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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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December 1, 2015
11:37 EDTGILDGilead 'respectfully disagrees' with senators' conclusions, Meg Tirrell reports
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11:36 EDTGILDGilead sought to maximize Hepatitis C revenue, Senate probe finds
Senate Finance Committee Ranking Member Ron Wyden and senior committee member Chuck Grassley released the results of an 18-month investigation into the pricing and marketing of Gilead Sciences' Hepatitis C drug Sovaldi and its successor, Harvoni. "Drawing from 20,000 pages of internal company documents, dozens of interviews with health care experts, and a trove of data from Medicaid programs in 50 states and the District of Columbia, the investigation found that the company pursued a marketing strategy and final wholesale price of Sovaldi - $1,000 per pill, or $84,000 for a single course of treatment - that it believed would maximize revenue," the senators wrote. They added, "Building on that price, Harvoni was later introduced at $94,500. Fostering broad, affordable access was not a key consideration in the process of setting the wholesale prices." In the 18 months following Sovaldi's approval, Medicare spent nearly $8.2B before rebates on Sovaldi and Harvoni, they pointed out.
09:34 EDTBMYBarclays biopharmaceuticals analysts hold analyst/industry conference call
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07:54 EDTBMYLeerink to hold a bus tour
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05:48 EDTBMYBristol-Myers assumed with an Equal Weight at Barclays
Barclays analyst Geoff Meacham kept an Equal Weight rating on Bristol-Myers after assuming coverage of the name. He raised his price target for shares to $70 from $55.
November 30, 2015
15:15 EDTBMYBristol-Myers, AbbVie confirm FDA approval of Empliciti for multiple myeloma
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11:07 EDTGILDStocks with call strike movement; GILD FB
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10:26 EDTBMYFDA approves Empliciti to treat multiple myeloma
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November 27, 2015
09:36 EDTGILDActive equity options trading on open
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November 24, 2015
09:37 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL FB BAC DIS NFLX X YNDX GILD PANW SUNW
07:01 EDTBMYBristol-Myers announces EC approved reconciliation of indications for nivolumab
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06:58 EDTBMYBristol-Myers announces FDA approval of Opdivo injection
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November 23, 2015
19:29 EDTBMYBristol-Myers receives FDA approval for Opdivo
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15:00 EDTBMYFDA approves Bristol-Myers drug to treat form of kidney cancer
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09:39 EDTGILDActive equity options trading on open
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06:41 EDTGILDGilead granted marketing authorization in EU for Genvoya
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November 18, 2015
12:01 EDTBMYBristol-Myers Squibb says Opdivo data shows 'superior' overall survival
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09:34 EDTGILDActive equity options trading on open
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08:11 EDTBMYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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November 17, 2015
10:47 EDTGILD, BMYBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.

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