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January 24, 2014
10:49 EDTBMYBristol-Myers sees 'encouraging' trends for Eliquis with hopes of expansion
Expects to have data from third line Phase II study in squamous non-small cell lung cancer in first part of 2014. It will also continue to explore combinations as well as initiating first line Phase III monotherapy study. Bristol-Myers said assets in the U.S. are in a much better position entering 2014 for both commercial and Medicare Part D plans. Total commercial costs in 2014 are expected to increase from 2013 due to the diabetes transaction. Comments taken from Q4 earnings conference call.
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April 23, 2014
07:37 EDTBMYPeregrine announces investigator-sponsored combination trial with Bristol-Myers
Peregrine Pharmaceuticals (PPHM) announced the opening of an investigator-sponsored trial, or IST, of its investigational immunotherapy bavituximab in combination with Bristol-Myers Squibb's (BMY) ipilimumab, for the treatment of advanced melanoma. Bavituximab is an upstream immune checkpoint inhibitor that targets phosphatidylserine, or PS, a highly immunosuppressive molecule exposed on cells that line tumor blood vessels and tumor cells. Preclinical data in a model of melanoma demonstrate that the combination of a bavituximab equivalent and ipilimumab yield enhanced anti-tumor activity compared to ipilimumab alone. The trial is being conducted at the University of Texas Southwestern Medical Center, Dallas, and led by Arthur E. Frankel, M.D., Associate Professor of Internal Medicine at the Simmons Comprehensive Cancer Center. Bavituximab, Peregrine's lead immuno-oncology candidate, is being evaluated in second-line non-small cell lung cancer, as part of the SUNRISE pivotal Phase III clinical trial.
06:16 EDTBMYPharmaceutical companies narrowing focus, WSJ reports
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April 22, 2014
19:03 EDTBMY Bristol-Myers and Samsung BioLogics to increase scope of existing agreement
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14:47 EDTBMYOnglyza, Kombiglyze XR get Paragraph IV patent challenges
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April 21, 2014
07:21 EDTBMYFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
April 19, 2014
11:12 EDTBMYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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April 15, 2014
08:23 EDTBMYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:19 EDTBMYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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06:32 EDTBMYPatients 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
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 10, 2014
07:04 EDTBMYBristol-Myers presents Phase III data on all-oral Daclatasvir and Asunaprevir
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