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FDA Internal Review of Sofosbuvir
tkim@idsociety.org
Posted: Wednesday, October 23, 2013 1:21 PM
Joined: 2/20/2013
Posts: 37


"Friday's FDA panel review of Gilead's hep C drug sofosbuvir is shaping up as a marketing event. In an internal staff review released this morning, regulators said that the hep C drug combined with ribavirin would offer the first all-oral treatment for two key genotypes of hepatitis C patients, offering faster cures and an improved safety profile over anything currently on the market. And it presents a promising alternative for the large number of patients who can't tolerate the harsh impact of interferon injections."

To read more, please visit: http://www.fiercebiotech.com/story/fda-review-heralds-first-class-status-gileads-hep-c-drug-sofosbuvir/2013-10-23?utm_medium=nl&utm_source=internal