Biologics

Liveyon Founder Pleads Guilty

Liveyon founder and CEO John Kosolcharoen pleaded guilty on 8/26 to a felony violation of the Federal Food, Drug, and Cosmetic Act by introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. A Department of Justice statement says he is currently in custody serving a sentence for a separate unrelated conviction.

Court documents indicate that Kosolcharoen founded Liveyon and Genetech in 2016 to manufacture and distribute injectable stem cell products made from human umbilical cord blood. The products were marketed under several brand names including ReGen, the statement says.

In his plea agreement, Kosolcharoen admitted that he and others misrepresented ReGen as suitable to treat conditions such as lung and heart diseases, autoimmune disorders, Alzheimer’s disease, Parkinson’s disease, and others.

He also admitted that to mislead FDA about Liveyon’s activities, he directed that purchase orders falsely state that the stem cell products were sold for research purposes only.

The statement says that in 2018 FDA and the Centers for Disease Control received reports of patients in multiple states requiring hospitalization for bacterial infections after receiving Liveyon products. Kosolcharoen said that he and others fraudulently induced customers into purchasing stem cell-derived Liveyon products by misleading the public about the cause and severity of adverse events suffered by patients and falsely reporting and concealing material facts about the outcome of an FDA inspection at Genetech that found significant deviations from good manufacturing and tissue practices.

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