Drugs

Biocon Gets Insulin Aspart BLA Rejection

FDA has issued Biocon Biologics a complete response letter on its BLA for insulin aspart. While the letter did not identify any outstanding scientific issues with the product, the company did say it references a requirement for a “satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for insulin aspart, held in August 2022.”

Biocon says it submitted a comprehensive corrective and preventive action (CAPA) plan last month that the agency reportedly found to be adequate. FDA indicated that it would require a re-inspection of the Malaysia facility prior to the BLA’s approval, it adds.

Additionally, Biocon says that in February a report from an independent third-party consultant was submitted that provided evidence of the CAPA plan’s completion and effectiveness. However, a pre-approval reinspection was not scheduled prior to the user fee goal date of 10/6, it says, adding that the company will continue to engage with FDA to seek an “expeditious resolution and approval.”

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