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News Breaks
December 26, 2012
07:34 EDTBMY, PFEPfizer, Bristol-Myers announce Japanese approval of Eliquis
Bristol-Myers Squibb (BMY) and Pfizer (PFE) announced that the Japanese Ministry of Health, Labor and Welfare has approved ELIQUIS for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). ELIQUIS is a novel anticoagulant that has demonstrated risk reductions versus warfarin in three important outcomes of stroke, major bleeding and all-cause death. ELIQUIS is an oral direct Factor Xa inhibitor, part of a novel therapeutic class. This is the third approval for ELIQUIS for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, following approvals in the European Union and Canada. The companies continue to progress the ELIQUIS application for stroke prevention in atrial fibrillation in other markets. On September 26, The U.S. Food and Drug Administration acknowledged receipt of the ELIQUIS New Drug Application resubmission to reduce the risk of stroke and systemic embolism in adult patients with NVAF. The FDA has deemed the resubmission a complete response to its June 22, 2012 Complete Response Letter that requested additional information on data management and verification from the ARISTOTLE trial. The FDA Prescription Drug User Fee Act date is March 17, 2013.
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April 15, 2014
08:04 EDTPFEWuXi PharmaTech names Steve Yang as COO and Executive VP
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06:32 EDTPFE, BMYPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
09:05 EDTPFEGlycoMimetics presents GMI-1070 data
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08:15 EDTBMYBristol-Myers submits NDA for Reyataz-cobicistat combo for HIV-1
Bristol-Myers Squibb (BMY) announced the submission of a new drug application, or NDA, on April 4 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet. Cobicistat is being developed by Gilead Sciences (GILD). Under the terms of a previously announced agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
April 11, 2014
07:19 EDTPFEAcura Pharma to host conference call
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April 10, 2014
07:04 EDTBMYBristol-Myers presents Phase III data on all-oral Daclatasvir and Asunaprevir
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06:17 EDTPFEAcura Pharma announces return of product rights from Pfizer
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April 9, 2014
11:43 EDTBMYGilead defended by analysts after recent pullback
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07:23 EDTBMYEuropean Association for the Study of the Liver to hold annual meeting
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April 8, 2014
11:03 EDTBMY, PFEPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.
April 7, 2014
17:28 EDTPFEPfizer sell-off unwarranted, Barron's says
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16:28 EDTPFEOn The Fly: Closing Wrap
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12:15 EDTPFEOn The Fly: Midday Wrap
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10:40 EDTPFEPfizer trades near lows of the day, levels to watch
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09:10 EDTPFEOn The Fly: Pre-market Movers
HIGHER: Questcor (QCOR), up 27% after agreeing to be bought by Mallinckrodt (MNK) for cash, stock valued at $86.10 per Questcor share... Agios Pharmaceuticals (AGIO), up 25% after program shows "promising clinical activity" for advanced blood cancers, shares upgraded at JPMorgan... Vocus (VOCS), up 47% after agreeing to be acquired by GTCR for $446.5M, or $18.00 per share... Pandora (P), up 1.3% following upgrade at Wedbush. LOWER: MannKind (MNKD), down 13% after announcing FDA extension of PDUFA date for Afrezza... American Eagle (AEO), down 2.2% following downgrade at Cowen... Pfizer (PFE), down 2.8% after announcing data for palbociclib in metastatic breast cancer... Mattel (MAT), down 3% following downgrade at BMO Capital... WWE (WWE), down 1.2% after cautious mention in Barron's, company announcing WrestleMania 30 grossed $10.9M.
09:09 EDTPFEConfusion on Pfizer Palbo could create buying opportunity, says BMO Capital
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09:00 EDTPFEPfizer falls 2.8%
Pfizer is down 2.8%, or 90c, to $31.25
08:06 EDTBMYBristol-Myers submits NDAs for Daclatasvir and Asunaprevir to FDA
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07:27 EDTPFEAmerican Association of Cancer Research to hold annual meeting
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April 6, 2014
13:46 EDTPFEPfizer's palbociclib significantly prolonged PFS in metastatic breast cancer
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