Drugs

FDA Lifts Partial Hold on Bluebird Bio Lovo-Cel Study

FDA has lifted its partial clinical hold for patients under age 18 in studies evaluating Bluebird Bio’s lovotibeglogene autotemcel (lovo-cel) for sickle cell disease. A company statement says the agency placed the studies on a partial hold for patients under age 18 in 12/2021 relating to a company investigation into an adolescent patient with persistent, non-transfusion-dependent anemia following treatment with lovo-cel.

Bluebird says its study of two patients with persistent anemia determined that they had two a-globin gene deletions, known as alpha-thalassemia trait, and the genotype was added to exclusion criteria for ongoing studies.

The company says it is working to resume enrollment and treatment of patients aged 2-17 consistent with the study protocol and remains on track to submit a BLA in the first quarter of this year.

FDA has granted orphan drug, fast track, regenerative medicine advanced therapy, and rare pediatric disease designations for lovo-cel, Bluebird says.

Lovo-cel gene therapy is described as an investigational one-time treatment being studied for sickle cell disease that is designed to add functional copies of a modified form of the β-globin gene into a patient’s hematopoietic stem 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