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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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April 24, 2015
09:37 EDTGILDActive equity options trading on open
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08:33 EDTGILDGilead May weekly volatility elevated into Q1 and outlook
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April 23, 2015
16:01 EDTGILDOptions Update; April 23, 2015
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07:59 EDTGILDMylan launches generic sofosbuvir tablets in India
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05:19 EDTGILDGilead Harvoni, Sovaldi demonstrate efficacy, safety
Gilead Sciences announced results from several Phase 2 clinical studies evaluating investigational uses of Harvoni and other Sovaldi-based regimens for the treatment of chronic hepatitis C virus, or HCV, infection in patients with advanced liver disease, including patients with decompensated cirrhosis, patients with fibrosing cholestatic hepatitis C and patients with portal hypertension. In SOLAR-2, 328 genotype 1 or 4 HCV patients with decompensated liver disease before liver transplantation or recurrent HCV infection following liver transplantation were randomized to receive either 12 or 24 weeks of Harvoni plus ribavirin. Ten patients were excluded from the analysis because of transplantation or because they were pre-transplantation, but not decompensated; an additional 27 of these patients have not yet reached post-treatment week 12. The most common adverse events were fatigue, anemia, nausea and headache. Overall, six patients discontinued treatment due to adverse events, five of whom had decompensated cirrhosis.
05:16 EDTGILDGilead data supports ongoing trials evaluating shortened course of therapy
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April 22, 2015
07:07 EDTGILDEuropean Association for the Study of the Liver to hold annual meeting
50th Annual Meeting of EASL will be held in Vienna, Austria on April 22-26.
April 21, 2015
16:00 EDTGILDOptions Update; April 21, 2015
iPath S&P 500 VIX Short-Term Futures down 1c to 21.53 Option volume leaders: AAPL TSLA TWTR GILD FB PBR AMZN C KMI KO VZ MCD according to Track Data.
13:34 EDTGILDGilead paying premium to buy Vertex not warranted right now, says Maxim
After Bernstein suggested in a note to investors earlier that Gilead (GILD) should buy Vertex (VRTX), Maxim responded in its own note that it does not believe paying a premium to buy Vertex makes sense before the company has data showing efficacy for Kalydeco in heterozygotes. Maxim keeps a Hold rating and $121 price target on Vertex shares.
12:33 EDTGILDOn The Fly: Top stock stories at midday
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12:21 EDTGILDVertex rises after Bernstein suggests Gilead should pursue takeover
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10:00 EDTGILDGilead spikes higher, levels to watch
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09:37 EDTGILDActive equity options trading on open
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08:14 EDTGILDGilead should buy Vertex, says Bernstein
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06:58 EDTGILDGilead May weekly volatility elevated into Q1 and outlook
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April 20, 2015
09:36 EDTGILDActive equity options trading on open
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07:20 EDTGILDAmerican Association for Cancer Research to hold annual meeting
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April 15, 2015
16:01 EDTGILDOptions Update; April 15, 2015
iPath S&P 500 VIX Short-Term Futures down 49c to 21.90. Option volume leaders: AAPL NFLX C PBR KMI RIG MCP TWTR GILD BAC according to Track Data.
April 13, 2015
16:01 EDTGILDOptions Update; April 13, 2015
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09:34 EDTGILDActive equity options trading on open
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