Extended-Infusion Cefepime Reduces Mortality in Patients with Pseudomonas aeruginosa Infections; Bauer KA, West JE, O’Brien JM, Goff DA; Antimicrobial Agents & Chemotherapy (Apr 2013)

In an era of escalating resistance and lack of new antimicrobial discovery, stewardship programs must utilize knowledge of pharmacodynamics to achieve maximal exposure in the treatment of Pseudomonas aeruginosa infections. We evaluated the clinical and Continue reading Extended-Infusion Cefepime Reduces Mortality in Patients with Pseudomonas aeruginosa Infections; Bauer KA, West JE, O’Brien JM, Goff DA; Antimicrobial Agents & Chemotherapy (Apr 2013)

For new Rhode Island firm, peptides hold hope for disease-altering cystic fibrosis treatments

It’s been nearly two and a half decades since the gene associated with the inherited disease cystic fibrosis was discovered, paving the way for disease-modifying drugs. In that time, only one such drug has been approved in the U.S. and Europe – Vertex’s Kalydeco. And that drug is only Continue reading For new Rhode Island firm, peptides hold hope for disease-altering cystic fibrosis treatments

U.S. FDA Grants Fast-Track Designation to Sanofi Pasteur and KaloBios’ Novel Biologic Candidate for Pseudomonas aeruginosa

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), and KaloBios Pharmaceuticals (KBIO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sanofi Pasteur for the investigation of KB001A, an Continue reading U.S. FDA Grants Fast-Track Designation to Sanofi Pasteur and KaloBios’ Novel Biologic Candidate for Pseudomonas aeruginosa

N30 Pharma Announces Presentation of Preclinical Data at the Basic Science Meeting of the European Cystic Fibrosis Society

N30 Pharmaceuticals, Inc., a clinical stage, biopharmaceutical company focused on the development of therapies for cystic fibrosis (CF), announced today the presentation of key preclinical data for its novel inhibitors of S-nitrosoglutathione reductase (GSNORi). The data were Continue reading N30 Pharma Announces Presentation of Preclinical Data at the Basic Science Meeting of the European Cystic Fibrosis Society

U.S. FDA OKs Novartis inhaler to treat lung infection in cystic fibrosis patients

U.S. health regulators approved on Friday a hand-held inhaler made by Swiss drug maker Novartis AG to treat a type of bacterial lung infection that often affects cystic fibrosis patients.
Novartis’s TOBI Podhaler contains a dry powder formulation of tobramycin, an antibiotic used to Continue reading U.S. FDA OKs Novartis inhaler to treat lung infection in cystic fibrosis patients

FDA Sends Cystic Fibrosis Treatment Back for More Study

Mar 19, 2013 – The US Food and Drug Administration (FDA) has completed its review of Pharmaxis’ New Drug Application (NDA) for its dry powder formulation of mannitol (Bronchitol, Pharmaxis) and has recommended that the company conduct an additional study to obtain Continue reading FDA Sends Cystic Fibrosis Treatment Back for More Study

Vertex Readies Late-Stage Cystic Fibrosis Drug Studies

Vertex Pharmaceuticals (VRTX) announced Tuesday night the design of two phase III studies for its combination therapy to treat the most common form of cystic fibrosis. The studies will each run for six months, so results could be ready as early as the end of 2013 or during first half of 2014.

If the studies are positive, Vertex intends to file for U.S. approval in 2014. Continue reading Vertex Readies Late-Stage Cystic Fibrosis Drug Studies

Pharma And Biotech

Promising pre-clinical data in Cystic Fibrosis for ProtAffin AGs PA401 to be presented at ATS, Philadelphia, 17-22 May 2013

ProtAffin AG, a biotechnology company developing a novel class of next-generation biopharmaceuticals for inflammation, respiratory disease and oncology, has announced that a collaboration with a leading European centre for the study of cystic fibrosis has generated Continue reading Pharma And Biotech

Saving Money with Patient Assistance Programs

Many manufacturers of medications used by CF patients offer patient assistance programs to assist individuals with insufficient or no insurance coverage to obtain medications. Programs vary in their offerings from sampling products, providing nutritional supplements, and co-pay assistance.

Digestive Enzymes Continue reading Saving Money with Patient Assistance Programs