Drugs

FDA, C-Path Exploring Lysosomal Diseases Group

FDA says it is partnering with the Critical Path Institute (C-Path) to explore the feasibility of launching a Lysosomal Diseases Consortium. An agency post says the consortium would be a public/private partnership among FDA, leading academic institutions, pharmaceutical industries, patient groups, and non-government organizations to address unmet drug development needs for patients living with lysosomal diseases.

The consortium would be under the umbrella of the Accelerating Rare Disease Cures program and would focus on generating actionable solutions to accelerate drug development for lysosomal diseases and ensuring that the solutions reflect current scientific knowledge of the diseases and regulatory standards for implementing drug development.

As part of the exploratory phase, FDA says, C-Path will start a one-year effort to determine the feasibility of ensuring a sustainable operational consortium. Key stakeholders will be brought together to conduct a comprehensive landscape analysis of the ecosystem of lysosomal diseases, it says. Through their collective input and feedback, it says, the group will help determine the high-level goals and objectives, generate a research plan to focus on identified common unmet medical product development needs, and develop operations and governance plans for the envisioned consortium.

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