News

Raptor’s Cystic Fibrosis Treatment, Inhaled Levofloxacin, Granted FDA Infectious Disease Designation

The U.S. Food and Drug Administration has granted Qualified Infectious Disease Product (QIDP) designation to MP-376, Raptor Pharmaceutical’s inhaled levofloxacin to treat pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis; non-cystic fibrosis bronchiectasis (BE); and nontuberculous mycobacteria (NTM). Raptor, based in Novato, California, is a global biopharma that’s focused on…

CF Foundation Leaders and Advocates Hear Latest on Precision Medicine at White House Summit

Cystic Fibrosis Foundation leaders and cystic fibrosis (CF) community advocates met at the White House with President Barack Obama, officials from the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA), and other CF stakeholders last month for the Precision Medicine Initiative (PMI) Summit. The summit was an opportunity…

Cystic Fibrosis Compound to Stabilize CFTR Protein Advances in Clinical Study

Nivalis Therapeutics, Inc., recently announced an expanded clinical development plan for N91115, the company’s first-in-class stabilizer of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, which is defective in patients with cystic fibrosis (CF). An independent Data Monitoring Committee (DMC) completed a review of interim safety results from the ongoing…

CF Foundation Honors Community Leaders in North Carolina at 6th Annual Standout Awards Banquet

The Cystic Fibrosis Foundation (CF Foundation) honored professionals in the Charlotte, North Carolina, area for their business, community leadership, and philanthropy work at its Sixth Annual STANDOUT Awards banquet, with proceeds from the 2015 event going to further the Foundation’s research, care, and educational programs for cystic fibrosis (CF). A banquet highlight was the…