Drugs

NCI Launches Cancer Collaboration Project

The National Cancer Institute (NCI) says it is working with three organizations in England and the Netherlands to develop the Human Cancer Models Initiative that will bring together expertise from around the world to make about 1,000 cancer cell models. “Using new techniques to grow cells, scientists can make models that will better resemble the tissue architecture and complexity of human tumors than the cell lines used today,” NCI says in a statement. Genetic sequencing data from the tumors and derived models will be available to researchers, along with clinical data about the patients and their tumors, NCI says. All information related to the models will be shared in a way that protects patient privacy.

The statement says that scientists will make the models using tissue from patients with different types of cancer, potentially including rare and children’s cancers, which are often underrepresented or not available at all in existing cell line connections. The new models reportedly will have the potential to reflect the biology of tumors more accurately and better represent the overall cancer patient population.

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