Cystic Fibrosis News and Research

Latest Cystic Fibrosis News and Research

Discovery Labs reports net operating loss of $6.2 million for third quarter 2010

Discovery Laboratories, Inc., a biotechnology company developing its novel, synthetic, peptide-containing surfactant and related aerosolization technologies as first in class therapies for severe respiratory diseases, today provides an update on key pipeline and business initiatives and a financial update for the third quarter ended September 30, 2010.

9 Nov 2010

Synergy receives $244,479 grant under QTDP program to develop plecanatide for gastrointestinal disorders

Synergy Pharmaceuticals, Inc. a developer of new drugs to treat gastrointestinal disorders (GI) and diseases, announced today that it has been awarded a $244,479 grant under the Qualifying Therapeutic Discovery Project (QTDP) program to aid the Company in its development of plecanatide currently in clinical development to treat gastrointestinal disorders.

8 Nov 2010

Inspire third quarter net loss decreases to $7.6 million

Inspire Pharmaceuticals, Inc. announced today financial results for the third quarter ended September 30, 2010, reporting a net loss of $7.6 million or ($0.09) per share, an improvement from the third quarter of 2009 during which the Company incurred a net loss of $8.5 million or ($0.12) per share.

4 Nov 2010

DARA awarded $0.5M grant under Patient Protection and Affordable Care Act for advancing KRN5500 and DB959

DARA BioSciences announced today grant approvals by the Internal Revenue Service under the Patient Protection and Affordable Care Act of 2010 for KRN5500 and DB959 in the amount of approximately $500,000 for the calendar year 2009.

3 Nov 2010

FDA grants orphan drug designation to Discovery's KL4 surfactant for CF treatment

Discovery Laboratories, Inc. today announced that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to Discovery's KL4 surfactant for the treatment of cystic fibrosis (CF).

1 Nov 2010

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Vertex Pharmaceuticals Incorporated today announced new data from its Phase 3 studies of people with genotype 1 chronic hepatitis C who have not been treated previously. In these studies, the majority of people achieved superior sustained viral response (SVR or viral cure) rates with a telaprevir-based combination regimen, compared to current therapies, regardless of race/ethnicity or stage of liver fibrosis (factors known to limit response to current hepatitis C treatments).

1 Nov 2010

Nanomedicine Center for Nucleoprotein Machines receives $16.1 million NIH award

The Georgia Tech-led Nanomedicine Center for Nucleoprotein Machines has received an award of $16.1 million for five years as part of its renewal by the National Institutes of Health (NIH). The eight-institution research team plans to pursue development of a clinically viable gene correction technology for single-gene disorders and demonstrate the technology's efficacy with sickle cell disease.

29 Oct 2010

New iPSC cell lines could help in treating patients with lung diseases

A team of researchers from Boston University's Center for Regenerative Medicine and the Pulmonary Center have generated 100 new lines of human induced pluripotent stem cells (iPSC) from individuals with lung diseases, including cystic fibrosis and emphysema. The new stem cell lines could possibly lead to new treatments for these debilitating diseases.

29 Oct 2010

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 Oct 2010

DARA BioSciences to raise $1.4 million in registered direct offering

DARA BioSciences, Inc., a development-stage pharmaceutical company, today announced that it has entered into a definitive agreement with several institutional investors to sell 612,667 units, with each unit consisting of one of the Company's common shares and 0.50 warrants to purchase one share of common stock, for gross proceeds of approximately $1.4 million, before deducting placement agent fees and estimated offering expenses, in a "registered direct" offering.

25 Oct 2010

Pharmaxis announces combined results of Bronchitol Phase III trial for cystic fibrosis

Pharmaceutical company Pharmaxis today announced significant results of pooled data from its two large scale six month Phase III trials of Bronchitol (inhaled mannitol) in people with cystic fibrosis.

25 Oct 2010

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Inspire Pharmaceuticals, Inc. announced today that data will be presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the 24th Annual North American Cystic Fibrosis Conference (NACFC) October 21-23, 2010 in Baltimore, Maryland.

22 Oct 2010

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved its co-primary endpoint of superiority of Cayston for mean actual change in forced expiratory volume in one second (FEV1, a measure of lung function) percent predicted across three treatment cycles (six months).

