Drugs

FDA Loses Eagle Orphan Drug Appeal

In a 2-1 ruling, the Court of Appeals for the DC Circuit has said that Eagle Pharmaceuticals deserves a seven-year orphan drug exclusivity for its Bendeka (bendamustine HCl). FDA approved Bendeka for marketing in 2015 but denied exclusivity because it said the company failed to prove that it was clinically superior to a previously designated and approved version of the same drug.

The company claimed the Orphan Drug Act requires FDA to grant marketing exclusivity upon designating the drug as an orphan drug and approving it for marketing. A federal district court upheld the company’s position and granted it summary judgment. FDA then appealed to the Court of Appeals.

The appeals court affirmed the lower court decision because the law’s text “unambiguously entitles a manufacturer to marketing exclusivity upon designation and approval.”

In a dissent, senior circuit judge Stephen Williams said the “majority’s interpretation of the statute runs counter to the best reading of the congressional language and fundamentally upsets the basic economic bargain that Congress so carefully struck.”

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