Drugs

AveXis Fires 2 Execs for Data Manipulation

Responding to an FDA-483 inspection report, AveXis says it has terminated two senior executives over self-reporting to FDA of data manipulation issues involving a mouse potency assay used as a product release test during the early clinical phase of its Zolgensma (onasemnogene abeparvoec-xioi). A company letter to the agency says it was alleged that the two senior executives altered or instructed others to alter a small amount of raw data used to run the in vivo relative potency assay. “Such conduct is unacceptable, and the two AveXis senior executives have been terminated,” the letter declares.

The company says it is committed to transparency with FDA and to ensuring that data it generates is attributable, legible, contemporaneous, original, and accurate. “Please note that the investigation into the data manipulation allegations was conducted with focus and diligence,” it says.

The letter details the company’s investigation process and then responds to each of the FDA-483 inspection observations.

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