Drugs

Court Rejects Amgen Sensipar Exclusivity

The DC federal court says FDA has given an adequate rationale for granting pediatric exclusivity to Johnson & Johnson’s Ortho Tri-Cyclen (ethinyl estradiol and norgestimate) but denying it for Amgen’s Sensipar (cinacalcet hydrochloride). Amgen had sued FDA over the agency’s decision not to grant Sensipar pediatric exclusivity.

The court initially granted FDA summary judgment on all but Amgen’s claim that the denial of Sensipar exclusivity was inconsistent with the agency’s decision on Ortho Tri-Cyclen and thus arbitrary and capricious. It said FDA had failed to offer a reasonable explanation for why it reached a disparate outcome and remanded the case so the agency could explain.

“On remand,” the current decision says, “FDA reaffirmed its Sensipar decision and explained why, in its view, this result was consistent with its decision on Ortho Tri-Cyclen.”

The court granted FDA’s renewed motion for summary judgment based on its analysis that FDA had now offered a reasoned explanation for its different decisions. Basically, it said, FDA concluded that the Ortho Tri-Cyclen studies met the enrollment criteria in the written request at the time of the exclusivity decision, while the Sensipar studies did not. The court said Amgen’s disagreement with the FDA conclusions was not persuasive.

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