Drugs

Teva Wants to Intervene in Amgen Sensipar Case

Teva and its Barr Laboratories and Watson Laboratories subsidiaries are asking the DC federal court for permission to intervene in Amgen’s suit against FDA over the agency’s refusal to grant the company pediatric exclusivity for its Sensipar (cinacalcet hydrochloride). The generic companies argue that Amgen’s suit, which has been put on hold by the court, “is attempting to delay FDA’s ability to grant final approval to Teva, Barr, and Watson by securing pediatric exclusivity for Sensipar.”

The filing notes that FDA rejected Amgen’s pediatric study reports because the company did not “fairly respond” to the agency study request. It argues that Amgen thus is not eligible for pediatric exclusivity patent extensions. “In this lawsuit, Amgen seeks to reverse FDA’s expert decision; if successful, the action would delay the proposed intervenors’ ability to secure final approval to market generic versions of Sensipar by adding a six-month marketing exclusivity to the end of the terms of its Orange Book patents,” Teva and its subsidiaries say. “Because the relief that Amgen seeks would interfere with the proposed intervenors’ legally protected interest to market generic versions to compete with Sensipar, this court should grant their timely motion to intervene….” The filing says that Amgen does not object to the Teva motion.

In June, the district court put the suit on hold while Amgen sought a resolution through the FDA formal dispute resolution process.

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