Biologics

Slaoui Resigns from Warp Speed at Biden Team Request: Report

Operation Warp Speed chief adviser Moncef Slaoui has resigned at the request of the Biden administration, CNBC reports. The cable business network says the controversial former GlaxoSmithKline executive will remain in his role for a month to assist in the transition.

Sources tell CNBC that Slaoui’s role in leading vaccine development will be diminished after 1/20 and will end by 2/12. There’s no indication whether someone will be appointed to take his role as scientific lead for vaccine development. Biden has already named a Covid-19 vaccine coordinator, who is focused on vaccine delivery, and a Covid-19 response coordinator.

Slaoui was criticized when he took the job due to his ties to the pharmaceutical industry and refusal to sell his Glaxo shares, claiming they were his retirement after working there for 30 years in vaccine development. He resigned from the Moderna board about the time of his appointment and sold his Moderna shares. He was paid $1,000 for his work overseeing Operation Warp Speed and said he would donate the money to scientific research.

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

Read more

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