Biologics

FDA Using Emulate to Evaluate Covid Vaccine Safety

FDA has entered into a Cooperative Research and Development Agreement with Emulate, Inc., to enable multiple studies across FDA Centers in priority research areas, including programs to evaluate Covid-19 vaccines and understand human response against SARS-CoV-2. Emulate says that under the agreement the agency will use a range of its organ-chips to study the safety, efficacy, and mechanisms of drugs it regulates. The new agreement follows the successful completion of a 2017 agreement that focused on toxicity studies using the firm’s liver-chip.

“The initial studies use organ-chips, which are able to recreate the natural physiology of specific human tissues and organs, in areas where conventional cell culture and animal-based testing methods have limitations in reflecting human biology and disease mechanisms that are not yet understood, such as Alzheimer’s disease and Covid-19,” Emulate says.

The CBER Covid-19 study will look at why individuals experience a wide spectrum of disease severity and what constitutes real protection against future infection, the statement says. It says the Emulate human lung-chip that will be used recreates the microenvironment found in a human lung.

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