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February 21, 2014
11:11 EDTBMY, PFEBristol-Myers reports positive results from Phase 3 ARISTOTLE trial
Bristol-Myers Squibb (BMY) and Pfizer (PFE) announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in relation to patient age. ARISTOTLE was designed to evaluate the efficacy and safety of Eliquis compared to warfarin for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation. This subanalysis found consistent results across age groups for reducing the risk of stroke and systemic embolism and reducing the risk of all-cause death with fewer bleeding events. Owing to the higher risk at older age, age 75 and older, the absolute benefit to patients with NVAF was greater with Eliquis in the older population. These data were published in the European Heart Journal. Eliquis was more effective than warfarin in reducing the risk of stroke and reducing mortality across age groups, and was associated with less major bleeding, less total bleeding and less intracranial hemorrhage, regardless of age. The p-value for interaction across age groups was non-significant (p>0.11 for all) for the major outcomes of stroke and systemic embolism, major bleeding, and death, meaning that the results of this subanalysis were consistent with the overall results of the ARISTOTLE trial. “Patients with atrial fibrillation are at an increased risk of major cardiovascular events such as stroke, and this risk increases substantially with age,” said study lead author Dr. Sigrun Halvorsen, Department of Cardiology, Oslo University Hospital, Norway. “Eliquis has demonstrated superiority versus warfarin for reducing the risk of stroke and all-cause mortality with fewer major bleeding events in patients with NVAF with consistency across age groups, including patients 75 and older and the very elderly over the age of 80.”
News For BMY;PFE From The Last 14 Days
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October 20, 2014
07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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October 16, 2014
10:01 EDTBMYOn The Fly: Analyst Upgrade Summary
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08:42 EDTBMYBristol-Myers upgraded at BMO Capital
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08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
October 15, 2014
15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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09:57 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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October 14, 2014
11:23 EDTBMY, PFEBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
08:05 EDTBMYBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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07:13 EDTBMYBioFlorida to hold a conference
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October 10, 2014
10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
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08:19 EDTBMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
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08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
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