Drugs

BMS/Juno FDA-483 Response to Liso-cel Inspection

FDA has posted an 11/5/2020 Form FDA-483 response from Bristol-Myers Squibb/Juno Therapeutics that addressed an FDA-483 with six inspection observations issued following a 10/2020 agency inspection at Juno in Bothell, WA. The firm is a CAR-T cell therapy manufacturer and the inspection was a pre-license inspection for JCAR017 (lisocabtagene maraleucel), indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The FDA-483 response addressed the following specific inspection observations:

failing to thoroughly review any unexplained discrepancy, failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failing to include appropriate conclusions and follow-up in written records of investigations into unexplained discrepancies or the failure of a batch or any of its components to meet specifications;
failing to include required materials in the written procedure for manufacturing material visual inspection;
failing to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
failing to justify deviations from written test procedures to assure compliance with established specifications and standards.

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