News

CF Children with Rhinovirus Infections Less Likely to Recover Lung Function after Flares

Rhinovirus infections in children with cystic fibrosis (CF) are linked to a lack of improvement in lung function after treatment for pulmonary exacerbations caused by the infection, a recent study reported. The study,“Rhinovirus-associated pulmonary exacerbations show a lack of FEV1 improvement in children with cystic fibrosis,“ analyzed 18 children who were…

CF Infection Can Be Safely Treated by Daily and Continuous Tobi Use, Study Reports

A study comparing two continuous treatment regimens of tobramycin inhalation (Tobi) for Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) found that administration of both once a day and twice daily treatment was safe and well-tolerated. The study, titled “Pharmacokinetics and safety of an 8 week continuous treatment with once-daily versus twice-daily inhalation…

Mild Cystic Fibrosis in Pediatric Patient Found to Be Caused by Rare Gene Mutation

Researchers identified a novel, rare mutation causing cystic fibrosis (CF) in a pediatric African-American patient. The mutation, however, was found to be responsive to the CFTR corrector VX-809, therefore identifying potential personalized therapeutics. The study, “c.3623G > A mutation encodes a CFTR protein with impaired channel function,” was published…

Kalydeco Fails to Gain FDA Approval as CF Treatment for Specific Residual Mutations

Vertex Pharmaceuticals Incorporated recently announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) to its supplemental New Drug Application (sNDA) for Kalydeco (ivacaftor) as a treatment for cystic fibrosis patients ages 2 and older with one of 23 residual function mutations in the cystic fibrosis transmembrane conductance…

Potential CF Treatment for Antibiotic-Resistant Infections Seeks EU Orphan Drug Designation

Arch Biopartners, Inc, announced that it recently submitted an orphan drug designation application to the European Medicines Authority (EMA) for its product AB569, a potential treatment of pulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis (CF). The EMA is now reviewing the application, and the Committee for Orphan Medicinal Products…