Biologics

FDA Rejects Gilead Hepatitis Delta BLA

FDA has issued Gilead a complete response letter on its BLA for bulevirtide, an investigational entry-inhibitor for treating adults with hepatitis delta virus (HDV) infection and compensated liver disease. FDA’s letter cited concerns about the “manufacture and delivery of bulevirtide,” according to the company, adding that no new studies to evaluate the safety and efficacy of bulevirtide have been requested.

“Since the acquisition of MYR GmbH and bulevirtide in 2021, Gilead has been working to implement process improvements to the manufacturing of bulevirtide,” the company says. “Gilead will continue to discuss manufacturing and product delivery improvements with the FDA.”

The company says that chronic HDV infection is the most serious viral hepatitis form, and carries with it poor prognoses and high mortality rates. Previously the agency granted the therapy breakthrough therapy and orphan drug designations. It is currently conditionally authorized in certain European countries under the tradename Hepcludex.

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