KaloBios KB001-A fails Phase 2 study and discontinues development of KB001-A in cystic fibrosis

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced top-line data from the randomized, double-blind, placebo-controlled Phase 2 study of KB001-A, an anti-PcrV monoclonal antibody (mAb) fragment, to treat Pseudomonas aeruginosa (Pa) lung infections in subjects with cystic fibrosis (CF). While the data from this … Continued

NovaBiotics Receives Orphan Drug Status from the FDA for Lynovex for the Treatment of Cystic Fibrosis

NovaBiotics Ltd, the Aberdeen-based clinical-stage biotechnology company, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for Lynovex® (NM001), the Company’s first-in-class  therapeutic candidate for the treatment of Cystic Fibrosis (CF). CF is a … Continued

Parion Sciences Announces $3 Million Award from Cystic Fibrosis Foundation Therapeutics to Accelerate the Development of Novel CF Treatment

Parion Sciences today announced it has received a $3 million award from Cystic Fibrosis Foundation Therapeutics (CFFT) to support the development of P-1037, Parion’s new investigational treatment for cystic fibrosis (CF). This award will accelerate the initiation of a phase … Continued

Vertex Announces Phase 2 Results of Combination Treatment in People with One Copy of the F508del CF Mutation

Vertex Pharmaceuticals Inc. announced results from a Phase 2 clinical trial of the cystic fibrosis drug ivacaftor (Kalydeco™) in combination with another potential therapy, lumacaftor, in people with one copy of the F508del mutation, ages 18 and older. In the … Continued

Proof-of-Concept Study of Ivacaftor Monotherapy Showed Improvements in Lung Function After Two Weeks of Treatment in People with Cystic Fibrosis who have a Residual Function Mutation

Data are consistent with in vitro observations in residual function mutations showing that ivacaftor improved CFTR activity 8-week open-label period showed improvements in lung function Data support plans to initiate a Phase 3 study of ivacaftor in people with CF … Continued

Insmed Announces Positive Open Label Data from Phase 2 Clinical Trial of ARIKAYCE for Treatment Resistant Nontuberculous Mycobacterial Lung Infections

Poster Presentation at the American Thoracic Society Annual Meeting 2014 Reports Twenty-One Culture Negative Patients at Day 168 of Study Insmed Incorporated today announced additional results from the Company’s phase 2 clinical trial of ARIKAYCETM, or liposomal amikacin for inhalation, for the … Continued

Insmed Announces Results from Phase 2 Clinical Trial for Treatment Resistant Nontuberculous Mycobacterial Lung Infections

Insmed Incorporated today reported results from the Company’s phase 2 clinical trial of ARIKAYCETM, or liposomal amikacin for inhalation, for the treatment of patients with treatment resistant nontuberculous mycobacterial (NTM) lung infections. The randomized, double-blind, placebo-controlled phase 2 clinical trial … Continued