Drugs

FDA and COTA Ink Breast Cancer Research Pact

FDA and precision medicine technology company COTA, Inc. have a two-year research collaboration agreement (RCA) to establish a study protocol with an initial focus on breast cancer. Operating under FDA’s regulatory science research Information Exchange and Data Transformation (INFORMED) Program, the RCA is intended to provide the agency with information on the evolving treatment landscape, including insight on treatment variation within defined subpopulations of patients with breast cancer. As the project advances, the research may expand to other cancer types and explore disease characteristics, treatment patterns, and patient outcomes for the broader application of precision medicine, the company says.

“Traditional clinical trials typically have very strict eligibility criteria and don't always reflect the range of characteristics of patients in the real world,” the company says. “Real-world data provides an opportunity to improve our understanding of the experience of a broader patient population in support of developing tailored treatment decisions at the point of routine care.” The real-world evidence generated through the collaboration will be “enriched using the COTA Nodal Address (CNA) patient classification system, allowing for deeper insights and greater understanding of the variance of patient treatment and outcomes,” it 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