22 Oct 2010

TOBI reduces mortality in patients with cystic fibrosis, Pa lung infection

A new analysis of data from more than 12,000 people with cystic fibrosis (CF) and Pseudomonas aeruginosa (Pa) lung infection in the Cystic Fibrosis Foundation's Patient Registry shows that use of TOBI (Tobramycin Inhalation Solution, USP) was associated with a 21% reduction in mortality in the following year.

22 Oct 2010

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

Aradigm Corporation today announced positive top line data from its recently concluded 6-month Phase 2b study (ORBIT-2) with Aradigm's once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis.

20 Oct 2010

Gilead Sciences third quarter total revenues increase 8% to $1.94 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended September 30, 2010. Total revenues for the third quarter of 2010 were $1.94 billion, up 8 percent compared to total revenues of $1.80 billion for the third quarter of 2009. Net income for the third quarter of 2010 was $704.9 million, or $0.83 per diluted share, compared to net income for the third quarter of 2009 of $673.0 million, or $0.72 per diluted share.

20 Oct 2010

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 2a clinical trial that will evaluate multiple combinations of VX-770 and VX-809, investigational oral cystic fibrosis transmembrane conductance regulator (CFTR) modulators for the treatment of cystic fibrosis (CF). The trial is designed to evaluate the safety and tolerability of VX-809 dosed alone for 14 days followed by dosing of VX-809 in combination with VX-770 for 7 days.

18 Oct 2010

Metabolon announces publication of metabolic analysis of biochemical changes in CF primary lung epithelial cells

Metabolon, Inc., the leader in global metabolomics, biomarker discovery and analysis, announces the publication of "Metabolomic Profiling Reveals Biochemical Pathways and Biomarkers Associated with Pathogenesis in Cystic Fibrosis Cells", in the Journal of Biological Chemistry.

18 Oct 2010

PTC announces ataluren Phase 2b efficacy data at International Congress

PTC Therapeutics, Inc. today announced that final analyses of Phase 2b efficacy data suggest the investigational new drug ataluren slowed the loss of walking ability in patients with nonsense mutation dystrophinopathy, a disease continuum comprising Duchenne and Becker muscular dystrophy (nmDBMD). These data were presented at the International Congress of the World Muscle Society in Kumamoto, Japan and will be the basis of interactions with the U.S. Food and Drug Administration (FDA) and national regulatory authorities in Europe in the fourth quarter of 2010.

18 Oct 2010

Discovery Labs to present lucinactant Phase 2a clinical study results at NACFC Conference

Discovery Laboratories, Inc. today announces that the Phase 2a clinical study of aerosolized KL4 surfactant (lucinactant) in patients with cystic fibrosis (CF) has completed and the results from the study will be presented at the upcoming North American Cystic Fibrosis Conference (NACFC; October 21-23, 2010).

15 Oct 2010

Cystic Fibrosis News and Research

Latest Cystic Fibrosis News and Research

Discovery Labs reports net operating loss of $6.2 million for third quarter 2010

Synergy receives $244,479 grant under QTDP program to develop plecanatide for gastrointestinal disorders

Inspire third quarter net loss decreases to $7.6 million

DARA awarded $0.5M grant under Patient Protection and Affordable Care Act for advancing KRN5500 and DB959

FDA grants orphan drug designation to Discovery's KL4 surfactant for CF treatment

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Nanomedicine Center for Nucleoprotein Machines receives $16.1 million NIH award

New iPSC cell lines could help in treating patients with lung diseases

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

DARA BioSciences to raise $1.4 million in registered direct offering

Pharmaxis announces combined results of Bronchitol Phase III trial for cystic fibrosis

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

TOBI reduces mortality in patients with cystic fibrosis, Pa lung infection

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

Gilead Sciences third quarter total revenues increase 8% to $1.94 billion

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Metabolon announces publication of metabolic analysis of biochemical changes in CF primary lung epithelial cells

PTC announces ataluren Phase 2b efficacy data at International Congress

Discovery Labs to present lucinactant Phase 2a clinical study results at NACFC Conference

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Cystic Fibrosis News and Research

Latest Cystic Fibrosis News and Research

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