Drugs

Celltrion Submits BLA for Novel Infliximab Formula

Celltrion USA says it has submitted to FDA a BLA for its CT-P13, a novel subcutaneous formulation of infliximab to be used as maintenance therapy in patients with moderately to severely active ulcerative colitis and Crohn’s disease. A company statement says CT-P13 is the only infliximab to have both intravenous and subcutaneous formulations.

The company says the submission was based on data from a Phase 3 pivotal trial that evaluated the formulation’s safety and efficacy for its intended use. “Based on the results of the LIBERTY-UC and LIBERTY-CD studies,” it says, “CT-P13 subcutaneous demonstrated superiority over placebo in maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with ulcerative colitis and Crohn’s disease respectively, over a one-year treatment period.”

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

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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