Biologics

FDA Approved 2 Gene Therapies, 3 Vaccines in 2018: CBER

CBER director Peter Marks says one of the highlights for FY 2018 was approval of two gene therapies and three vaccines. The Center’s annual report from the director says the gene therapies were Luxturna, the first directly-administered gene therapy for a specific genetic disorder (an inherited retinal disease), and Yescarta, a cell-based gene therapy for certain types of adult large B-cell lymphoma.

Vaccines approved in FY 2018 were Heplisav-B, a hepatitis B vaccine to prevent infection caused by all known subtypes of hepatitis B in adults aged 18-70, the Shingrix shingles vaccine for adults age 50 and older, and Fluarix Quadrivalent, to prevent influenza disease in children as young as six months.

The Center also granted an emergency use authorization to the Defense Department to ensure use of freeze-dried plasma to treat hemorrhage or coagulopathy of U.S. military personnel injured during combat when plasma is not available or its use is not practical.

Marks says CBER met or exceeded PDUFA 6 and MDUFA expectations and initiated or completed efforts on behalf of the 21^st Century Cures Act, including patient experience in regulatory decision-making, providing grants to research institutions, drafting guidances for regenerative medicines, and contributing to a guidance on antibacterial and antifungal drug development.

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