Biologics

Predictive Biotech Selling Unapproved Covid Cures: FDA

FDA says Web sites and social media posts for Predictive Biotech, Salt Lake City, UT, promote sales of CoreCyte, an umbilical cord-derived product, to mitigate, prevent, treat, diagnose, or cure Covid-19. An 8/17 Warning Letter says CoteCyte is a human cell, tissue, or cellular or tissue-based product and is considered to be a misbranded unapproved new drug as well as a biological product that requires a BLA or IND. CoreCyte does not have either a BLA or an IND in effect, the letter says.

The letter says FDA has not issued an emergency use authorization to permit the emergency use of CoreCyte under any circumstances.

Predictive was told to take immediate action to correct the violations. “We advise you to review your Web sites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product as safe and effective for a Covid-19 related use for which it has not been licensed by FDA and that you do not make claims that misbrand the product in violation of the Federal Food, Drug, and Cosmetics Act,” the letter says. “We request that you alert any customers to whom you marketed CoreCyte for use in the treatment or prevention of Covid-19 that the product is not authorized by FDA for such use.”

The company was told to respond by e-mail within 48 hours listing specific steps it has taken to correct the violations and prevent their recurrence, with copies of related documentation.

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