Drugs

FDA Signals NDA Path for Virpax Nasal Anti-viral Barrier

FDA has told Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray under development for use as an anti-viral barrier product intended to intranasally limit transmission of the viruses to others. The company says FDA indicated that it may pursue an NDA with the agency’s Office of Non-Prescription Drugs, and it has retained Syneos Health to assist with clinical trial designs.

Virpax previously reported that it had completed in-vitro, ex-vivo (human mucosal cells) and in-vivo trials involving MMS019, which demonstrated inhibition of viral replication of SARS-CoV-2 and influenza in animals at much higher ranges than what is encountered by humans in the nasal passages. “In addition to inhibition of viral replication, the animal studies also demonstrated decreased levels of the virus in animal brain tissue, a potentially important observation as recent studies have shown neurological conditions with survivors of severe Covid,” it says.

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