Biologics

Moderna, FDA Talking to Increase Covid Vaccine Vial Doses

Moderna says it discussing with FDA a proposal to increase Covid-19 vaccine doses in each vial from 10 to 15 doses. The move would help increase the vaccination pace in the U.S. “Implementation of any such changes would be expected to be completed in approximately a two- to three-month period,” a Moderna spokesperson told Politico. The agency reportedly will ask Moderna to submit additional data confirming the change in dosage amount won’t harm vaccine efficacy.

The dose expansion follows President Biden’s decision to purchase an additional 100 million doses of Moderna’s vaccine earlier this week. To date, Moderna has supplied 41 million Covid-19 vaccine doses to the U.S. government. “We appreciate the confidence that the U.S. government has demonstrated in our COVID-19 Vaccine,” Moderna said in a press release. “We continue to scale up our manufacturing capability, both in and outside of the United States. Our goal is to bring our vaccine to as many people as possible around the world to help end this pandemic.”

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