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Stock Market & Financial Investment News

News For A;R;SPW;SNY;WBMD;CVS;ESV;TER;BSX From The Last 14 Days
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March 27, 2015
14:04 EDTSNYRegeneron price target raised to $500 from $450 at Argus
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March 26, 2015
11:13 EDTSNYBofA/Merrill European pharma analyst holds an analyst/industry conference call
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05:29 EDTSNYGenzyme reports Cerdelga data shows effectiveness in treating Gaucher disease
Genzyme, a Sanofi company, announced the publication of results from the ENCORE study exploring Cerdelga as a maintenance therapy suitable for adult patients who had reached pre-specific treatment goals on enzyme replacement therapy, or ERT, in the March 26 online issue of The Lancet. ENCORE is a randomized, multinational, Phase 3, open-label, non-inferiority study designed to determine whether patients with Gaucher disease type 1 who had been stabilized after 3 or more years of ERT infusions would remain stable after switching to Cerdelga, a novel, oral, selective inhibitor of glucosylceramide synthase. Eligible patients were randomized 2:1 to receive either oral Cerdelga or ERT with Cerezyme over a period of 12 months. The composite primary efficacy endpoint was the percentage of patients whose hematologic parameters and organ volumes remained stable, using the following stability criteria established for patients with Gaucher disease type 1 on maintenance therapy with Cerezyme: Hemoglobin concentration that did not decrease more than 1.5 g/dL; Platelet count that did not decrease more than 25%; Spleen volume that did not increase more than 25%; Liver volume that did not increase more than 20%. After 12 months, 85% of patients receiving Cerdelga and 94% of patients receiving Cerezyme met the composite endpoint of stability in all four of these measures. The difference between the two treatments was within the pre-specified margins. The principal secondary endpoints were stability with respect to the individual components of the primary endpoint. At least 93% of Cerdelga patients remained stable with respect to hemoglobin concentration, platelet count, spleen volume, and liver volume after 12 months of treatment. Additional endpoints evaluated bone disease, Gaucher disease severity, quality-of-life and Gaucher-disease associated biomarkers.
March 25, 2015
16:37 EDTCVSSpecialists On Call names Hammad Shah as CEO
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12:17 EDTSNYSanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine
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11:45 EDTCVSLeerink healthcare tech/pharma analysts hold analyst/industry conference call
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March 24, 2015
16:06 EDTBSXBoston Scientific announces first commercial procedures with Watchman Device
This week, three patients in the U.S. received the first implants of the Boston Scientific Watchman Left Atrial Appendage Closure, or LAAC, Device. The WATCHMAN Device offers a novel stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation, or AF, who are seeking an alternative to long-term warfarin therapy. The Watchman Device received FDA approval on Friday, March 13. The first Watchman Device procedures in the U.S. were performed by Shephal K. Doshi, M.D., director of Cardiac Electrophysiology and Pacing at Saint John's Health Center in Santa Monica, CA, and Saibal Kar, M.D., director of the Cardiovascular Intervention Center Research at Cedars-Sinai Hospital in Los Angeles, CA.
09:10 EDTADako announces collaboration agreement with Amgen
Dako, an Agilent Technologies (A) company, announced a new Master Collaboration Agreement with Amgen (AMGN). The expanded collaboration will allow both companies to benefit from knowledge-sharing within the field of drug-diagnostic research and development in general, and in relation to companion diagnostic products in particular. The financial details of the agreement were not disclosed.
March 23, 2015
16:19 EDTBSXBoston Scientific leads funding round for InterVene
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09:45 EDTSNYUBS to hold a field trip
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08:01 EDTRRyder price target raised to $130 from $117 at FBR Capital
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March 20, 2015
10:00 EDTBSXOn The Fly: Analyst Initiation Summary
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08:32 EDTBSXBoston Scientific has a conference call hosted by JPMorgan
JPMorgan Analyst Weinstein will host a conference call with CEO Mike Mahoney on March 27 at 11 am.
