cystic fibrosis

Santhera to Develop, Market Polyphor Experimental CF Therapy

Santhera Pharmaceuticals has bought the rights to POL6014, a medication being developed by Polyphor to treat cystic fibrosis (CF) and other pulmonary diseases. Under terms of the global licensing agreement between the two Swiss companies, Santhera will develop, handle regulatory filings and market the investigative drug and derivate…

Arch Biopartners Enrolling Volunteers in Phase 1 Trial of AB569, Therapy Candidate for Drug-resistant Bacterial Lung Infections

A Phase 1 clinical trial testing Arch Biopartners’ AB569 for the treatment of antibiotic-resistant bacterial infections is now enrolling healthy volunteers. The therapy candidate could be a new help for patients with cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), and other respiratory conditions. The trial will evaluate the…

FDA Approves Symdeko, Vertex’s Combo Therapy for Patients with Certain Mutations in CFTR Gene

Vertex Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Symdeko (tezacaftor/ivacaftor and ivacaftor) as a therapy for cystic fibrosis (CF) patients carrying two copies of the F508del mutation in the CFTR gene (the gene defective in CF) or with one mutation that responds to tezacaftor/ivacaftor. The therapy was approved for…

2 CF Case Reports Show Successful Use of GM-CSF for Treating Nontuberculous Mycobacteria

Savara Pharmaceuticals announced the publication of two case reports demonstrating that inhaled granulocyte-macrophage colony stimulating factor (GM-CSF) either eradicated or dramatically reduced Mycobacterium abscessus (M. abscessus) infection, improved clinical outcomes, and was well-tolerated in patients with cystic fibrosis (CF). The results were published in the European Respiratory Journal in an…

Potential Therapy for CF Patients with Hearing Loss Due to Antibiotics OK’d for Clinical Trial

The U.S. Food and Drug Administration (FDA) gave a green light to human testing of ORC-13661,  Oricula Therapeutics‘ treatment candidate to prevent hearing loss in people taking high doses of aminoglycoside antibiotics, including patients with cystic fibrosis. Approval given the company’s Investigational New Drug Application will enable Oricula to test…