Biologics

Cell2in Asks FDA OK for Glutathione Monitoring for BLAs

In a 5/20 petition, Seoul, Korea, biotechnology company Cell2in is asking FDA to update applicable guidances to identify real-time glutathione monitoring methods as an acceptable means of measuring potency for purposes of submitting a BLA for cell-based therapies, including stem cell therapies. The petition says it is focused on the critical quality of potency and says it is not possible to overstate the importance of assessing a cellular therapy product’s potency.

“Without an accurate assessment of potency,” the petition says, “there is simply no guarantee that the product will have the desired therapeutic effect in patients.”

Cell2in says it is identifying a method for real-time monitoring of intracellular glutathione in living cells as an assay that cell-based therapy researchers and sponsors can use to measure product potency. The petition says the assay uses intracellular glutathione as a proxy for cells’ antioxidant capacity, functionality, and “stemness” (a measure of stem cells’ ability to self-renew, proliferate, and differentiate) without consuming the cells’ glutathione.

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

Read more

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