Drugs

Novartis Afinitor Disperz Approved for Certain Seizures

FDA has approved a Novartis NDA for Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric patients aged two years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Approval is based on data from the EXIST-3 Phase 3 study that significantly reduced the frequency of treatment-resistant seizures associated with TSC compared to placebo, according to the company. Afinitor is also currently approved for treating TSC-associated non-cancerous brain tumors (subependymal giant cell astrocytoma) and TSC-associated kidney tumors (renal angiomyolipoma).

Novartis says that Afinitor works by inhibiting the mammalian target of rapamycin (mTOR), a protein that regulates multiple cellular functions. “Treatment with an mTOR inhibitor in animal models of mTOR dysregulation in the brain resulted in prolonged survival, seizure suppression, prevention of the development of new-onset seizures, and prevention of premature death,” it says.

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