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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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May 29, 2015
16:00 EDTGILDOptions Update; May 29, 2015
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May 28, 2015
09:34 EDTGILDActive equity options trading on open
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08:35 EDTGILDGilead: MAA for fixed-dose Emtricitabine, Tenofovir Alafenamide validated by EMA
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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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