Drugs

FDA Nixes Eagle Pharma Orphan Exclusivity Request

FDA has denied an Eagle Pharmaceuticals request for seven years orphan drug exclusivity for Bendeka (bendamustine HCI), a liquid, low-volume (50 mL) 10-minute infusion for treating chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle believes that the agency’s decision is incorrect, and that it was automatically entitled to orphan drug exclusivity for CLL and indolent B-cell NHL upon the drug’s 12/2015 approval.

Bendeka’s active ingredient was previously approved, and FDA currently requires sponsors of such orphan-designated drugs to make a “clinical superiority” demonstration as a condition to obtaining the seven-year exclusivity period upon approval (see earlier story). In 2014, DepoMed prevailed in federal court after challenging the agency’s application of this clinical superiority demonstration requirement to its orphan-designated drug product, Gralise. Eagle says the current rejection “closely mirrors” the decision in the DepoMed litigation, and it says it is “evaluating all options to obtain a reversal of the FDA’s Bendeka decision at this time.”

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