Biologics

Atara Bio Plans BLA for Tabelecleucel

Atara Biotherapeutics says it expects to file by 7/2024 a BLA for tabelecleucel, an allogeneic, Epstein-Barr virus (EBV)-specific T-cell immunotherapy that targets and eliminates EBV-infected cells in a human leucocyte antigen-restricted manner. The company says it recently achieved agreement with FDA on the company’s analytical comparability between manufacturing process versions. “This alignment supports Atara's ability to pool the pivotal clinical trial data from different process versions in the BLA submission,” it says.

Atara says Epstein-Barr virus-positive post-transplant lymphoproliferative disease is a rare and potentially deadly hematologic malignancy that occurs when patient T-cell immune responses are compromised by immunosuppression. Tabelecleucel is marketed by Pierre Fabre in Europe since 12/2022 under the tradename Ebvallo.

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