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News Breaks
January 7, 2013
08:47 EDTGILDGilead updates on Hepatitis C development programs
Gilead Sciences announced several updates regarding its late-stage pipeline candidates for the treatment of chronic hepatitis C virus infection. The company released new results from an arm of the ongoing Phase 2 ELECTRON study examining the nucleotide sofosbuvir and the NS5A inhibitor GS-5885, and provided a progress report on a range of Phase 2 and 3 clinical trials evaluating a once-daily fixed-dose combination tablet of these medicines. Gilead announced full data from one cohort of the ongoing Phase 2 ELECTRON study examining a 12-week course of all-oral therapy with sofosbuvir, GS-5885 and ribavirin among genotype 1 HCV patients who had previously failed to respond to an interferon-containing regimen, or “null responders.” Preliminary data, presented in November at the annual meeting of the American Association for the Study of Liver Diseases, demonstrated that three of nine patients remained HCV RNA undetectable four weeks after completing therapy. Today’s announcement confirms that all nine patients in this cohort achieved SVR4. These patients will continue to be observed to determine sustained virologic response rates at weeks 12 and 24 of follow-up. Results from eight other arms of the ELECTRON study, evaluating sofosbuvir alone and with RBV and/or pegylated IFN, were published earlier this month in the New England Journal of Medicine, the company said. The company also said these updates will be highlighted today as part of Gilead’s corporate presentation at the 31st Annual J.P. Morgan Healthcare Conference taking place in San Francisco. “Since the acquisition of Pharmasset only a year ago, we have fully enrolled four Phase 3 studies of sofosbuvir and during the first quarter of this year we will have initiated two Phase 3 studies of the sofosbuvir and GS-5885 fixed-dose combination,” said Norbert Bischofberger, PhD, Chief Scientific Officer, Gilead Sciences. “We are on track to submit the initial regulatory filing for sofosbuvir by mid-2013 and to file for approval of the fixed-dose combination of sofosbuvir and GS-5885 in 2014.”
News For GILD From The Last 14 Days
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March 25, 2015
09:35 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL TWTR TSLA KRFT FB BIDU GPRO V GILD NFLX
March 24, 2015
08:00 EDTGILDGilead shares should be bought on weakness, says Bernstein
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March 23, 2015
16:01 EDTGILDOptions Update; March 23, 2015
iPath S&P 500 VIX Short-Term Futures down 48c to 25.24 Option volume leaders: AAPL TSLA TWTR GILD CELG FB TSLA AMZN TEVA PBR according to Track Data.
11:45 EDTGILDGilead defended after slide following death of Hep C patient on heart drug
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11:32 EDTGILDStocks with call strike movement; GILD CELG
Gilead (GILD) August 115 call option implied volatility increased 5% to 27, Celgene (CELG) July 140 call option implied volatility increased 3% to 28 according to IVolatility.
09:37 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AUY SLB PFE MCP CELG VRTX SHPG GILD LOGI TSLA TASR NFLX SCTY WFM
08:44 EDTGILDGilead volatility low into FDA hepatitis C drug warning
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08:23 EDTGILDGilead weakness a buying opportunity, says RW Baird
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07:40 EDTGILDGilead weakness on FDA warning would be buying opportunity, says Wells Fargo
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06:08 EDTGILDGilead implied volatility of 23 at lower end of index mean range
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March 22, 2015
15:05 EDTGILDGilead warns after hepatitis C patient taking heart drug dies, Bloomberg says
Gilead said in an e-mailed drug warning to health-care providers on Friday that nine patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and one died of cardiac arrest, says Bloomberg. Reference Link
March 20, 2015
16:00 EDTGILDOptions Update; March 20, 2015
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15:02 EDTGILDAcelRx names Howard Rosen as interim CEO
AcelRx Pharmaceuticals (ACRX) announced the appointment of Howard Rosen as interim CEO of AcelRx, effective April 1. Rosen is a technically trained executive with over 25 years of success growing start-up and mid-size biopharmaceutical companies. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development, and research and development at Gilead Sciences (GILD) and ALZA Corporation. Rosen has served on the Board of Directors of AcelRx since 2008 and currently serves on the Board of Directors of Alcobra and several private biopharmaceutical companies.
March 19, 2015
16:01 EDTGILDOptions Update; March 19, 2015
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09:08 EDTGILDNew Gilead HIV drug likely to be approved in mid-2015, says Argus
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March 17, 2015
06:31 EDTGILDStudies find Gilead's hepatitis C drugs cost effective, Reuters says
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March 16, 2015
16:00 EDTGILDOptions Update; March 16, 2015
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March 12, 2015
12:49 EDTGILDWHO recommends tenofovir or entecavir for hepatitis B treatment
The World Health Organization issued its first-ever guidance for the treatment of chronic hepatitis B. Its recommended medicines consist of Gilead's (GILD) tenofovir or Bristol-Myers' (BMY) entecavir. Teva (TEVA) has FDA approval for generic entecavir.
12:22 EDTGILDHetero receives approval for generic Sofosbuvir in India
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12:15 EDTGILDIndia's Hetero says got approval for generic version of Sovaldi, Reuters says
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