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March 27, 2014
08:17 EDTBMY, PFEPfizer, Bristol-Myers announce results of subanalysis of Phase 3 ARISTOTLE trial
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced the results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis compared to warfarin according to blood pressure control.1 The results showed that poor blood pressure control was associated with a substantially higher risk of stroke or systemic embolism, independent of Eliquis or warfarin treatment. However, this subanalysis found consistent results for Eliquis versus warfarin in reducing the risk of stroke, regardless of blood pressure control. These data will be presented Saturday, March 29, at the American College of Cardiology’s 63rd Annual Scientific Session in Washington, D.C. In this subanalysis, the effect of Eliquis in reducing the risk of stroke and systemic embolism versus warfarin was consistent with the main results of the ARISTOTLE trial. Further, the effect of Eliquis in reducing the risk of stroke and systemic embolism versus warfarin was also consistent with the results of the ARISTOTLE trial in previously published subanalyses of other comorbidities, including congestive heart failure, advanced age, renal impairment and prior stroke. A total of 11 Bristol-Myers Squibb/Pfizer alliance-sponsored abstracts, including this ARISTOTLE subanalysis, were accepted for presentation at the American College of Cardiology’s 63rd Annual Scientific Session.
News For PFE;BMY From The Last 14 Days
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July 28, 2015
07:18 EDTPFEPfizer raises FY15 adjusted EPS view to $2.01-$2.07, consensus $2.04
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07:17 EDTPFEPfizer reports Q2 innovative products revenue $6.63B, up 8%
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07:02 EDTPFEPfizer reports Q2 EPS adjusted 56c, consensus 52c
Reports Q2 revenue $11.9B, consensus $11.42B.
July 27, 2015
18:30 EDTPFEAllergan CEO pursuing 'transformational deals,' FT says
In a Financial Times interview following the sale of its generics unit to Teva (TEVA), Allergan's (AGN) CEO Brent Saunders stated, "We’re going to contemplate transformational deals... We couldn’t before because of our capital structure and debt, but now we can." When asked about the timing of a potential deal, Saunders remarked, "We’re not going to plod along," and when asked about a hypothetical takeover by Pfizer (PFE), the CEO commented, "I spend zero time thinking about Pfizer and I am not doing anything to make us more or less attractive to them." Reference Link
16:00 EDTPFEOptions Update; July 27, 2015
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15:03 EDTPFENotable companies reporting before tomorrow's open
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12:36 EDTPFEEarnings Watch: Pfizer shares nearly flat since last earnings report
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07:01 EDTBMYBristol-Myers, AbbVie say EMA validates for review Empliciti MAA
Bristol-Myers Squibb Company (BMY) and AbbVie (ABBV) announced the European Medicines Agency validated for review the Marketing Authorization Application for Empliciti, an investigational Signaling Lymphocyte Activation Molecule-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in adult patients who have received one or more prior therapies. The application was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use. Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health authorities, will serve as the trade name for elotuzumab. The MAA is primarily supported by data from two randomized clinical trials, each combining Empliciti with a different standard of care regimen for multiple myeloma. ELOQUENT-2, a Phase 3, randomized, open-label study, evaluated Empliciti in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone. The results of this trial were published in The New England Journal of Medicine on June 2. Additionally, a Phase 2, randomized, open-label study evaluated Empliciti with bortezomib and dexamethasone versus bortezomib and dexamethasone alone. These Phase 2 results were presented in an oral session at the 20th Congress of the European Hematology Association. Empliciti previously obtained orphan drug designation in the European Union. An orphan medicinal product must be intended for the treatment, prevention or diagnosis of a disease that is life threatening and chronically debilitating; the prevalence in the EU must not be more than five in 10,000. The medicine must be of significant benefit to those affected by the condition. If maintained, orphan drug designation allows sponsors to access a number of incentives including protocol assistance and receive market exclusivity for a ten-year period following approval.
