Drugs

FDA Accepts Autolus Obe-Cel BLA

FDA has accepted for review an Autolus Therapeutics BLA for obecabtagene autoleucel (obe-cel) as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukemia. A company statement says FDA has set a PDUFA target action date of 11/16.

The submission is based on data from the pivotal Phase 2 FELIX study of obe-cel in relapsed/refractory adult B-cell acute lymphoblastic leukemia. The drug has been granted FDA orphan drug designation and regenerative medicine advanced therapy.

Obe-cel is described as a CD19 CAR T-cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T-cell therapies. It is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells.

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