Biologics

Complete Response Letter for 4-Dose Heplisav-B

FDA has issued a complete response letter to Dynavax Technologies for its sBLA for a four-dose Heplisav-B vaccine (hepatitis B vaccine [recombinant] adjuvanted) regimen for adults on dialysis. A company statement says FDA said the application did not provide sufficient data to support the full evaluation of the effectiveness or safety of the four-dose regimen.

The letter says data from the Phase 1 HBV-24 trial were insufficient due to the destruction of data source documents by a third-party clinical trial site operator for about half the subjects enrolled in the trial, Dynavax says. In addition, it says, the total number of subjects in the single-arm study was deemed to be insufficient to evaluate the safety of the four-dose regimen.

The company says it plans to request a meeting with FDA to evaluate the options for providing additional data to support the four-dose regimen for the dialysis population.

Heplisav-B is currently indicated to prevent infection caused by all known subtypes of hepatitis B virus in adults aged 18 and older.

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