July 24, 2015
14:08 EDTBMYBristol-Myers confirms FDA approval of hepatitis drug Daklinza
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13:49 EDTBMYFDA approves new treatment for chronic hepatitis C genotype 3
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11:02 EDTBMYBristol-Myers selects Jones Lang LaSalle for facility management
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July 23, 2015
18:21 EDTBMYOn The Fly: Top stock stories for Thursday
Stocks began the session mixed on the heels of weak earnings reports from both Caterpillar (CAT) and 3M (MMM). The Nasdaq managed to spend most of the day in positive territory but joined the other averages in negative territory by mid-afternoon. Selling picked up momentum towards late afternoon, and by day’s end each of the averages were lower by more than 0.4%, with the Dow losing nearly 0.7%. ECONOMIC EVENTS: In the U.S., initial jobless claims fell to 255,000 in the week ended July 18, below the 278,000 first-time claims that were expected. The Leading Economic Indicators advanced 0.6% in June, exceeding expectations for a 0.3% increase. In Asia, the Shanghai Composite index advanced for a sixth straight session, adding another 2.4%. In Europe, the Greek Parliament voted to accept creditor terms for a new bailout, though a decision on when to reopen Greek financial markets was deferred to next week. COMPANY NEWS: Shares of General Motors (GM) finished the session up 3.96% to $31.50 after reporting earnings per share above analyst expectations. Other notable names rising following earnings reports include SanDisk (SNDK), Under Armour (UA), Southwest (LUV)... Caterpillar, meanwhile, dropped $2.86, or 3.59%, to $76.90 after cutting its yearly guidance during this morning's earnings report, with the company noting a "relatively stagnant" global economy. Also lower following earnings were Comcast (CMCSA, CMCSK), Bristol-Myers Squibb (BMY), Dunkin Brands (DNKN), and Boston Scientific (BSX). MAJOR MOVERS: Among the notable gainers was Cigna (CI), which rose $3.29, or 2.18%, to $154.36 after the Wall Street Journal reported last night that Anthem (ANTM) is nearing a deal to acquire the company for roughly $187, representing a total transaction value of over $48B. Adding to that report, CNBC's David Faber said on Thursday morning that Anthem will announce an agreement Friday to purchase Cigna for $188 per share, at a 45% equity, 55% cash split. Also higher were shares of numerous IT security companies, with FireEye (FEYE) advancing 4.53% and Palo Alto Networks (PANW) adding 2.33% after earnings reports from security firms Fortinet (FTNT) and F5 Networks (FFIV) beat on both top and bottom lines. Fortinet and F5, meanwhile, finished Thursday's session up 10.71% and 7.75% to $46.83 and $127.68, respectively. Among the noteworthy losers following earnings was McDonald's (MCD), which edged down 0.52% to $97.10 after noting that Q2 global comparable sales fell 0.7% for the quarter, including a 2% decline in U.S. same-store sales. Also lower was Hertz (HTZ), which declined 8.53% to $16.45 following a downgrade to Underweight at Morgan Stanley, with the research firm citing increased competition from Uber and similar mobility services. INDEXES: The Dow fell 119.12, or 0.67%, to 17,731.92, the Nasdaq lost 25.36, or 0.49%, to 5,146.41, and the S&P 500 declined 12.00, or 0.57%, to 2,102.15.
07:34 EDTBMYBristol-Myers raises FY15 adjusted EPS view to $1.70-$1.80 from $1.60-$1.70
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07:31 EDTBMYBristol-Myers reports Q2 EPS 53c, consensus 36c
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06:38 EDTBMYBristol-Myers' two Opdivo applications validated by European Medicines Agency
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July 22, 2015
15:26 EDTBMYNotable companies reporting before tomorrow's open
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08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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July 21, 2015
14:03 EDTBMYBristol-Myers: Data from Phase IIa study support further evaluation of BMS955176
Bristol-Myers Squibb announced additional Phase IIa proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings, which are being presented in a late-breaking oral presentation at the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir and support further development of the second-generation HIV-1 maturation inhibitor. BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral lifecycle, resulting in the release of immature non-infectious HIV-1 particles. As part of a multi-part proof-of-concept study, a two-drug combination of BMS-955176 plus atazanavir had a maximum median change in HIV-1 RNA of -2.23 log10 c/mL from baseline through study discharge. The standard of care control of atazanavir 300 mg and ritonavir 100 mg plus tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg in a fixed dose combination had a maximum median change in HIV-1 RNA of -2.39 log10 c/mL from baseline through study discharge. In addition, a lower dose of BMS-955176 plus atazanavir and ritonavir had a similar maximum median change in HIV-1 RNA of -2.20 log10 c/mL. Length of therapy for all treatment groups was 28 days. Study endpoints included change in HIV-1 RNA from baseline to Day 28 and from baseline to the end of the study and safety. Data from Part A and Part B of the Phase IIa proof-of-concept study support the further evaluation of BMS-955176 in novel treatment regimens such as nucleos(t)ide- and booster-sparing regimens to address key unmet needs for HIV-1 treatment-experienced patients. Two Phase IIb studies have started in 2015: a traditional dose-finding study in treatment-naive patients and a second Phase IIb study to evaluate a nucleos(t)ide- and booster-sparing regimen in treatment-experienced patients.
09:02 EDTBMYBristol-Myers Squibb receives FDA breakthrough designation for HIV-1 inhibitor
Bristol-Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral, or ARV, agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
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