities... Himax (HIMX) upgraded to Buy from Neutral at Chardan... Mallinckrodt (MNK) upgraded to Overweight from Neutral at JPMorgan... Medical Properties upgraded to Outperform from Sector Perform at RBC Capital... Microchip (MCHP) upgraded to Buy from Hold at Drexel Hamilton... Orbitz (OWW) upgraded to Neutral from Sell at Goldman... Plains GP Holdings (PAGP) upgraded to Overweight from Equal Weight at Stephens... SanDisk (SNDK) upgraded to Buy from Hold at Drexel Hamilton... SkyWest (SKYW) upgraded to Buy from Hold at Deutsche Bank... Stage Stores (SSI) upgraded at Sterne Agee... Tractor Supply (TSCO) upgraded to Buy from Hold at Argus... Valero (VLO) upgraded to Conviction Buy from Neutral at Goldman... Watsco (WSO) upgraded to Overweight from Equal Weight at Stephens.
08:23 EDTJNJ, NVS, GSKPiper Jaffray biotech/healthcare analysts hold analyst/industry conference call
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08:19 EDTGSKAckman noncommittal on McDonald's rumors, Bloomberg reports
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06:33 EDTGSKGlaxoSmithKline upgraded to Buy from Sell at UBS
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05:09 EDTJNJStocks with implied volatility movement; JNJ NUGT
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February 12, 2015
16:20 EDTSNYGenzyme announces data from Phase 1b study for Niemann-Pick Type B
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16:02 EDTJNJOptions Update; February 12, 2015
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15:12 EDTJNJJ&J Remicade appeal process could take years to resolve, says Wells Fargo
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15:00 EDTJNJEPIRUS gains after J&J patent for Remicade rejected by USPTO
Shares of small-cap pharmaceutical company EPIRUS Biopharmaceuticals (EPRS) are rising in afternoon trading after Johnson & Johnson (JNJ) confirmed earlier that the U.S. Patent and Trademark Office issued a final rejection of patent '471 patent relating to infliximab, which is sold with the trade name Remicade. EPIRUS is focused on the research, development, manufacturing and commercialization of biosimilar therapeutics and its pipeline includes BOW015, a biosimilar version of infliximab. In afternoon trading, shares of EPIRUS rose 83c, or 14%, to $6.72.
14:36 EDTJNJJ&J confirms USPTO issues final rejection of Remicade '471 patent
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12:30 EDTJNJJohnson & Johnson Remicade patent rejected by USPTO, says Goldman
Goldman Sachs notes the United States Patent and Trademark Office completed the re-examination of Johnson & Johnson's Remicade patent and issued a rejection. Goldman now sees increased risk of a biosimilar version of Remicade launching earlier than expected, possibly in 2015. It keeps a Sell rating on the stock with a $96 price target. Shares of J&J are down 2% to $98.70 in midday trading.
12:19 EDTJNJJ&J Remicade patent rejected in re-exam by USPTO, Bloomberg reports
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08:52 EDTSNYSanofi's Genzyme reports Phase 3 results for Cerdelga
Genzyme, a Sanofi company, reported extension study data from its Phase 3 ENGAGE and ENCORE studies of Cerdelga, or eliglustat, a first-line oral therapy approved by the FDA and the European Commission for the treatment of certain adults with Gaucher disease type 1. Both extension studies demonstrated continued stability and/or improvements across established end points and published therapeutic treatment goals. ENGAGE is a phase 3, randomized, double-blind, placebo-controlled, multi-center tudy to investigate the efficacy and safety of eliglustat in adults with gaucher disease type 1. After 18 months, in the primary analysis period, improvements were seen across the following endpoints after 9 months on cerdelga: spleen size, platelet count, hemoglobin concentration, and liver volume. In the 9 month extension phase, patients who switched from placebo to eliglustat showed improvements similar to the eliglustat-treated patients during the primary analysis while the eliglustat-treated patients continued to show improvements during the 9 month extension period. There were no treatment-related discontinuations. ENCORE is a phase 3, randomized, controlled, open-label non-inferiority study comparing eliglustat to imiglucerase in gaucher disease type 1 patients stabilized on enzyme replacement therapy. After 24-months, the study, which met the primary analysis criteria for non-inferiority to imiglucerase, had a composite endpoint of each of the following parameters: spleen volume, hemoglobin concentration, platelet counts, and liver volume at 12 months. During the 12-month extension period, the patients who crossed over to eliglustat treatment from imiglucerase remained stable. Patients treated with eliglustat for 24 months also maintained stability of clinical parameters during the extension period. The most common adverse reactions -- ≥10% -- in the primary analysis periods of ENGAGE and ENCORE were fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. In both extension studies the majority of adverse reactions with Cerdelga were mild and transient, and consistent with those in the primary analysis periods. Most patients in both of the Phase 3 studies continue to receive Cerdelga in longer term extension periods. The majority of patients are now in their 4th or 5th year of treatment.
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