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

Savara Pharma begins phase II study of AeroVanc for MRSA lung infection in CF patients

Savara Pharmaceuticals, an emerging specialty pharmaceutical company, has started study drug treatment in a Phase 2 clinical trial evaluating the safety and efficacy of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis Continue reading Savara Pharma begins phase II study of AeroVanc for MRSA lung infection in CF patients

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

Cystic-fibrosis drug gets first clinical trial

N30 Pharmaceuticals Inc. in Boulder announced Wednesday that it has administered, in a clinical trial, the first dose of a drug designed to treat cystic fibrosis.

The drug, labeled N6022, was administered this week to a patient at National Jewish Health in Denver. Continue reading Cystic-fibrosis drug gets first clinical trial

Stem cell line could also advance research into liver cancers, cystic fibrosis

Published on March 1, 2013 at 12:00 AM
Chronic or acute, liver failure can be deadly. Toxins take over, the skin turns yellow and higher brain function slows.

“There is no effective therapy at the moment to deal with the toxins that build up in your body,” Continue reading Stem cell line could also advance research into liver cancers, cystic fibrosis

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

‘Bloodless’ Lung Transplants Offer Hint at Surgery’s Future

Last April, after being told that only a transplant could save her from a fatal lung condition, Rebecca S. Tomczak began calling some of the top-ranked hospitals in the country.
She started with Emory University Hospital in Atlanta, just hours from her home near Augusta, Ga. Then she tried Duke and the University of Arkansas and Johns Hopkins. Each advised Ms. Continue reading ‘Bloodless’ Lung Transplants Offer Hint at Surgery’s Future