Month: April 2014

So Many HCV “Guidelines”: Can’t We Wait Till the Dust Has Settled?

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It was clear from the outset that the new roster of HCV drugs would change the playing field. Gilead’s NS5B polymerase inhibitor sofosbuvir and J&J’s NS3/4A protease inhibitor simeprevir have already revolutionized the treatment paradigm, pushing telaprevir and boceprevir, the first-generation PIs, to the sidelines. For treatment-naïve patients with GT1, Continue reading So Many HCV “Guidelines”: Can’t We Wait Till the Dust Has Settled?→

Antibiotics with QIDP Designation – – – Updated 9-30-14

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For the latest QIDP listing, please click HERE   Since FDA issued the QIDP designation in 2012, many companies have requested this important ‘label’.  Which should not come as a surprise: QIDP status confers significant benefits – and there is no downside. While an official FDA list of drugs that have Continue reading Antibiotics with QIDP Designation – – – Updated 9-30-14→

The War about Data Access

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Several articles in the April 7 issue of BMJ were devoted to the epic battle fought by BMJ and Cochrane to gain unfettered access to the Tamiflu® and Relenza® data. Not just some data, but all the data. Considering that only 2 out of 10 Tamiflu studies were published in Continue reading The War about Data Access→