Drugs

Journal Investigates Vaccine Study

A clinical trial in South African infants of an improved vaccine for tuberculosis is the subject of an investigational report in The BMJ. The report says the children’s parents committed to the trial based on information that included the statement that the trial vaccine “has been tested in animals and was shown to be safe and effective.”

Similar statements were used to obtain funding and ethical and regulatory approval for the trial, the report says. The investigation voices concern about how the Oxford University researchers used the results of animal studies selectively to gain funding and approval for human trials.

“The investigation asks whether the parents of babies included in the South African trial were misled and raises questions about the transparency around regulatory decision making and what data are required when deciding to move from animal studies to human trials,” the study says. “It also asks if universities are equipped or willing to investigate allegations of scientific misconduct against high profile academics who bring in substantial funding.”

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