Drugs

FDA, Alliance Launch Lupus ABC

FDA and the Lupus Research Alliance have launched the Lupus Accelerating Breakthrough Consortium (Lupus ABC) focused on addressing challenges affecting lupus clinical trial success. An agency announcement says Lupus ABC “will convene people living with lupus, medical societies, industry, academic clinical researchers and scientists, FDA, and other federal agencies to address scientific hurdles that are beyond the capacity of any single entity. By connecting those with lived experience with all parties involved in lupus treatment research, CDER hopes to advance the development of urgently needed treatments for lupus.”

The notice says Lupus ABC will provide a forum to define common challenges in drug development and facilitate approaches that will have the most immediate impact on advancing therapeutic development for lupus. Initially, it says, these efforts will focus on:

better evaluate the impact of potential treatments by refining existing measurement tools that clinical research has shown may not always adequately assess a drug’s effectiveness; and
fully incorporate the patient voice into the drug development process by optimizing patient-reported outcome measures, enabling recognition of the impact of potential treatments on specific symptoms that matter most to patients.

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