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News Breaks
July 17, 2014
08:08 EDTPFE, BMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced that the first patient has been enrolled into a Phase IV clinical trial called EMANATE assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation undergoing cardioversion. Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with NVAF. Cardioversion is a commonly used, effective method of converting atrial fibrillation to a normal rhythm, allowing the heart to pump more effectively. Traditionally, anticoagulation is administered for a minimum of three weeks prior to cardioversion and for four weeks afterward. In some patients, early cardioversion can be performed on the same day or within days of new-onset NVAF, usually after imaging, to confirm the absence of a pre-existing thrombus in the heart, which could be dislodged during the cardioversion procedure and cause a stroke. EMANATE, a randomized, open-label clinical trial, will assess the effectiveness and safety of Eliquis compared with usual care initiated in patients with NVAF expected to undergo cardioversion after short-term anticoagulation, in a clinical practice setting. In NVAF patients presenting at least 48 hours after the onset of NVAF, early cardioversion will be performed after excluding a thrombus by imaging, on the same day or within a few days. In NVAF patients presenting within 48 hours of the onset of NVAF, cardioversion will be performed promptly without prior imaging. In all patients, Eliquis or usual care will be initiated prior to cardioversion and continued for up to 30 days post-cardioversion. The EMANATE trial is anticipated to enroll 1,500 eligible patients from the U.S., Canada, Europe and Asia. Patients will be randomized 1:1 to Eliquis or usual care, to be administered for up to 30 days following early cardioversion or 90 days post randomization if cardioversion is not performed within this timeframe. The primary efficacy endpoints are the occurrence of acute stroke, systemic embolism and all-cause death. Primary safety endpoints are major bleeding and clinically relevant non-major bleeding.
News For BMY;PFE From The Last 14 Days
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May 26, 2015
07:37 EDTBMYBristol-Myers opportunity in renal cell over $2B, says JPMorgan
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May 22, 2015
10:52 EDTBMY, PFEJPMorgan says Actavis shares cheap compared to peers
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07:33 EDTBMYBristol-Myers receives positive CHMP opinion for Nivolumab
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May 21, 2015
07:37 EDTBMY, PFEPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
09:01 EDTBMYBristol-Myers receives amended breakthrough therapy designation for daclatasvir
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07:46 EDTPFEDeutsche Bank positive on potential Pfizer, GSK merger
Deutsche Bank analyst Gregg Gilbert believes a large foreign deal for Pfizer (PFE) may make sense and says a buyout of GlaxoSmithKline (GSK) could be "materially" accretive to earnings while improving the company's tax situation over time. Gilbert assumes a $60 per share buyout price for GlaxoSmithKline in a research note this morning titled "Introducing 'PfizerKline'". The stock closed yesterday up 2c to $44.68. Gilbert reiterates a Buy rating on Pfizer with a $41 price target. Shares ended yesterday up 23c to $34.21.
07:21 EDTBMYUBS to hold a conference
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May 19, 2015
08:57 EDTBMYLeerink biotech analyst holds an analyst/industry conference call
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07:56 EDTBMYGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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07:45 EDTBMYJacobs Engineering receives contract from Bristol-Myers
Jacobs Engineering (JEC) received a contract from Bristol-Myers Squibb Company (BMY) to provide construction management services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. Jacobs is also providing architectural and engineering services for the facility, which is being built to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
06:55 EDTPFEGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 18, 2015
06:58 EDTPFEActavis CEO says chances of Pfizer offer are 'unlikely', Financial Times says
Actavis (ACT) CEO Brent Saunders said the chances of Pfizer (PFE) making an offer are "incredibly unlikely," reports the Financial Times. Saunders said he has heard the gossip that Actavis could become a takeover target for a larger group, but he spends "zero time thinking about it." Reference Link
May 15, 2015
09:31 EDTPFEAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
May 14, 2015
12:29 EDTPFEPfizer receives 'second request' from FTC regarding potential Hospira merger
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11:03 EDTBMYBristol-Myers treatment of progressive supranuclear palsy granted orphan status
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10:41 EDTBMYAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:22 EDTBMYLeerink pharma/biotech analysts hold an analyst/industry conference call
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09:09 EDTBMYBristol-Myers down 1.3% after release of ASCO abstracts
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08:39 EDTPFETargacept, Catalyst Biosciences amend definitive merger agreement
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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