Marqibo Clears FDA Despite Advisory Committee Concerns About Confirmatory Trial
This article was originally published in The Pink Sheet Daily
Talon’s liposomal vincristine receives accelerated approval for refractory Ph- acute lymphoblastic leukemia, with a requirement for a confirmatory trial. The firm has a first-line trial under way for that purpose, but it wasn’t well received by the Oncologic Drugs Advisory Committee.
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Spectrum gains an approved drug with the deal and aims for label expansion. Talon’s high-profile investors are counting on an increase in Spectrum share price and post-acquisition milestones to break even.
FDA advisory committee members express concern about the toxicity of Marqibo in the elderly patients expected to enroll in the Phase III confirmatory study for advanced acute lymphoblastic leukemia.
Purell Battling Class Actions Over Disease Claims While World Scrambles To Increase Hand Sanitizer Supplies
Leading chemical firms, beauty and consumer health companies, even distilleries and medical marijuana cultivators are adapting operations to meet global demand for hand sanitizers amid the COVID-19 pandemic. Meanwhile, plaintiff’s attorneys are busy with multiple class actions against Purell manufacturer GOJO Industries for alleged false advertising following a January warning letter to the firm from the US FDA.