Drugs

Fast Track for Staph Aureus Pneumonia Therapy

FDA has granted Arsanis fast track status for ASN100 for preventing Staphylococcus aureus pneumonia in mechanically ventilated patients who are at high risk for the condition. “Despite current antibiotic treatments, S. aureus pneumonia has a mortality rate as high as 30% in this patient population, according to the company.

ASN100 is a combination of two fully human monoclonal antibodies that collectively neutralize six S. aureus cytotoxins associated with pneumonia pathogenesis. ASN-1 neutralizes alphahemolysin, a key S. aureus toxin responsible for lung epithelial cell damage, in addition to four S.aureus leukocidins responsible for lysis of human phagocytic (immune) cells, the company says. ASN-2 inactivates the remaining S.aureus leukocidin, LukGH, which is a potent human cytotoxin that is also responsible for lysis of human phagocytes.

Arsanis has recently completed a Phase 1 clinical study of ASN100, and plans to begin dosing patients in a Phase 2 study later this year.

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