ADVFN - Advanced Financial Network.
HOME» NASDAQ » G » GILD Stock Price » GILD Stock News

Gilead Sciences Share News

 Gilead Sciences (mm) Stock Price
GILD Stock Price
 Gilead Sciences (mm) Stock Chart
GILD Stock Chart
 Gilead Sciences (mm) Stock News
GILD Stock News
 Gilead Sciences (mm) Company Information
GILD Company Information
 Gilead Sciences (mm) Stock Trades
GILD Stock Trades

FDA: Safety Of Proposed Gilead HIV Drug "Generally Acceptable"

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration said the safety of an experimental Gilead Sciences Inc. (GILD) HIV medicine that combines four medicines into one pill was "generally acceptable." The drug, known as the Quad, combines Gilead's double-drug Truvada, the drug elvitegravir and an agent that boosts blood levels of certain HIV drugs, cobicistat. The company is seeking FDA approval for the medicine, and the product will be reviewed Friday by the agency's antiviral drugs advisory panel. The panel of non-FDA medical experts will make a recommendation to the agency about whether it thinks the Quad should be approved. The FDA released background material Wednesday in preparation for the meeting. The agency said clinical studies of the Quad showed it met study goals looking at effectiveness by reducing viral load in patients and said adverse-events were similar among patients treated with the Quad compared to those being treated with other HIV drugs. However, the FDA said it appeared that more patients in the Quad study groups stopped the drug because of kidney-related side-effects compared to patients not receiving the drug. Gilead is hoping that the one-pill, once-daily Quad regimen will provide more convenience to HIV patients, many of whom now take multiple pills for treatment. Some analysts think it could become a blockbuster seller. Gilead submitted two clinical studies involving Quad. One 700-patient study compared it with Atripla, which combines three HIV medicines in a single, once-daily pill, as an initial therapy for HIV infection. Atripla is a combination of Gilead's Truvada with Bristol-Myers Squibb Co.'s (BMY) Sustiva. The study met its goal of showing both drugs were similar at treating HIV by suppressing the so-called viral load. The study found that 88% of Quad recipients had viral suppression 48 weeks after starting treatment, versus 84% of Atripla users. Another study involving about 700 patients compared the Quad to patients taking Truvada in addition to another HIV drug, atazanavir/ritonavir and showed the Quad reduced viral load in 90% of patients after 48 weeks compared to 87% of patients being treated with the other drugs. -By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

Stock News for Gilead Sciences (GILD)
DateTimeHeadline
07/03/201502:00:00Japan’s Ministry of Health, Labour & Welfare Approves Gilead’s Har...
07/02/201516:57:00Gilead reicht bei US-amerikanischer Food & Drug Administration...
07/02/201511:01:00Gilead presenta all'ente statunitense preposto al controllo dei...
07/02/201511:00:00Gilead soumet une demande de nouveau médicament auprès de la F...
07/01/201518:52:04Statement of Changes in Beneficial Ownership (4)
07/01/201518:51:37Statement of Changes in Beneficial Ownership (4)
07/01/201518:50:41Statement of Changes in Beneficial Ownership (4)
07/01/201518:50:12Statement of Changes in Beneficial Ownership (4)
07/01/201518:49:16Statement of Changes in Beneficial Ownership (4)
07/01/201516:30:00Gilead Submits New Drug Application to U.S. Food & Drug Administration...
06/30/201519:34:02Statement of Changes in Beneficial Ownership (4)
06/29/201509:05:023 Stocks to Buy if Biotech Crashes
06/29/201508:07:03Better Dividend Stock: AbbVie or Johnson & Johnson?
06/23/201509:04:03Can a Growth Stock Also Be a Value Stock?
06/22/201516:19:04Statement of Changes in Beneficial Ownership (4)
06/21/201509:06:02Did China Just Crush Gilead Sciences' Dreams?
06/20/201515:03:03The Best Return on Equity in Biotech
06/18/201509:07:02Better Buy: Gilead Sciences Inc. or Celgene Corporation?
06/17/201519:26:25Statement of Changes in Beneficial Ownership (4)
06/17/201509:04:025 Healthcare Stocks for Dividend Lovers

Gilead Sciences and other NASDAQ stock quotes are delayed by at least 20 minutes.
All other stock price and quote data is delayed by at least 15 minutes unless otherwise stated. By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions
Contact Us | Copyright 1999-2007 ADVFN PLC. | Privacy Policy | Investment Warning | Data accreditations | Investor Relations

ADVFNADVFN ItalyADVFN GermanyADVFN FranceADVFN BrazilADVFN JapanADVFN UKADVFN US noad