Drugs

Pew Launching Antibiotic Info-Sharing Platform

The Pew Charitable Trusts says it will launch within a year its Shared Platform for Antibiotic Research and Knowledge (SPARK), where researchers can share data, ideas, and insights to spur discovery of innovative new antibiotics. An announcement says the cloud-based resource will “integrate research data with analysis by leading experts, and provide an opportunity for real-time collaboration among scientists in industry, academia, government, and the nonprofit sector.”

In its pilot phase, Pew says, SPARK will focus on data relevant to the unique challenges of finding and designing antibiotics that can defeat drug-resistant Gram-negative bacteria. SPARK data will initially be curated from publicly available sources such as published research articles. However, it also will have the capability to host and harmonize previously unpublished data and prospective research findings from studies still in progress.

The charity says SPARK is part of its ongoing work to advance its Scientific Roadmap for Antibiotic Discovery that outlined the need to share information, expertise, and materials across the research community.

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