06:44 EDTBSXBoston Scientific initiated with an Outperform at Raymond James
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March 19, 2015
07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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08:31 EDTAAgilent names president and COO Mike McMullen as CEO
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05:39 EDTBSXSt. Jude Medical downgraded to Market Perform from Outperform at Wells Fargo
Wells Fargo downgraded St. Jude Medical (STJ) to Market Perform saying competitive pressures will drive 2015 market share losses in the company's cardiac rhythm management business, which represents 50% of total sales. Wells believes the launch of CardioMEMS will not be strong enough to offset the headwinds in CRM unit. The firm thinks Boston Scientific's (BSX) earlier than expected approval for its next generation subcutaneous implantable cardioverter-defibrillator called Emblem will drive share gains against St. Jude and Medtronic (MDT) in the single chamber ICD market. Wells cut its price target range for St. Jude shares to $69-$70 from $73-$74. The medical technology company closed yesterday down $2.01 to $65.45.
March 17, 2015
16:13 EDTBSXBoston Scientific announces FDA, CE Mark approval of EMBLEM S-ICD system
Boston Scientific has received FDA and CE Mark approval of the EMBLEM Subcutaneous Implantable Defibrillator, or S-ICD, system. The EMBLEM S-ICD System is a treatment option that provides protection for patients at risk of sudden cardiac arrest, yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators. A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May and subsequent U.S. launch planned for the third quarter of 2015.
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
06:31 EDTCVSStudies find Gilead's hepatitis C drugs cost effective, Reuters says
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05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink
March 16, 2015
13:16 EDTBSXAnalysts upbeat on results of Edwards' Sapien 3 data
The shares of Edwards Lifesciences (EW) are rising after the company released data on its Sapien 3 transcathter aortic valve over the weekend. In notes to investors today, a number of analysts were upbeat on the data. BACKGROUND: Edwards yesterday announced that high- and intermediate-risk patients treated with Sapien 3 demonstrated lower mortality rates than patients treated with previous transcathter aortic valves, or TAVR, made by the company. The patients also had excellent clinical outcomes in the other primary endpoints of stroke and paravalvular regurgitation, the company stated. Meanwhile, a five year study of patients treated with the first generation SAPIEN device showed that the patients had equivalent outcomes to traditional open-heart surgery, and no structural valve deterioration requiring intervention, the company stated. ANALYST REACTION: Edwards' Sapien 3 data was impressive, as the device showed one of the lowest stroke and mortality rates of any major TAVR study so far, Bernstein analyst Derrick Sung wrote in a note to investors earlier today. Data presented by Edwards and other companies at the American College of Cardiology, or ACC, conference this weekend caused investors and the medical community to become more optimistic about the potential for TAVR devices to replace surgical valves, Sung stated. The analyst wrote that he continues to believe that investors are underestimating the potential size of the TAVR market. Also upbeat on Edwards' data was Wells Fargo, which wrote that the data exceeded high expectations and could pressure the FDA to approve Sapien 3 for intermediate risk patients earlier than Edwards' guidance of late 2016. WHAT'S NOTABLE: Analysts were also upbeat on data reported by other companies at the ACC conference. Medtronic's (MDT) data suggested that its CoreValve Evolut-R product may be as effective as Edwards' Sapien 3, Bernstein's Sung stated. The FDA appears to have allowed Boston Scientific's (BSX) left atrial appendage closure, Watchman, to be provided to more patients than expected, research firm Stifel believes. Meanwhile, St. Jude's (STJ) CardioMEMS device yielded "impressive" mortality data, the firm added. Stifel kept Buy ratings on both Medtronic and St. Jude. PRICE ACTION: In early afternoon trading, Edwards Lifesciences climbed 9% to $147.64, Boston Scientific advanced 4% to $17.27, St. Jude added 2% to $67.55, and Medtronic rose 1.3% to $77.50.
09:22 EDTBSXOn The Fly: Pre-market Movers
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08:23 EDTSNYPCSK9 data continues to impress, says Leerink
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07:25 EDTBSXBoston Scientific Watchman indication 'very favorable,' says Bernstein
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07:16 EDTSNYRegeneron Sanofi dupilumab drug can generate $6B+ in revenue, says Bernstein
Bernstein believes that dupilumab, a drug made by Regeneron and Sanofi, has shown strong efficacy in patients with severe atopic dermatitis. The firm notes that the drug is currently in pivotal trials involving patients with severe levels of other common diseases. The firm thinks the drug can generate $1.5B of revenue by 2018 and $3.8B by 2020. Bernstein keeps a $500 price target and Outperform rating on Regeneron.
06:40 EDTSNYPCSK9 studies show potential improvement in heart health, WSJ says
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