Devices

Mansfield Ditches FDA to Join Cancer Screening-developer Grail

FDA deputy director for personalized medicine Elizabeth Mansfield is leaving the agency next week to join cancer screening start-up Grail Inc. as its head of regulatory strategy. Mansfield had been at FDA for 10 years.

Grail is a spin-off from Illumina, which makes most of the DNA sequencing machines that scientists and doctors use to study human biology, diagnose rare genetic diseases and select cancer therapies for treating patients. It just announced plans to raise $1 billion in venture capital in its second financing round.

Grail says it will use the proceeds for continued development and validation of their blood-based test for cancer screening, which will require large-scale clinical trials including the previously announced Circulating Cell-free Genome Atlas study. “We founded Grail a year ago to enable early cancer detection via a blood-based screening test powered by Illumina sequencing technology,” says CEO Jay Flatley. “This raise, when completed, will provide GRAIL the resources to develop its first products and embark on the large-scale trials required to demonstrate the stringent performance requirements of a cancer screening test.”

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