FDA Panel Endorses Boceprevir for Hepatitis C

SILVER SPRING, Md. -- An FDA advisory committee has voted unanimously to recommend approval of the investigational drug boceprevir (Victrelis), in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1....[more]

Experts unanimously endorse Vertex's hepatitis C drug telaprevir

An FDA advisory panel unanimously supported approval of telaprevir, Vertex Pharmaceuticals' drug candidate for hepatitis C. On Wednesday, advisers endorsed a similar drug, boceprevir, from Merck & Co. Both medicines, which...[more]

FDA Staff Sees Only Minor Issues for Telaprevir

An FDA staff assessment gave high marks to the investigational hepatitis C drug telaprevir, suggesting that the agent will sail easily through an advisory committee review on Thursday. full story

Source: medpagetoday[more]

FDA: Hepatitis C drug boceprevir works but has safety issues

FDA staff agreed with Merck & Co.'s assessment that drug candidate boceprevir is significantly more effective for hepatitis C when added to standard antiviral therapy consisting of pegylated interferon and ribavirin. However,...[more]

Costly Clotting Factor Widely Used Off Label

Off-label use of an expensive coagulant drug is skyrocketing in U.S. hospitals, but it doesn't save lives and there's some evidence it can harm patients, researchers reported. full story

Source: medpagetoday[more]

FDA panel will review hepatitis C drugs by Merck and Vertex

FDA advisers are scheduled to decide next week whether hepatitis C drug candidates boceprevir and telaprevir, from Merck & Co. and Vertex Pharmaceuticals, respectively, should be endorsed for approval. Based on efficacy data,...[more]

Study did not find XMRV in spinal fluid samples from CFS patients

A study published in the Annals of Neurology did not find signs of XMRV in the spinal fluid samples taken from 43 patients with chronic fatigue syndrome. The researchers used polymerase chain reaction methods in evaluating the...[more]