Drugs

CBER Joining Lupus Research Consortium

FDA is expanding its partnership with the Lupus Research Alliance (LRA) by including CBER in the Lupus Accelerating Breakthroughs Consortium (Lupus ABC). LRA says the addition of CBER to Lupus ABC “will enhance the consortium’s focus on engineered cell therapies, a promising new area in therapeutic development.” Lupus ABC was launched in 3/2023 with CDER.

Lupus ABC is described as a first-of-its-kind public-private partnership joining individuals with lupus and their advocates, industry, clinicians, researchers, and government stakeholders to collaboratively identify and pursue the most effective ways to accelerate the development of personalized treatments for people with lupus.

The LRA statement says that since its launch, Lupus ABC has made robust progress by building a strong community of more than 40 member groups and launching three projects focused on different outcome measures for lupus trials. It says that a fourth project, centering on CAR-T cells, will include essential representation from CBER.

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