Drugs

Alzheimer’s Treatment, Diagnostic Registry Launched

The Alzheimer’s Association is providing seed money to launch a new National Treatment and Diagnostic Alzheimer’s Registry. The advocacy organization says the registry will be an “FDA-approved agent agnostic approach to gathering routine clinical practice data and outcomes for sharing quickly and transparently with all stakeholders.”

The association says it is working on the registry with the American College of Radiology, the American Society of Neuroradiology, and the Brown University School of Public Health Department of Biostatistics, along with other clinical research experts.

Having such a registry is important, the association says, as a result of the FDA accelerated approval for Biogen’s Aduhelm (aducanumab) and word that sponsors of at least two additional disease-modifying drugs for Alzheimer’s are going to apply for FDA accelerated approval.

“Creation of a national provider registry for disease-modifying Alzheimer’s treatments, and for the associated diagnostic tests and biomarkers, is meant to swiftly advance the science,” says association chief science officer Maria Carrillo. “The pipeline is growing and more exciting advances are around the corner, including several more disease-modifying therapies that may be approved in the next two to five years.”

According to the association, the registry will be designed to continuously collect routine clinical practice data over time from healthcare providers caring for patients diagnosed with Alzheimer’s who are taking an FDA-approved disease-modifying treatment. It will be designed to grow with scientific and medical advancements. “As new drugs are approved and implemented in care, these will also be captured by the registry,” the association says.

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