Drugs

Pfizer Plans BLA for RSV Vaccine

Pfizer says it will file by year end a BLA for its investigational bivalent respiratory syncytial virus (RSV) vaccine after stopping enrollment in a Phase 3 study that it says showed favorable results. In the study, the vaccine was administered to pregnant participants to protect their infants from RSV after birth. The contagious virus is a common cause of respiratory illness, which can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for young infants and older adults.

The company says that during the MATISSE study “vaccine efficacy of 81.8% was observed against severe medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life with high efficacy of 69.4% demonstrated through the first six months of life…Pre-planned safety reviews conducted at regular intervals throughout the duration of the study by the [data monitoring committee] DMC also indicate the investigational vaccine is well-tolerated with no safety concerns for both the vaccinated individuals and their newborns.”

Pfizer says a "maternal vaccine with high efficacy that can help protect infants from birth could substantially reduce the burden of severe RSV among newborns through six months of age, and, if approved by regulatory authorities, will likely have a significant impact on disease in the U.S. and globally.”

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