Drugs

Nippon Shinyaku Completes Rolling NDA for Duchenne Drug

Nippon Shinyaku says it has completed submission of a rolling NDA for its viltolarsen that is under development to treat Duchenne muscular dystrophy amenable to exon 53 skipping. The company says the drug is expected to generate functional dystrophin proteins and be effective for Duchenne muscular dystrophy amenable to dystrophin exon 53 skipping.

FDA granted the drug rare pediatric disease, orphan drug, and fast track designations.

If approved, the drug could compete with Sarepta’s golodirsen injection that received an August FDA complete response letter that Sarepta said generally raised two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of the drug and observed following administration of other antisense oligonucleotides.

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