Biologics

Feds Should Make Covid Vaccine Affordable to All: Report

Public Citizen says the U.S. government may jointly own Moderna’s mRNA-1273, a leading Covid-19 vaccine candidate, and should use that ownership to make the vaccine affordable to all in plentiful supply if it is demonstrated to be safe and effective. A report issued by the advocacy organization says Public Citizen found two patent application disclosures by federal scientists likely concerning the Moderna candidate.

“Recent agreements between Moderna and the National Institutes of Health, reported by Axios, suggest that the government has a stake in the potential vaccine,” a Public Citizen statement says. “These applications and collaboration agreements likely show the U.S. government will co-own important patents on mRNA-1273, so long as those patents are granted, giving the government significant rights over a potential Covid-19 vaccine.”

The report suggests that the federal government condition Moderna’s use of essential U.S. patented vaccine interventions on reasonable pricing and ensuring sufficient supply. “Globally, the U.S. government should share its intellectual property and know-how with the World Health Organization’s Covid-19 technology access pool so all qualified producers can help scale up production,” Public Citizen says.

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