Biologics

Xbrane Refiles Lucentis Biosimilar BLA

Xbrane Biopharma has resubmitted a BLA for its investigational ranibizumab, a biosimilar copy of Genentech’s Lucentis, which is indicated for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Ranibizumab is an anti-vascular endothelial growth factor therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults.

Xbrane originally submitted the BLA 4/2023 and received a complete response letter a year later. In the letter, the agency requested additional information related to the reference standard and follow-up actions from the pre-approval inspections of manufacturing partners’ sites. “Xbrane has since, after alignment with FDA, qualified a new reference standard and worked together with its manufacturing partners to complete the requested follow-up actions,” the company says, noting that the review cycle of a re-submitted BLA is six months.

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