Biologics

Hearing on BioSolutions’ Covid Vaccine Troubles

The House Select Subcommittee on the Coronavirus Crisis will hold a hearing 5/19 that will take testimony from two Emergent BioSolutions top executives on how the company got into FDA trouble over its manufacturing of Covid-19 vaccines at its Baltimore plant. Company president Robert Kramer and executive chairman Fuad El-Hibri are expected to be questioned on findings from an ongoing joint investigation into manufacturing troubles at the plant that was making Janssen’s (Johnson & Johnson) Covid-19 vaccine.

“The hearing will examine how Emergent’s failure to maintain its manufacturing facilities, train its staff, and comply with Food and Drug Administration standards led to the destruction of millions of doses of coronavirus vaccines, including up to 15 million doses of the Johnson & Johnson vaccine, and how these failures may impact vaccination efforts,” a hearing notice says. “It will also explore the Trump Administration’s decision to award Emergent contracts worth hundreds of millions of dollars to manufacture coronavirus vaccines, despite warnings that the company could not be relied upon to quickly and safely manufacture vaccines during a pandemic.” Additionally, the company’s alleged political connections and pricing maneuvers will be examined.

Meanwhile, White House officials told state governors during their weekly call 5/11 that there won't be any doses of Johnson & Johnson's vaccine in next week's federal allocations. The removal of the vaccine from next week’s availability could signal additional regulatory/safety concerns. Officials are not commenting on the vaccine’s current availability or whether availability will resume the following week.

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