Biologics

Dissident FDA Vaccines Deputy Joins Adjuvance Technologies

Former CBER Office of Vaccines Research and Review (OVRR) deputy director Philip Krause has joined Adjuvance Technologies as a strategic consultant. The privately-held clinical-stage biopharmaceutical company says it is focused on developing next-generation saponin adjuvants and vaccines for infectious disease and immuno-oncology. Saponin adjuvants are described as potent immune stimulators and important components of licensed, currently marketed, and clinically advanced infectious disease vaccines. “The usefulness of saponin adjuvants has been constrained by dose-limiting tolerability and manufacturing challenges,” the company says.

Krause and OVRR director Marion Gruber retired last year in protest over how the agency and Biden Administration are handling Covid-19 vaccine reviews and approvals. In September, Krause and Gruber joined outside researchers to argue against requiring Covid-19 booster shots until data can show a necessary benefit. Writing in a 9/13 Lancet viewpoint article, the then-FDAers and researchers say current evidence did not show a need for boosters for the general population because efficacy against severe disease remains high. The two former officials also reportedly had been frustrated by CDC and its Advisory Committee on Immunization Practices for making decisions on issues that should be reserved for FDA, and by a lack of support from CBER director Peter Marks.

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