Biologics

FDA Complete Response on Green Cross Immunoglobulin

FDA has issued Green Cross Corp. a complete response letter on its BLA for IVIG-SN (human normal immunoglobulin G for intravenous administration), intended for treating primary immunodeficiency diseases. The letter asks for additional information related to chemistry, manufacturing and controls, according to the company, and it did not cite efficacy or safety issues. Green Cross says the issues can be addressed and it is working on a timely response to the agency.

The submission included data from a Phase 3 study that met its primary endpoint of no acute serious bacterial infections. “These results, included in the submission, were well under the requirement specified by the FDA guidance of no more than one acute serious bacterial infection per patient-year,” the company says.

Green Cross, with headquarters in South Korea, says it is the largest plasma protein products manufacturer in Asia. It has been marketing IVIG-SN in more than 30 countries in Asia, South America and the Middle East.

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