Hepatitis C : Drug Therapy http://www.idsociety.org/discussion.aspx?g=topics&f=32212256359&groupid=-1 Bristol-Myers gains FDA breakthrough track for HCV drug approval http://www.idsociety.org/discussion.aspx?g=posts&t=36507223509 Started by tkim@idsociety.org
Last Posted to on Thursday, April 25, 2013 2:00:30 PM by tkim@idsociety.org
"Bristol-Myers Squibb just gained an inside regulatory track in the frantic race to get new interferon-free hepatitis C drugs to the FDA. The big biotech reported in its quarterly statement that the agency has provided the coveted "breakthrough" status for a combination of daclatasvir with two other direct-acting antivirals, asunaprevir, an NS3 protease inhibitor and BMS-791325, an NS5B non-nucleoside polymerase inhibitor."

To read more: http://www.fiercebiotech.com/story/bristol-myers-gains-fdas-breakthrough-track-race-hep-c-drug-approval/2013-04-25#ixzz2RV0dZP00 ]]> Thu, 25 Apr 2013 18:00:30 GMT Gilead applies for FDA approval for Sofosbuvir http://www.idsociety.org/discussion.aspx?g=posts&t=36507223335 Started by ThomasKim
Last Posted to on Tuesday, April 09, 2013 1:36:57 PM by ThomasKim
"Gilead Sciences moved up again in the hepatitis C race. With a bunch of companies hurrying along all-oral programs, Gilead has taken an application to the FDA for approval of its hep C pill sofosbuvir  (GS-7977), positioning itself to become the first pharma group with a completely oral regimen on the U.S. market."

To read more: http://www.fiercebiotech.com/story/gilead-quickly-asks-fda-blockbuster-hep-c-approval/2013-04-08#ixzz2PzMX0oPz ]]> Tue, 09 Apr 2013 17:36:57 GMT J&J, Gilead combo drug therapy clears hep C in 100% of Phase IIa cohort http://www.idsociety.org/discussion.aspx?g=posts&t=36507222942 Started by ThomasKim
Last Posted to on Monday, March 04, 2013 1:00:38 PM by ThomasKim

"Medivir has posted a stellar snapshot of interim data from its Phase IIa study of a combo hepatitis C treatment that adds Gilead's hot property--GS-7977--with the Swedish biotech's simeprevir (TMC435), which is partnered with Johnson & Johnson.


The combo therapy cleared the virus in 100% of the 80 genotype 1 patients divvied into four treatment groups. All of the patients were "null-responder" hepatitis C patients with mild to moderate fibrosis. And the clear rate was the same for patients receiving 12 weeks and 24 weeks of therapy, with or without ribavirin. There were no reported incidents of serious adverse events."

For more information, please visit: http://www.fiercebiotech.com/story/jj-gilead-combo-quells-hep-c-100-phii-cohort/2013-03-04?utm_medium=nl&utm_source=internal

]]> Mon, 04 Mar 2013 18:00:38 GMT Gilead Successfully Completes Fourth Phase III Study http://www.idsociety.org/discussion.aspx?g=posts&t=32212264604 Started by tkim
Last Posted to on Tuesday, February 19, 2013 1:03:35 PM by tkim

"This morning Gilead announced that it has successfully wrapped up positive top-line data from its fourth and last Phase III study for sofosbuvir, putting the biotech on a short path to the FDA with what promises to be the first oral drug for hepatitis C."

 

To read more please visit: http://www.fiercebiotech.com/story/gilead-races-fda-after-hep-c-blockbuster-hopeful-scores-4th-win-phiii/2013-02-19?utm_medium=nl&utm_source=internal

 

]]> Tue, 19 Feb 2013 18:03:35 GMT Gilead Passes Two Phase III Test with HCV Pill http://www.idsociety.org/discussion.aspx?g=posts&t=36507222814 Started by ThomasKim
Last Posted to on Monday, February 04, 2013 4:01:20 PM by ThomasKim

"Three down, one to go. Gilead Sciences met the main goals of two Phase III studies with its blockbuster hopeful sofosbuvir in patients with hepatitis C virus. The biopharma giant aims to use the results from the late-stage studies as part of a larger data package, which will go to the FDA later this year in the company's bid to advance the first all-oral attack on the liver-damaging disease."


To read more: Gilead passes two Phase III tests with key hep C pill - FierceBiotech http://www.fiercebiotech.com/story/gilead-passes-two-phase-iii-tests-key-hep-c-pill/2013-02-04#ixzz2JxOA6nir

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