Drugs

Incyte Pulling Parsaclisib NDA

Incyte says that after discussions with FDA, it has made a business decision to withdraw its NDA for parsaclisib to treat patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. The company says its decision followed discussions with FDA about confirmatory studies needed to support an accelerated approval. Incyte says it determined the studies could not be completed within a period that would support the investment. It says the withdrawal of the NDA is not related to any changes in the drug’s safety or efficacy.

Parsaclisib is described as a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta. It is currently under evaluation as a monotherapy in Phase 2 trials to treat non-Hodgkin lymphomas and in a Phase 3 study for autoimmune hemolytic anemia, Incyte says. The company says pivotal trials of parsaclisib in combination with ruxolitinib to treat patients with myelofibrosis also are underway.

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