Drugs

X4 Pharma Fast Track Status for Mavorixafor

FDA has granted X4 Pharmaceuticals a Fast Track Designation for mavorixafor for treating adult patients with WHIM (Warts, Hypogammaglobulinemia Infections and Myelokathexis) syndrome, an inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The company describes mavorixafor as a small molecule antagonist of chemokine receptor CXCR4, currently being investigated in a Phase 3 clinical trial, 4WHIM. The study is expected to enroll up to 28 subjects in about 20 countries, followed by an open-label extension trial, with results expected in 2022. “We recently showed the potential therapeutic benefit of mavorixafor in a Phase 2 clinical trial in WHIM, with significant increases in white blood cell counts and reductions in infection rates and wart burden,” it says.

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