Biologics

Judge Approves StemGenex Client Settlement

A California federal judge has approved a $3.65 million settlement with 1,063 former clients of StemGenex, a La Jolla, CA, stem cell clinic, and its former chief medical officer. The clients’ class-action suit filed in 2016 alleged that they were misled by StemGenex advertising and promotional materials claiming that its treatment was effective against numerous conditions including lupus, diabetes, multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease, the Los Angeles Times reports.

The report says class members will each receive about $1,936 from the settlement fund, with the remainder going to legal fees and expenses. Their suit claimed StemGenex charged $14,900 per treatment. The suit says none of the plaintiffs received “any significant benefit” from the treatment.

The Times says FDA has approved stem cell treatments only for certain blood-related conditions, and then only with stem cells from umbilical cord blood. The agency has cautioned consumers against accepting any other claims for stem cell therapies, saying they are “illegal and potentially harmful.”

In 10/2018, the report says, FDA sent StemGenex a “lengthy” Warning Letter saying that it was marketing an illegal drug. The letter also said the firm’s sanitary and sterilization procedures raised “potential significant safety concerns.”

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