Drugs

Amgen Sues FDA for Sensipar Pediatric Exclusivity

Amgen is suing FDA for not accepting its study reports and denying six months of pediatric exclusivity for its Sensipar (cinacalcet), a management treatment for patients suffering from hyperparathyroidism. An online Life Sciences Intellectual Property Review report says Amgen claims in its filing that FDA is required to accept a firm’s study reports and grant exclusivity as long as the studies “fairly respond” to the agency’s request.

“The studies need not demonstrate that the drugs are (or are not) actually safe and effective in children to warrant pediatric exclusivity, not must they be adequate to support a pediatric indication or the drug product’s labeling, nor must the studies even ‘fully respond’ to the written request,” the company says.

Amgen says that because its studies “fairly responded” to the FDA written request, the agency’s refusal to accept the study reports and its denial of pediatric exclusivity violate the Best Pharmaceuticals for Children Act. It asked the DC federal court to vacate the FDA decision to deny pediatric exclusivity and require FDA to accept the company study reports.

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