Drugs

Fennec Pharma ‘Complete Response’ on Pedmark

FDA has issued Fennec Pharmaceuticals a complete response letter on its NDA for Pedmark (sodium thiosulfate), for intravenous administration for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than one month of age with localized, non-metastatic, solid tumors. The agency’s letter cited manufacturing concerns from a pre-approval inspection that must be resolved prior to approving the drug. The company says it plans to request a Type A meeting to discuss the issues and other matters in the letter that addressed steps required for resubmitting the NDA.

Fennec says it is common for platinum-based therapies to cause ototoxicity in pediatric patients. The submission was based on data from two Phase 3 clinical studies of survival and reduction of ototoxicity — The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Data showed that sodium thiosulfate protects against cisplatin-induced hearing loss in children and is not associated with serious adverse events, the company 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