Prone positioning and oscillation fail in pediatric ARDS trial; Werfen recalls HIT assay lots; FDA approves plasmid DNA immunotherapy for RRP
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read by AI voices · all episodesNeither prone positioning nor high-frequency oscillatory ventilation added ventilator-free days in the PROSpect trial of 424 young patients with acute respiratory distress syndrome, published in The Lancet.
Werfen is recalling four lots of its HemosIL AcuStar HIT-IgG(PF4-H) assay because negative bias can produce false-negative heparin-induced thrombocytopenia results, the Food and Drug Administration (FDA) said. The FDA also granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy, for recurrent respiratory papillomatosis. A Veterans Affairs lifestyle program did not significantly improve weight loss in patients with sleep apnea.
- Research Oct 31, 2026The phase 3 PROSpect trial, in The Lancet's Oct. 31 issue, randomized 424 of 600 planned patients aged 2 weeks to 20 years with early moderate-to-severe acute respiratory distress syndrome at 75 pediatric intensive care units in 18 countries before stopping for futility and slow enrollment. Ventilator-free days through day 28, the primary end point, did not differ significantly: 17.3 with high-frequency oscillatory ventilation (HFOV) versus 18.0 with conventional ventilation, and a median 17.9 prone versus 17.4 supine. Hemodynamic instability affected 13% with HFOV versus 9% with conventional ventilation. The authors said routine use of either strategy is not recommended.Sources: The Lancet, PubMed
- FDA Oct 30, 2026The Food and Drug Administration (FDA) posted Oct. 30 a recall of four lots of the HemosIL AcuStar HIT-IgG(PF4-H) immunoassay from Instrumentation Laboratories (Werfen), which confirmed a 20% to 35% negative bias that may not be caught by routine calibration and quality control. Results can fall below the 1.00 U/mL cutoff, so a patient with heparin-induced thrombocytopenia could test negative and keep receiving heparin, raising thrombotic risk. Werfen reported no serious injuries or deaths and expects a supply interruption; laboratories are told to destroy affected lots and find an alternative test.Source: FDA
- FDA Oct 30, 2026The Food and Drug Administration (FDA) on Oct. 30 granted accelerated approval to Inovio Pharmaceuticals' Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis, in which growths caused by HPV types 6 and 11 form in the airways, most often around the larynx. In an open-label multicenter trial of 32 adults, seven of 26 patients with at least three baseline surgeries (27%) needed no surgery in the first year after treatment. Common adverse reactions included injection site reactions, headache, fatigue and hypertension.
- Research Oct 30, 2026The pragmatic POWER trial, published Oct. 30 in the American Journal of Respiratory and Critical Care Medicine, randomized 696 patients with obstructive sleep apnea and obesity at Veterans Affairs sites to a self-directed program based on the Diabetes Prevention Program or usual care. At 12 months, unadjusted weight fell 2.1 kg versus 0.9 kg (adjusted difference -1.1 kg, 95% CI -2.0 to -0.1; P = .037), short of the P = .025 threshold set for two co-primary outcomes. The sleep quality-of-life score improved 0.6 points more (P = .001), a gain the authors said was of limited clinical importance.Sources: Am J Respir Crit Care Med, PubMed
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