Drugs

Outlook Therapeutics Refiling BLA in September

Outlook Therapeutics has withdrawn a BLA submitted in March for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration (wet AMD). FDA has requested additional information before it will accept the filing, the company says, adding that it plans to resubmit the BLA in September. “If approved, Lytenava could replace the current practice of using unapproved repackaged IV [intravenous] bevacizumab sourced from compounding pharmacies for the treatment of wet AMD,” the company says.

The submission was based on data from the company’s NORSE ONE and TWO and Phase 3 pivotal trials. It also includes integrated safety data from the NORSE registration clinical program. “We observed a total of one ocular inflammation adverse event (iritis) reported from our three completed NORSE clinical studies,” the company says.

Bevacizumab is a recombinant humanized monoclonal antibody that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to certain receptors, according to the company. It was first approved in 2004 as Genentech’s Avastin as a first-line treatment for patients with metastatic colorectal cancer.

Outlook Therapeutics has entered into a partnership with FujiFilm Diosynth Biotechnologies for drug substance manufacturing, and with Aji Biopharma Services for finished drug product manufacturing.

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