Drugs

Elevar Resubmitting Cancer Drug NDA

Elevar Therapeutics says it will soon resubmit its NDA for rivoceranib in combination with camrelizumab as a first-line treatment option for unresectable hepatocellular carcinoma. A company statement says the resubmission follows a 7/2 Type A meeting with FDA that addressed items in the agency’s 5/16 complete response letter.

The letter cited good manufacturing practice deficiencies at the Hengrui Pharma facility where camrelizumab is manufactured and incomplete bioresearch monitoring inspections due to FDA travel restrictions. FDA did not reference any issues related to clinical data or with the rivoceranib manufacturing site, the statement says.

Camrelizumab is a humanized monoclonal antibody that binds to the programmed death-1 receptor. FDA granted it orphan drug designation for hepatocellular carcinoma in 4/2021. Rivoceranib, a small-molecule tyrosine kinase inhibitor is said to be a highly potent inhibitor of vascular endothelial growth factor receptor 2, a primary pathway for tumor angiogenesis. FDA has given it an orphan drug designation for gastric cancer, adenoid cystic carcinoma, and unresectable hepatocellular carcinoma.

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