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News Breaks
July 25, 2014
07:25 EDTGILDGilead receives positive opinion from CHMP for Zydelig
Gilead Sciences announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorization Application for Zydelig, a first-in-class treatment for patients with chronic lymphocytic leukemia and follicular lymphoma, the most common subtype of indolent non-Hodgkin lymphoma. The CHMP opinion supports the use of Zydelig in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy and also as monotherapy for the treatment of adult patients with FL that is refractory to two prior lines of treatment. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. The CHMP positive opinion for Zydelig is based on data from two clinical trials – Study 116 and Study 101-09. Study 116, a pivotal Phase 3 trial, investigated the efficacy and safety of Zydelig in combination with rituximab in patients with previously treated CLL. The Phase 2 101-09 study assessed the efficacy and safety of Zydelig in patients with iNHL who are refractory to rituximab and alkylating agents. Results of Study 116 and Study 101-09 were published in The New England Journal of Medicine in March 2014.
News For GILD From The Last 14 Days
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May 27, 2015
16:51 EDTGILDGilead inaugurates new lab and $100M investment
Gilead Sciences' wholly-owned subsidiary Gilead Alberta ULC opened the first of two new laboratory buildings at its Edmonton campus, and announced an additional $100M investment to further expand and upgrade the site as the biopharmaceutical company broadens its pipeline of treatments in areas of unmet medical need. A second laboratory building is under construction and set for completion in the spring of 2016.
13:45 EDTGILDGilead HBV future likely from assets other than GS-4774, says Deutsche Bank
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May 26, 2015
10:46 EDTGILDAnthem sued for denying coverage for Gilead's Harvoni, WSJ says
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May 22, 2015
16:00 EDTGILDOptions Update; May 22, 2015
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May 21, 2015
10:58 EDTGILDDeutsche Bank biotech analyst holds an analyst/industry conference call
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May 20, 2015
09:07 EDTGILDGilead's patent for Hep C drug sofosbuvir challenged by NGO's in five countries
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May 19, 2015
10:09 EDTGILDGilead CFO says 'really excited' about options to grow beyond 2018
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07:56 EDTGILDGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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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.

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