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Stock Market & Financial Investment News

News Breaks
April 25, 2014
11:02 EDTMRK, SNYEMA backs new indication for Sanofi's Gardasil, Merck's Silgard
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for Sanofi's (SNY) medicinal product Gardasil. The CHMP adopted a new indication of: "Gardasil is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions, premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus types and genital wartscausally related to specific HPV types." The CHMP also adopted a positive opinion recommending a variation to the terms of the marketing authorization for Merck Sharp & Dohme's (MRK) Silgard. The CHMP adopted a new indication of: "Silgard is a vaccine for use from the age of 9 years for the prevention of premalignant genital lesions, premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus types and genital warts causally related to specific HPV types."
News For SNY;MRK From The Last 14 Days
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April 28, 2015
08:27 EDTMRKMerck HCV results appear inferior, says Bernstein
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07:59 EDTMRKMerck HCV data supports NDA filing, says SunTrust
SunTrust believes that Merck's C-EDGE & C-SURFER efficacy data at EASL indicates that the company's HCV treatment is competitive with Gilead's (GILD) single pill dose and superior to AbbVie's (ABBV) Viekira Pak. The firm says the data supports Merck's imminent NDA filing with breakthrough designation, potentially enabling a 2H15 launch. It keeps a $72 price target and Buy rating on the shares.
07:03 EDTMRKMerck sees FY15 EPS $3.35-$3.48, consensus $3.37
Sees FY15 revenue $38.3B-$39.8B, consensus $39.2B.
07:02 EDTMRKMerck reports Q1 EPS 85c, consensus 74c
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05:30 EDTSNYGenzyme says FDA grants fast track designation for development of GZ/SAR402671
Genzyme, a Sanofi company, announced that the FDA has granted Fast Track designation for the development of GZ/SAR402671, a new investigational oral substrate reduction therapy for the treatment of Fabry disease. FDAs Fast Track Drug Development Program is designed to facilitate frequent interactions with the FDA review team to expedite the clinical development and review of a New Drug Application, or NDA, for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs for such disease or conditions. It also provides the opportunity to submit sections of an NDA on a rolling basis before a sponsor submits the complete application. Genzyme is currently enrolling patients in its Phase 2a trial of GZ/SAR402671, and plans to enroll nine treatment-nave male adult patients with Fabry disease in this international, multicenter study.
April 27, 2015
18:56 EDTMRKOn The Fly: After Hours Movers
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18:32 EDTMRKMerck announces publication of pivotal data from Zerbaxa Phase 3 clinical study
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17:13 EDTMRKMerck announces Januvia study achieved primary endpoint
Merck announced that the trial evaluating cardiovascular outcomes with Sitagliptin, or TECOS, of Merck's DPP-4 inhibitor, Januvia, or sitagliptin, achieved its primary endpoint of non-inferiority for the composite cardiovascular endpoint. Among secondary endpoints, there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo. The complete results of TECOS will be presented on June 8 at the Scientific Sessions of the American Diabetes Association. TECOS was an event-driven trial conducted in adults with type 2 diabetes and a history of cardiovascular disease. The study was designed to assess the CV safety of long-term treatment with Januvia as part of usual diabetes care compared with usual care without Januvia. The primary endpoint was the composite of time to the first of any of the following confirmed events: cardiovascular-related death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina requiring hospitalization. TECOS enrolled 14,724 participants from 38 countries between December 2008 and July 2012. The median patient follow-up was approximately three years.
15:04 EDTMRKNotable companies reporting before tomorrow's open
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13:43 EDTMRKEarnings Watch: Merck shares lower by about 5.6% since last earnings report
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09:37 EDTMRKBarclays healthcare analysts hold an analyst/industry conference call
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06:19 EDTMRK, SNYPharmceutical companies buy drugs and raises prices, WSJ reports
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April 24, 2015
07:58 EDTMRKMerck May weekly volatility elevated into Q1 and outlook
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05:35 EDTMRKMerck Phase 3 C-EDGE program shows high sustained virologic responses
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April 23, 2015
16:39 EDTMRKACETO subsidiary to launch Timolol Maleate Ophthalmic Solution
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05:40 EDTMRKMerck announces results from C-SURFER Phase 2/3 study
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April 22, 2015
10:02 EDTSNYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Alcatel-Lucent (ALU) upgraded on post-merger outlook at Bernstein... Amazon.com (AMZN) upgraded to Buy, price target raised to $450 at Monness Crespi... BNP Paribas (BNPQY) upgraded to Overweight from Equal Weight at Morgan Stanley... Dolby (DLB) upgraded to Overweight from Neutral at JPMorgan... First Defiance (FDEF) upgraded to Outperform from Market Perform at Raymond James... Gran Tierra (GTE) upgraded to Buy from Neutral at Dundee... Grupo Aval (AVAL) upgraded to Buy from Neutral at Goldman... Manhattan Associates (MANH) upgraded to Buy from Hold at Benchmark Co.... Marriott (MAR) upgraded to Buy from Neutral at MKM Partners... Masco (MAS) upgraded to Outperform from Market Perform at FBR Capital... Nokia (NOK) upgraded on post-merger outlook at Bernstein... Packaging Corp. (PKG) upgraded to Buy from Hold at Deutsche Bank... Rayonier (RYN) upgraded to Sector Perform from Underperform at RBC Capital... Rogers Communications (RCI) upgraded to Buy from Neutral at BofA/Merrill... Sanofi (SNY) upgraded to Neutral from Sell at Citigroup... Select Comfort (SCSS) upgraded to Outperform from Neutral at Wedbush... UniCredit (UNCFF) upgraded to Buy from Sell at Berenberg... Zions Bancorp (ZION) upgraded to Outperform from Market Perform at FBR Capital.
08:18 EDTMRKOrganovo enters into a collaboration agreement with Merck Sharp and Dohme
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07:07 EDTSNYEuropean Association for the Study of the Liver to hold annual meeting
50th Annual Meeting of EASL will be held in Vienna, Austria on April 22-26.
06:52 EDTSNYSanofi upgraded to Neutral from Sell at Citigroup
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