Drugs

Appeals Court Reverses Catalyst Firdapse Loss to FDA

The 11^th Circuit Court of Appeals has overturned a Florida federal court decision granting summary judgment to FDA and Jacobus Pharmaceutical and dismissing Catalyst Pharmaceuticals’ case involving orphan drug exclusivity for its Firdapse (amifampridine) to treat Lambert-Eaton myasthenic syndrome (LEMS). Catalyst had challenged FDA’s approval of Jacobus’ Ruzurgi (amifampridine) for orphan drug status due to the agency’s earlier approval of Firdapse for orphan drug exclusivity.

A magistrate judge had recommended that the language in the Orphan Drug Act was ambiguous and that FDA’s interpretation of that language and of the labeling requirement that led to the Jacobus drug being approved was reasonable.

But the appeals court held that the lower court erred in accepting the magistrate judge’s recommendation that the statutory language was ambiguous. It remanded the case to the district court with an order that it vacate the summary judgment in favor of FDA and Jacobus and enter summary judgment in favor of Catalyst.

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