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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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October 13, 2014
09:56 EDTGILDBernstein biotech analyst to hold an analyst/industry conference call
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08:36 EDTGILDGilead HARVONI launch should be strong, says BMO Capital
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08:05 EDTBMYBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
07:56 EDTGILDGilead Harvoni pricing 'very reasonable,' says RBC Capital
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07:39 EDTGILDPharmaceutical Care Management Association to hold annual meeting
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07:13 EDTBMYBioFlorida to hold a conference
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October 10, 2014
14:08 EDTGILDGilead 12-week regimen of Harvoni to cost $94.5K
Gilead said its newly-approved treatment of hepatitis C genotype 1 infection, Harvoni, will be priced at $94,500 for a full 12 week regiment, according to multiple media outlets, which cite a company spokesperson.
13:55 EDTGILDGilead confirms FDA approval of Harvoni
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13:42 EDTGILDGilead hepatitis C treatment Harvoni approved by FDA
The FDA announced the approval of Harvoni to treat chronic hepatitis C virus genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection, the agency stated. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection, it added. Harvoni is marketed by Gilead.
13:40 EDTGILDFDA approves Gilead hepatitus C treatment Harvoni
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10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
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08:19 EDTBMY, GILDMedivir announces Janssen initiates enrolment in phase II IMPACT study
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07:21 EDTGILDFDA PDUFA Date for Gilead Sciences Sofosbuvir is October 10, 2014
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October 9, 2014
11:43 EDTGILDStocks with call strike movement; GILD EWZ
Gilead (GILD) February 120 call option implied volatility increased 3% to 38, MSCI Brazil Index (EWZ) February 58 call option implied volatility increased 3% to 38 according to IVolatility.
08:28 EDTGILDGilead to be challenged by AbbVie in HCV near-term, says Bernstein
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October 8, 2014
16:26 EDTGILDOn The Fly: Closing Wrap
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16:01 EDTGILDOptions Update; October 8, 2014
iPath S&P 500 VIX Short-Term Futures down 2.73 to 29.51. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX PBR AA CLF GILD according to Track Data.
15:49 EDTGILDAchillion, Gilead rise after late breaking abstract for AASLD posted
Shares of Achillion (ACHN) are higher after the company announced this morning that four abstracts have been accepted for presentation at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases. Among those four is a late breaker poster presentation providing updated results, including SVR12, from an ongoing Phase 2 proxy study evaluating Achillion's second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus infection. Sofosbuvir is sold under the brand name Sovaldi by Gilead Sciences (GILD). In a note to investors, FBR Capital noted that the "surprise" late-breaking poster for the meeting showed a 100% cure rate for the combination therapy. In late afternoon trading, Achillion shares are up 10% to $10.74 while Gilead is up 4.3% to $108.78.
08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:18 EDTGILD, BMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
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