Drugs

Share All Cancer Drug Approval Data: Study

Researchers in the U.S. and Australia say that while there has been a substantial increase in individual participant data (IPD) sharing for industry-sponsored oncology trials in the past five years, much more needs to be done. An investigation published in JAMA Oncology found that of the 304 trials that underpinned FDA registration of 115 anticancer medicines over the past 10 years, 45% were eligible for IPD sharing but 55% were not eligible.

“Although inroads have been made toward improving IPD transparency over the past five years,” the article says, “these findings suggest that a substantial portion of pivotal oncology trials that support the FDA registration of modern anticancer medicines remain unavailable to qualified researchers…. Because these trials form the basis of safety and efficacy claims for new medicines, we question whether it is justified that the data are unavailable to independent scrutiny. On the basis of our findings, we reiterate calls that transparency policies need updating so that all IPD that inform results presented in a product label or underpin drug registration are immediately eligible for sharing.”

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