Drugs

Bumpus Named Chief Scientific Officer at Charles River Labs

Charles River Laboratories has named former FDA principal deputy commissioner Namandjé N. Bumpus as senior vice president and chief scientific and innovation officer. In this role, Bumpus will lead the company’s scientific strategy, oversee research and development initiatives, and advance innovation to support clients in accelerating the drug development process.

Last October, Bumpus was chosen by Charles River to chair a new global scientific advisory board to guide the company’s strategy in advancing “new approach methodologies,” non-clinical tools designed to improve the predictability of safety and efficacy while reducing reliance on animal testing.

Bumpus left FDA shortly before president Trump took office in January. She was named principal deputy commissioner in 2024, succeeding Janet Woodcock after her retirement. She was named chief scientist 6/2022 after serving as E.K. Marshall and Thomas H. Maren Professor and chair of the Department of Pharmacology and Molecular Sciences at Johns Hopkins University School of Medicine. Previously, Bumpus was associate dean for basic research at the same school. “Bumpus’ research has focused on drug metabolism, pharmacogenetics, bioanalytical chemistry, and infectious disease pharmacology,” according to her bio.

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