Biologics

Glaxo’s Boostrix OK’d for Unborn in Third Trimester

FDA has approved GlaxoSimthKline Biologicals’ Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis (whooping cough) in infants younger than two months of age.

Most serious pertussis cases, hospitalizations and deaths occur in infants younger than two months of age who are too young to be protected by a vaccine, FDA says in a news release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy,” it notes.”

“The determination of effectiveness of Boostrix administered during the third trimester to prevent pertussis among infants younger than two months of age was based on a re-analysis of the Boostrix-relevant data from an observational case-control study of Tdap vaccine effectiveness,” the agency says. “The FDA found these real-world data as providing real-world evidence to support this approval. In this re-analysis, data from 108 cases of pertussis in infants younger than two months of age (including four cases whose mothers received Boostrix during the third trimester) and 183 control infants who did not have pertussis (including18 whose mothers received Boostrix during the third trimester) resulted in a preliminary estimate of Boostrix as 78% effective in preventing pertussis among infants younger than two months of age, when administered during the third trimester of pregnancy.”

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