Drugs

FDA Mostly Positive on Teplizumab

FDA says Provention Bio’s teplizumab Type 1 diabetes treatment successfully demonstrated its treatment effect in delaying diagnosis of Type 1 diabetes in at-risk patients. The assessment is in a briefing document released by the agency in advance of the 5/27 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee that will consider Provention’s BLA for teplizumab, described as an FeR-nonbinding anti-CD3, humanized monoclonal antibody.

The briefing document says the treatment effect was “statistically significant and robust to sensitivity analyses under a range of conservative assumptions for missing data.” It also said the amount of missing data was small.

The agency asks the committee to discuss the overall evidence provided in support of the requested indication, the clinical meaningfulness of an observed median two-year delay in onset of Type 1 diabetes demonstrated in the submitted study, safety issues identified in the clinical development program, and to recommend whether the drug’s benefits outweigh the risks and support approval for the proposed indication.

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