Drugs

Child Cancer Research Bill Reintroduced

The Give Kids a Chance Act, legislation that would provide children greater access to cancer trials and therapies, has been reintroduced by Reps. Anna Eshoo (D-CA) and Michael McCaul (R-TX). It has 12 bipartisan cosponsors.

A statement (includes a link to the bill text) from Eshoo says the bill would authorize FDA to direct drug companies to conduct pediatric cancer trials on combination therapies. It says the vast majority of pediatric cancer trials are currently conducted on kids with relapsed cancer and FDA is only authorized to direct pediatric cancer trials of single drugs.

“Unfortunately,” it says, “children with relapsed cancer are rarely cured by one-drug treatments because their cancers are so advanced. Thousands of successful drug combination therapies are now being studied and developed for adults, but not for children.”

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