Drugs

New Diabetes Draft Guidance is ‘Step Backward’: Professor

University of Washington professor of medicine and epidemiology Bruce Psaty says an FDA draft 2020 guidance on evaluating the safety of new drugs for improving glycemic control “represents a serious step backward.” Writing in a comment letter, Psaty says an earlier 2008 guidance “revolutionized the quantity and quality of information about the risk/benefit profile of drugs approved to treat Type 2 diabetes” and should be continued.

In its letter, AstraZeneca says, “With regard to an overall evaluation of safety for the development of drugs and biologics indicated for improvement of glycemic control in patients with Type 2 diabetes, an excess risk of weight gain or even weight neutrality should be avoided when there are existing therapies which provide weight loss.” The company also makes line-by-line suggested revisions.

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