Lupin has received tentative approval from the U.S. Food and Drug Administration (FDA) to market ivacaftor tablets, a generic version of the cystic fibrosis (CF) therapy Kalydeco. The company’s request came in the form of an abbreviated new drug application (ANDA), containing data submitted for review and approval…
News
A pediatric gastroenterologist in Missouri has been awarded a $50,000 grant to open a study into the potential of an FDA-approved nonsurgical device, called IB-Stim, as a way of easing abdominal pain in children with cystic fibrosis (CF). The grant, by the Institute of…
Treatment with Kalydeco (ivacaftor) led to improved lung function and weight gain as well as fewer respiratory infections and hospitalizations among cystic fibrosis (CF) patients with certain CFTR gating mutations, according to a real-world study. “These results support the long-term effectiveness and use of ivacaftor [Kalydeco] for the…
Instead of stopping Trikafta treatment, reducing the dose and providing psychological support may reduce or resolve mental health side effects, including depression, anxiety, and brain fog in patients with cystic fibrosis (CF), a new study reports. “It was reassuring that dose adjustments, in conjunction with psychological support and…
Treatment with PP-007 — a compound known to promote the release of anti-inflammatory carbon monoxide (CO) gas — significantly reduced the levels of pro-inflammatory immune cells and molecules in the lungs of a mouse model of cystic fibrosis (CF), a study shows. These benefits were associated with an increased production…
Stool consistency and frequency were healthy for the majority of infants with cystic fibrosis (CF) in the first year of life, according to an analysis of data from the BONUS study. Stool consistency and frequency were not associated with pain, while infants exclusively fed with formula or who received…
Researchers at Stanford University have been awarded £210,000 (about $265,000) to study preventing hearing loss caused by a class of antibiotics, called aminoglycosides, that are commonly used to treat lung infections in people with cystic fibrosis (CF). The three-year research project will be jointly funded by the Royal…
A $2.7 million grant from the National Heart, Lung, and Blood Institute, part of the National Institutes of Health (NIH), has been awarded to two stem cell researchers at the University of Houston investigating an alternative cause of chronic lung inflammation in people with cystic fibrosis (CF). The project,…
People from ethnic minority backgrounds were significantly less likely to be eligible for the cystic fibrosis therapy Kaftrio (ivacaftor/tezacaftor/elexacaftor) than white patients, according to a recent U.K. study. Given that the therapy is the most effective CF therapy on the market, “the CF community should urgently address the…
Several potential biomarkers of nontuberculosis mycobacteria (NTM)-associated lung disease were identified in the breath of people with cystic fibrosis (CF) in a recent pilot study. The approach may offer a faster way of reaching an NTM diagnosis, which has historically relied on slow bacterial culture techniques that sometimes delay…
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