Drugs

Dem Senators Want AveXis Punished Over Data Manipulation

A group of U.S. Senate Democrats is urging FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting “manipulated” data (see story) with recently approved Zlogensma, a gene therapy product intended to treat children less than two years old with spinal muscular atrophy. The agency says it was informed 6/28 about the data manipulation affecting the reliability of animal tests submitted in the BLA reviewed by FDA.

FDA has already said that Zlogensma will remain on the market for now. It said that the totality of the evidence demonstrating the product’s effectiveness and its safety profile continues to substantiate an overall favorable benefit-risk profile. However, the agency also said it will act against the company, if appropriate, and could impose civil or criminal penalties.

In an 8/9 letter to Sharpless, the lawmakers express anger over the data manipulation, particularly considering the expedited approval programs FDA granted the firm and the product’s $2.1 million treatment cost. “It is an outrage that after knowingly misleading the FDA in a rush to make a profit, this pharmaceutical company refused, in its 8/6/2019 press release, to acknowledge any culpability or remorse,” they wrote in the letter. “We urge you to use your full authorities to hold AveXis accountable for its malfeasance, including through all appropriate criminal, civil, and regulatory actions against the company.”

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