Drugs

Changes Sought in FDA Diabetes Endpoint Guidance

AstraZeneca says an FDA draft guidance on efficacy endpoints for clinical trials investigating antidiabetic drugs and biological products, when combined with a 2020 guidance, appears to cover substantially less material than the 2008 guidance it replaces. In a comment letter, the company suggests that the agency consider including in the new draft a reference to where sponsors can find guidance on pharmacokinetic/pharmacodynamic considerations, weight loss, metabolic syndrome, important statistical considerations, randomized withdrawal, and guidance on fixed-dose combinations and other topics that are not covered.

In its response, Pfizer says that hypoglycemia prevention is an important element of diabetes management in pediatric patients and thus the number and severity of hypoglycemia events are important endpoints of disease management and the assessment of treatment option efficacy. “We suggest including hypoglycemic level 1 as an acceptable endpoint for young pediatric patients,” it says.

Sanofi submitted line-by-line technical comments.

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