Biologics

CBER Approved Gene Therapy, 3 Vaccines in 2019

CBER director Peter Marks’ annual report for FY 2019 says the Center approved a novel gene therapy, vaccines, treatments for immune deficiencies, and tests for protection of the blood supply, among other products. The Center approved Zolgensma, the report says, a gene therapy for pediatric patients less than two years old with spinal muscular atrophy caused by a specific genetic mutation. It also approved three vaccines — Dengvaxia, to prevent dengue disease in individuals nine through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas; Jynneos, to prevent smallpox and monkeypox disease in adults age 18 and older who are at risk for either infection; and Vaxelis, to prevent diphtheria, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenza type b, for use in children six weeks through four years of age.

Also approved were three treatments for immunodeficiency — Xembify, for patients age two and older; Asceniv, for adults and adolescents 12 to 17 years old; and Cutaquig, for adults.

CBER also says it supported new product development by helping to manage and support the Complex Innovative Designs pilot program that enabled close collaboration with CDER to devise and disseminate a process for reviewing complex and innovative clinical trial designs. And it advanced work on the Biologics Effectiveness and Safety post-market surveillance infrastructure, which significantly reduced the lag time to identify potential adverse events from approved products using claims data, electronic health records (EHR), and linked claims-EHR databases.

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