Drugs

CSL Behring’s Zemaira OK’d for Larger Vials

FDA has approved CSL Behring’s four- and five-gram vial sizes for Zemaira [alpha1-proteinase inhibitor (human)], its therapy for treating Alpha 1 Antitrypsin Deficiency. Previously, Zemaira was available only in a one-gram vial, and the new sizes reduces the number of vials necessary for reconstitution, the company says. The natural Alpha 1 protein is derived from human plasma, which CSL Behring says has been shown to raise and maintain serum levels of alpha 1 antitrypsin (AAT) protein in patients. Alpha 1 Antitrypsin Deficiency is a hereditary condition that can severely affect a patient’s lung function, it says. The condition is marked by a low level or absence of AAT, a natural protein that inhibits neutrophil elastase which prevents destruction of lung tissue.

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