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March 19, 2013
05:55 EDTARTC, ARTC, ARTC, ARTC, ARTC, MDT, MDT, MDT, MDT, MDT, MGLN, MGLN, MGLN, MGLN, MGLN, MAKO, MAKO, MAKO, MAKO, MAKO, KYO, KYO, KYO, KYO, KYO, ECL, ECL, ECL, ECL, ECL, COV, COV, COV, COV, COV, CYH, CYH, CYH, CYH, CYH, CFN, CFN, CFN, CFN, CFN, BMTI, BMTI, BMTI, BMTI, BMTI, BAX, BAX, BAX, BAX, BAX, AXGN, AXGN, AXGN, AXGN, AXGN, AUXL, AUXL, AUXL, AUXL, AUXL, OSIR, OSIR, OSIR, OSIR, OSIRAmerican Academy of Orthopaedic Surgeons to host annual meeting
AAOS 2013 Annual Meeting is being held in Chicago on March 19-23.
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August 22, 2014
07:01 EDTCOVCovidien acquires Reverse Medical, terms not disclosed
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August 21, 2014
15:37 EDTBAXNektar: Baxter announces positive results from Phase 3 study of BAX 855
Nektar Therapeutics (NKTR) reports Baxter International (BAX) announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 - 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study
09:07 EDTAUXLOn The Fly: Pre-market Movers
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09:02 EDTBAXBaxter announces BAX 855 met primary endpoint in Phase 3 study
Baxter announced "positive" results from its Phase 3 pivotal clinical trial of BAX 855, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95% reduction in median ABR as compared to those in the on-demand arm. BAX 855 was also effective in treating bleeding episodes, 96% of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 – 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study.
07:32 EDTAUXLAuxilium announces positive data from Phase 2a study of CCH with cellulite
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August 20, 2014
08:47 EDTMDTMedtronic valuation attractive, says Morgan Stanley
Morgan Stanley said Medtronic's (MDT) valuation is attractive given pipeline execution, margin growth and shareholder returns, and expectations for the Covidien (COV) deal to go through. Shares are Overweight rated
07:18 EDTCOV, MDTMedtronic shares have upside with or without deal, says Deutsche Bank
Deutsche Bank sees limited downside risk and significant upside potential for shares of Medtronic (MDT), with or without the pending Covidien (COV) acquisition. Deutsche says the Q1 results show improving trends and it keeps a Buy rating on Medtronic with an $85 price target.
August 19, 2014
16:33 EDTBAXBaxter to expand Alabama facility to increase dialyzers production
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08:40 EDTMDTMedtronic sees FY15 gross margin of 74.5%-75%, with Q2 on lower end of range
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08:25 EDTMDTMedtronic: Negative factors in Spine segment in Q1 werre temporary
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08:22 EDTMDT, COVMedtronic: We will continue to pay significant US taxes following Covidien deal
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07:19 EDTMDTMedtronic backs FY15 EPS view of $4.00-$4.10, consensus $4.04
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07:17 EDTMDTMedtronic reports Q1 EPS 93c, consensus 92c
Reports Q1 revenue $4.27B, consensus $4.25B.
August 18, 2014
16:10 EDTCOVCovidien says study shows directional atherectomy safe, effective
Covidien announced that directional atherectomy is "safe and effective as a frontline therapy for the treatment of peripheral arterial disease," according to a Covidien study published online today in the Journal of American College of Cardiology, Cardiovascular Interventions. Results from the DEFINITIVE LE study using Covidien’s TurboHawk and/or SilverHawk directional atherectomy systems demonstrated 95% limb salvage in patients with critical limb ischemia and 78% overall patency in claudicant patients at 12 months.
15:26 EDTMDTNotable companies reporting before tomorrow's open
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14:49 EDTMDTMedtronic technical comments before earnings
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13:59 EDTMDTMedtronic August weekly 63.5 straddle priced for 2% move into Q1
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11:41 EDTAUXLCubist rises after report sparks takeover interest speculation
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10:41 EDTCYHCommunity Health discloses personal data compromised in cyber attack
Earlier today, Community Health (CYH) disclosed in a filing that in July Community Health Systems confirmed that its computer network was the target of an external, criminal cyber attack that the company believes occurred in April and June. The company and its forensic expert, Mandiant, a FireEye company (FEYE), believe the attacker was an “Advanced Persistent Threat” group originating from China who used highly sophisticated malware and technology to attack the company’s systems.The company has been informed by federal authorities and Mandiant that this intruder has typically sought valuable intellectual property, such as medical device and equipment development data. However, in this instance the data transferred was non-medical patient identification data related to the company’s physician practice operations and affected approximately 4.5M individuals who, in the last five years, were referred for or received services from physicians affiliated with the company. The company has confirmed that this data did not include patient credit card, medical or clinical information; the data is, however, considered protected under the Health Insurance Portability and Accountability Act because it includes patient names, addresses, birthdates, telephone numbers and social security numbers. The company does not believe this incident will have a material adverse effect on its business or financial results.
06:24 EDTMDTOptions expected to be active
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