Respinova’s non-invasive Pulsehaler, a medical device meant to ease breathing in patients with airway restrictions, such as in cystic fibrosis (CF), has been cleared for marketing in the U.S. Pulsehaler was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) following the company’s submission of a…
News
A Phase 2 clinical trial assessing the safety and efficacy of BX004 — BiomX’s phage therapy candidate for Pseudomonas aeruginosa infections in people with cystic fibrosis (CF) — remains on track to have results by the end of this year, the company announced. While this timeline had been…
A clinical trial underway in Israel is investigating how well a personalized chest physiotherapy system compares with traditional airway clearance techniques in people with cystic fibrosis (CF) and other chronic lung conditions, a company reports. “This trial brings us one step closer to our goal: improving the lives of millions…
Treatment with MS1819 for exocrine pancreatic insufficiency (EPI) — when the pancreas does not release enough digestive enzymes and the body doesn’t receive proper nutrition — was found to be safe and well-tolerated among cystic fibrosis (CF) patients in the OPTION 2 trial, top-line results show. However, MS1819 was…
Olgram has raised €1.5 million (about $1.77 million) in seed funding from investors to speed its development of antibiotics to clear persistent bacteria responsible for chronic, repeat infections. The company’s immediate focus is cystic fibrosis (CF), a disease characterized by chronic bacterial infection in the lungs. In a…
Eloxx Pharmaceuticals has acquired Zikani Therapeutics and will expand its research program in ribosomal RNA-targeted therapies, with the goal of treating diseases such as cystic fibrosis (CF) caused by a specific type of genetic mutation. …
Disease progression and the overall health of young people with cystic fibrosis (CF) can be evaluated by putting them through the modified shuttle test (MST) once, as its repeated use showed no significant differences in exercise capacity, a study reports. This test involves repeated movement along…
Thirona announced it has developed a new software program that can quickly detect and quantify lung anomalies in cystic fibrosis (CF) patients, including those beyond the capacity of a doctor in a clinic. The software is based on an artificial intelligence (AI) algorithm, called PRAGMA-AI, that is reported…
The Cystic Fibrosis Foundation (CFF) is awarding Life Edit Therapeutics up to $400,000 to explore its new gene-editing technology to develop treatments for certain patients with cystic fibrosis (CF) who cannot benefit from existing medicines. “We’re looking forward to working with the CF Foundation to leverage the unique…
A European Medicines Agency (EMA) committee favors extending the label for Kaftrio (ivacaftor/tezacaftor/elexacaftor), in combination with Kalydeco (ivacaftor), to treat cystic fibrosis (CF) patients 12 and older who have at least one copy of the CFTR gene with an F508del mutation. The European Commission (EC) approved the same combination last year…
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