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News Breaks
April 14, 2014
08:15 EDTBMY, GILDBristol-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.
News For BMY;GILD From The Last 14 Days
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May 20, 2015
09:01 EDTBMYBristol-Myers receives amended breakthrough therapy designation for daclatasvir
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07:21 EDTBMYUBS to hold a conference
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May 19, 2015
10:09 EDTGILDGilead CFO says 'really excited' about options to grow beyond 2018
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08:57 EDTBMYLeerink biotech analyst holds an analyst/industry conference call
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07:56 EDTBMY, GILDGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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07:45 EDTBMYJacobs Engineering receives contract from Bristol-Myers
Jacobs Engineering (JEC) received a contract from Bristol-Myers Squibb Company (BMY) to provide construction management services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. Jacobs is also providing architectural and engineering services for the facility, which is being built to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
07:28 EDTGILDUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
May 18, 2015
19:43 EDTGILDAnthem Blue Cross sued for limiting Harvoni usage, LA Times says
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16:16 EDTGILDGilead confirms plans to present tomorrow at UBS conference, Feuerstein reports
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14:42 EDTGILDAchillion rises as conference cancellation adds fuel to M&A speculation
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09:36 EDTGILDActive equity options trading on open
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May 15, 2015
16:01 EDTGILDOptions Update; May 15, 2015
iPath S&P 500 VIX Short-Term Futures down 20c to 20.06 Option volume leaders: AAPL BAC FB NFLX TWTR BABA CSCO TSLA MU GILD T MSFT AMZN MCD
11:08 EDTGILDOmega Advisors gives quarterly update on stakes
NEW STAKES: Targa Resources (TRGP), Targa Resources Partners (NGLS), Humana (HUM), Dow Chemical (DOW), and Twenty-First Century Fox (FOXA). INCREASED STAKES: Kinder Morgan (KMI), Chimera Investment Corporation (CIM), AerCap Holdings (AER), Shire (SHPG), and KKR & Co. (KKR). DECREASED STAKES: eBay (EBAY), Altisource Portfolio Solutions (ASPS), Caesars Entertainment (CZR), Navient (NAVI), and TerraForm Power (TERP). LIQUIDATED STAKES: HCA Holdings (HCA), Gilead (GILD), Cabot Oil & Gas (COG), and Apple (AAPL).
09:31 EDTGILDAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
May 14, 2015
11:03 EDTBMYBristol-Myers treatment of progressive supranuclear palsy granted orphan status
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10:41 EDTBMYAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:22 EDTBMYLeerink pharma/biotech analysts hold an analyst/industry conference call
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09:09 EDTBMYBristol-Myers down 1.3% after release of ASCO abstracts
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May 13, 2015
13:12 EDTGILD, BMYSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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07:31 EDTGILDHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
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