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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 companyís 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 CHMPís 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 Ė 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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February 27, 2015
07:37 EDTGILDGilead removed from the short-term buy list at Deutsche Bank
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February 26, 2015
19:09 EDTGILDGilead announces Phase 3 results for once-daily single tablet HIV regimen
Gilead Sciences announced detailed 48-week results from two Phase 3 studies, Studies 104 and 111, evaluating its investigational once-daily single tablet regimen containing tenofovir alafenamide, or TAF, for the treatment of HIV-1 infection in treatment-naÔve adults. A regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg was found to be statistically non-inferior to Gileadís Stribild, containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. A second analysis found that patients receiving the TAF regimen also had significantly better renal and bone laboratory parameters than those treated with Stribild. The data were presented in two late-breaker presentations at the 22nd Conference on Retroviruses and Opportunistic Infections in Seattle.
15:25 EDTGILDGilead announces 96% SVR12 rate in Phase 3 study of Harvoni
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February 25, 2015
15:30 EDTGILDGilead announces preclincal data on investigational TLR7 agonist
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February 24, 2015
09:35 EDTGILDActive equity options trading on open
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February 23, 2015
16:00 EDTGILDOptions Update; February 23, 2015
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09:39 EDTGILDActive equity options trading on open
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07:16 EDTGILDMylan signs exclusive agreement with Gilead to distribute Solvaldi, Harvoni
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February 19, 2015
09:35 EDTGILDOption volume leaders
Option volume leaders: AAPL TSLA TWTR MCD WMT PBR SPWR WFM GILD FB SCTY according to Track Data.
February 18, 2015
09:37 EDTGILDOption volume leaders on open
Option volume leaders: AAPL TSLA TWTR CELG APO NFLX AXP APA LNKD C GILD according to Track Data.
February 17, 2015
17:13 EDTGILDPoint72 gives quarterly update on stakes
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16:00 EDTGILDOptions Update; February 17, 2015
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13:18 EDTGILDOmega Advisors gives quarterly update on stakes
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09:40 EDTGILDActive equity options trading on open
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