News

UK Patients Urged to Stop Using Aquilon’s Medical Nebulizers

The U.K.’s Medicines & Healthcare products Regulatory Agency (MHRA) issued an alert to urge patients and healthcare professionals to stop using Aquilon‘s medical nebulizers. Among those affected are patients with cystic fibrosis and asthma. All medical devices marketed in Europe need to have a mandatory CE certification,…

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…