Drugs

FDA Lifts 1 Emavusertib Clinical Hold

FDA has lifted its partial clinical hold on the TakeAim Lymphoma Phase 1/2 study of emavusertib after reviewing data submitted by Curis. Company officials say they are working with clinical sites to resume patient enrollment. Curis says the partial clinical hold was lifted following an agreement with the agency on the company’s strategy for rhabdomyolysis identification and management and on the enrollment of at least nine additional patients at the 200 mg dose level of emavusertib in combination with ibrutinib.

Emavusertib is described as an IRAK4 kinase inhibitor. Curis says IRAK4 plays an essential role in the toll-like receptor and interleukin-1 receptor signaling pathways, which are frequently dysregulated in patients with cancer.

A partial clinical hold remains in effect for the company’s TakeAim Leukemia study.

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