Drugs

1st Patient Being Treated Under Right-to-Try Law

An unidentified California man with glioblastoma, the same deadly form of brain cancer that claimed the life of Sen. John McCain (R-AZ) last year, is the first patient to receive an experimental therapy under the so-called “Right-to-Try” law that was signed into law in 5/2018 by President Trump, according to Bloomberg. The treatment, called Gliovac, is a vaccine manipulated from the patient’s own cells and tissue taken from other patients with glioblastoma. It’s being provided to the man by Epitopoietic Research Corp., a closely-held Belgian company that is testing it in human trials.

The patient’s family went to the company to request the therapy after he didn’t qualify for the experimental study of Gliovac or any other trial that was underway, Bloomberg reports. So far about 30 patients have been treated with Gliovac, mainly in clinical trials and a compassionate use program in Europe. Many patients in the U.S. don’t qualify for the study now underway at the University of California, Irvine, School of Medicine because of the severity of their condition or other unapproved treatments they have tried, a researcher told the news service.

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