Drugs

GSK Positive Data from Respiratory Virus Vaccine Trial

GSK has announced positive data from a pre-specified efficacy interim analysis of its AReSVi 006 Phase 3 trial evaluating the company’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above. The analysis found that the primary endpoint was exceeded with no unexpected safety concerns reported. GSK says the trial will continue to evaluate both an annual revaccination schedule and longer-term protection over multiple seasons following one dose.

The vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen combined with GSK’s proprietary AS01 adjuvant, which is used with several of the company’s established adjuvanted vaccines. “The antigen plus adjuvant combination may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting older adults from RSV disease,” GSK says.

RSV is a common contagious virus affecting the lungs and breathing passages. The company says it is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment. Older adults are at high risk for severe disease, and RSV can exacerbate conditions including chronic obstructive pulmonary disease, asthma and chronic heart failure, 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

Read more

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