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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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April 21, 2015
08:18 EDTPFEPain Therapeutics resumes responsibility for Remoxy
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08:06 EDTPFEPfizer says Phase 3 inotuzumab ozogamicin study met first primary endpoint
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06:44 EDTBMYBristol-Myers upgraded on early Opdivo success at Morgan Stanley
As previously reported, Morgan Stanley upgraded Bristol-Myers to Overweight from Equal Weight. The firm raised estimates above consensus and increased its price target on the stock to $80 from $60 following confirmation of Opdivo's survival benefits in lung cancer. Morgan Stanley expects Opdivo to be one of the top three pharma-bio launches over the next several years and notes Bristol is ahead of the competition in immuno-oncology combination drug development.
06:15 EDTBMYBristol-Myers upgraded to Overweight from Equal Weight at Morgan Stanley
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April 20, 2015
08:12 EDTBMYVanda names Tom Gibbs as SVP and Chief Commercial OfficerBristol-Myers
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08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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07:20 EDTBMYAmerican Association for Cancer Research to hold annual meeting
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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April 17, 2015
09:41 EDTBMYBristol-Myers up after Phase III Opdivo study met endpoint, trial stopped early
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09:36 EDTBMYActive equity options trading on open
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09:08 EDTBMYBristol-Myers data should be positive, says SunTrust
SunTrust expects the AACR data for Bristol-Myers' CheckMate-069 Opdivo + Yervoy combo, a treatment for melanoma, to show a positive overall response rate and progressive free survival that exceeds its prior -0004 results. The firm notes that the data is due to be presented on April 20. It raised its 2020 Opdivo revenue estimate to $7.1B versus the Street's $6.9B and raised its price target o n he stock to $74 from $70 while keeping a Buy rating on the shares.
08:58 EDTBMYBristol-Myers jumps 4% after Opdivo study stopped early after meeting endpoint
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08:56 EDTBMYBristol-Myers says Phase III Opdivo study met endpoint, trial stopped early
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April 16, 2015
12:16 EDTBMYEli Lilly and Bristol-Myers restructure Erbitux collaboration in N. America
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08:59 EDTBMYGene therapy companies could benefit from increased attention, says Roth Capital
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April 15, 2015
09:08 EDTBMYOn The Fly: Pre-market Movers
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08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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07:41 EDTBMYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:03 EDTBMYLexicon and Bristol-Myers select development candidate for neuropathic pain
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April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
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