Drugs

FDA Explains Novartis Data Manipulation Stance

CBER director Peter Marks tells Stat News he issued a public statement addressing Novartis’ data manipulation in the application for its Zolgensma to be sure the episode did not set back development of other gene therapies. Any case in which data are mishandled and patients are harmed could set the field of gene therapy back, Marks said in a Stat interview. “We just so happened to be lucky in this case when we looked at everything, at the end of the day, there’s no concern about this particular product. But we don’t want anyone to think that it isn’t important to do the right thing and to make sure that the information that we get is correct.”

Marks said that while the incident could make FDA staff sound like bureaucratic paper-pushers, there is more involved. “It’s making sure that the whole ecosystem understands that when people are working on these things that are highly technically complex, that they have to work truthfully and accurately. Because that’s the foundation upon which the trust that patients put in these products is built.”

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