Drugs

Bill to Use Industry Penalties for Cancer Research

Bipartisan legislation to use penalties paid by drug, cosmetic, supplement, and medical device companies to increase childhood cancer research has been introduced by Sens. Tim Kaine (D-VA), Jerry Moran (R-KS), and Mark Warner (D-VA). A version of the bill has also been introduced in the House by Rep. Jennifer Wexton (D-VA). The bill would redirect penalties collected from companies that break the law to pediatric and childhood cancer research.

A statement from Sen. Kaine says the Gabriella Miller Kids First Research Act 2.0 would provide the new source of funding for the National Institute of Health’s Gabriella Miller Kids First Pediatric Research Program, which Kaine helped to create in 2014 to honor the Leesburg, VA, resident who died in 2013 at age 10 from a rare form of brain cancer.

The program has supported critical research into pediatric cancer and structural birth defects, Kaine says, and has focused on building a pediatric data resource combining genetic sequencing data with clinical data from multiple pediatric cohorts.

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

Read more

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