Drugs

Bipartisan Brain Cancer Research Bill In

Sen. Richard Blumenthal (D-CT) and Rep. Brian Fitzpatrick (R-PA) have introduced the Bolstering Research and Innovation Now (BRAIN) Act to advance research for brain cancer and improve brain tumor treatment and care. A statement (includes links to the bill text) issued by Blumenthal lists three bipartisan Senate co-sponsors and three bipartisan House co-sponsors.

Blumenthal says the legislation “takes a comprehensive, complementary approach to reduce mortality rates and make meaningful progress against brain tumors.” He says the bill specifically would:

direct FDA to issue guidance to ensure brain tumor and other rare and recalcitrant cancer patients have access to clinical trials evaluating treatments for other diseases;
increase transparency of federally-funded biobank collections so that researchers are aware of others who possess samples that might be shared to enable important research;
provide sufficient resources to the National Cancer Institute’s Glioblastoma Therapeutics Network so that it can realize its promise of vetting treatments and completing innovative early-phase clinical trials;
enable team science to advance immunotherapy research (CAR-T) engineered to attack brain cancer cells;
directs the Centers for Disease Control to conduct a public education campaign around the importance of clinical trials and biomarker testing in cancer treatment; and
augment and expand funding to develop innovative systems of care models for brain tumor survivors.

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