Biologics

FDA Identifies Deficiencies in Provention BLA

FDA has told Provention Bio that it has identified deficiencies with its BLA for diabetes therapy teplizumab that preclude labeling and post-marketing requirements/commitments discussions at this time. The agency’s notification stated the deficiencies do not reflect a final decision on the information under review, the company says. Additionally, the review concerns are not precuding the agency from continuing with a planned 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting, according to Provention.

FDA also informed the company that it had completed its review of data and an analysis submitted for its single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study. “This study evaluated the PK/PD comparability of drug product originating from drug substance manufactured by AGC Biologics, which the company plans to use for commercialization, and drug product originating from historic drug substance manufactured by Eli Lilly used for the TN-10 study submitted for the teplizumab BLA,” the company says. “The FDA indicated that based on the data it has reviewed to date, the agency's position is that the PK profiles of the two drug products evaluated in the PK/PD bridging study were not comparable and that additional data would be required before the FDA's considerations could be satisfied. As a follow up, today, the FDA stated to the company that it is willing to discuss these issues concurrently with its ongoing review.”

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