Drugs

Researcher Restricted After Trial Misconduct

University of Pittsburgh researcher Kenneth Walker has entered into a voluntary settlement agreement with HHS’ Office of Research Integrity (ORI) due to “research misconduct” associated with work supported by the National Institute of Diabetes and Digestive and Kidney Diseases. ORI found that Walker engaged in research misconduct by falsifying and fabricating data that were included in two publications, one submitted manuscript, and two grant applications.

“Specifically, ORI found that respondent falsified and/or fabricated quantitative real-time polymerase chain reaction (qPCR) data to demonstrate a statistically significant or ‘trend’ of statistical difference in the expression of renal or bladder urothelium and muscle developmental markers between control and experimental (mutant) mice, when there was none,” a notice says. Walker has voluntarily agreed to have his research supervised for a period of three years, among other restrictions. He also agreed to retract or correct data in the publications.

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