Drugs

Santhera Pharma Delays NDA Over Inspection Readiness

Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy (DMD) has been postponed by four to six months after a third-party contract manufacturing organization (CMO) communicated a delay in reaching FDA-inspection readiness. The completed rolling NDA is now expected sometime in the fourth quarter.

The company says it began submitting the rolling NDA modules in March and it just submitted the clinical module recently. “Formal confirmation of inspection readiness by the CMO is a prerequisite for the FDA to consider a filing complete and to accept an NDA for review,” it says. “Therefore, Santhera will discuss with the agency the status and updated timelines for completing the NDA filing by Q4-2022.”

Vamorolone works by binding to the same receptor as corticosteroids but “modifies its downstream activity and as such is considered a dissociative anti-inflammatory drug,” the company says. “This mechanism has the potential to ‘dissociate’ efficacy from typical steroid safety concerns and therefore vamorolone could emerge as a promising alternative to existing corticosteroids, the current standard of care in children and adolescents with DMD.”

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