Biologics

ADMA Bio Gets Complete Response Letter on BLA

FDA has given ADMA Biologics a complete response letter for a BLA for RI-002, an investigational therapy for treating primary immunodeficiency (PI) patients. The letter identified certain outstanding inspection issues and deficiencies at ADMA’s third-party contract manufacturers, including its contract drug substance and product manufacturer, and its contract fill and finisher, according to the company. It also cited compliance issues with a third-party contract testing laboratory, and requested documentation of corrections for a number of the issues, it says.

ADMA says it has been informed by its third-party drug substance and product manufacturer that it is working to resolve the outstanding inspection issues. The company says it will monitor their efforts in addressing and resolving outstanding issues relating to the observations. It also says it will work with the agency to reach an agreement on acceptable language for the package insert and container and vial labeling, if and when approval is granted.

PI is a class of inherited genetic disorders that cause an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly, the company says. It affects about 250,000 people in the U.S.

RI-002 is a specialty plasma-derived, polyclonal, intravenous immune globulin derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus, measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus, according to ADMA. “Data review indicates that the polyclonal antibodies present in RI-002 support its ability to prevent infections in immune-compromised patients,” it says.

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