Drugs

Companies Comment on Esophagitis Drug Development

Regeneron says it welcomes FDA efforts to provide recommendations in a draft guidance regarding clinical trials for drugs and therapeutic biologics to treat eosinophilic esophagitis (EoE). “As a rare disease,” the company’s comment says, “eosinophilic esophagitis is currently without a clear precedent for requirements for regulatory approval. We understand the need for clear guidance for the development of new therapeutics for this disease, which would include details on the following: attributes of patients for enrollment, efficacy assessments, safety assessments, and pediatric considerations. While it appears that this draft guidance is consistent with current adult/adolescent EoE study design concepts followed by industry, we propose that the development of a regulatory guidance presents an opportunity for the agency to advance the discussion of EoE drug development to assist sponsors in developing new and effective and safe therapies that provide clinically meaningful improvements in the lives of patients suffering from this complex disease.”

Regeneron gives its views on pediatric study design and recommendations, rationale for randomized withdrawal designs, objective measures, and additional agency engagement.

In its letter, Celgene offers its comments and recommendations on the definition of histologic response, proposed criteria for trial population, efficacy considerations, and clinical outcome assessments outlined in the draft guidance. It says it is “pleased to see the agency’s commitment to advancing the principles of innovation in product development for 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