Biologics

Develop Regulatory Framework for Synthetic Cells: Paper

Three people who work in the artificial cell industry say FDA has not yet begun to develop a regulatory framework for artificial cell technologies. “Such lack of preparation for what could be the next forefront of medicine could largely delay the development of these therapies,” the three write in a Stat News column.

The post lists the advantages synthetic, non-living cells have over natural cell therapies. They are easier to manipulate and redesign, it says, and their simpler biochemical frameworks and hand-selected biomaterials make it possible for them to more accurately target cells, tissues, and pathogens.

“While synthetic cells could someday be powerful tools to advance medical care,” the article says, “no legislation currently exists to regulate this technology. “Developers of synthetic cell therapies can proactively address current regulatory gaps by following practices pharmaceutical companies have previously used with similar engineered bioproducts such as CAR-T cell therapy….” The authors say that developers of synthetic cell therapies should engage with FDA early and begin to proactively generate plans for every step of testing and production.

“The development of synthetic cell therapies needs to occur in tandem with a focus on future FDA approval and safety,” the post concludes. “Before the first synthetic cell therapy enters human trials, plans and strategies should be in place for overcoming the limitations of the current FDA approval pipeline. Without that regulatory work, the future of these revolutionary therapies could be stalled, or even derailed.”

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