CMV Hyperimmune Globulin Data Inconclusive but New Drug Shows Promise

Treating CMV was never easy making prophylaxis the preferred approach for HSCT patients. Since the late 80ies, trials using hyperimmune globulin have come up with mixed results. While treatment was usually safe, efficacy was a lot much harder to prove.  More specific monoclonal ab preparations directed against immunodominant surface glycoproteins did not Continue reading CMV Hyperimmune Globulin Data Inconclusive but New Drug Shows Promise

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

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

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