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News Breaks | | | | January 7, 2013 | | 08:47 EDT |  | GILD | Gilead 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.” | |
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News For GILD From The Last 14 Days Check below for free stories on GILD the last two weeks. |
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| May 24, 2013 | | 07:20 EDT |  | GILD | Celgene, Gilead, and Biogen could go much higher, says Bernstein
 Subscribe for More Information | | | May 23, 2013 | | 10:27 EDT |  | GILD | Gilead has a conference call hosted by JPMorgan
Subscribe for More Information | | | May 21, 2013 | | 16:51 EDT | | GILD | Gilead's sofosbuvir gets EMA validation, now under assessment
Subscribe for More Information | | | May 20, 2013 | | 07:34 EDT | | GILD | UBS to host a conference
Subscribe for More Information | | | May 16, 2013 | | 11:50 EDT | | GILD | Celgene, Gilead lower after new data published at ASCO
Subscribe for More Information | | | May 15, 2013 | | 18:32 EDT | | GILD | Gilead announces response data from Phase 2 study of Idelalisib
Subscribe for More Information | | | May 13, 2013 | | 09:39 EDT |  | GILD | Active equity option families trading
Active equity option families trading on open according to Track Data: AAPL C TSLA LVS GILD FSLR | |
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