Drugs

Merck Says Zepatier Tops Sovaldi Combo

Merck says that the C-EDGE comparative Phase 3 study of Zepatier (elbasvir and grazoprevir) versus a regimen of Gilead’s Sovaldi (sofosbuvir) plus peginterferon and ribavirin showed Zepatier superiority in treatment-experienced patients with chronic hepatitis C genotype 1 or 4 infection. FDA approved the drug 1/28 based in part on prior studies from the Phase 3 program.

The company describes Zepatier as a fixed-dose combination product containing elbasvir, a hepatitis C virus NS5A inhibitor, and grazoprevir, a hepatitis C virus NS3/4A protease inhibitor. It is indicated with or without ribavirin for treating chronic hepatitis C virus genotype 1 or 4 infection in adults.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome