Lung Surfactants/Mucolytics

Is Azithromycin Beneficial Post-Hematopoietic Stem Cell Transplant?

August 09, 2017

The researchers found that the 2-year airflow decline-free survival was 32.8 and 41.3% with azithromycin and placebo, respectively (unadjusted hazard ratio, 1.3).

Combo Tx Significantly Improves Lung Function in Cystic Fibrosis Study

By April 11, 2017

Results showed that the ivacaftor/tezacaftor group reached the primary endpoint with a mean absolute improvement in ppFEV1 of 4% points from baseline vs. placebo (P<0.0001).

New Antibiotic Tx Assessed in Cystic Fibrosis Post Lung Function Decline

April 05, 2017

The researchers found that new antibiotic treatment was associated with an increased likelihood of recovery to 90% of baseline (P<0.001), especially for hospitalization compared to no new antibiotic.

Telehealth Presents New Utilization Opportunities But at What Cost?

March 23, 2017

Eighty-eight percent of telehealth visits for ARI were new utilization; increase in net spending per user.

Independent Survival Indicator ID'd for Idiopathic Pulmonary Fibrosis

November 28, 2016

For patients with idiopathic pulmonary fibrosis (IPF), fat-free mass index (FFMI) predicts survival, according to a study published online in Respirology.

Aerosurf Fast Tracked for RDS in Premature Infants

By September 20, 2016

The FDA has granted Fast Track designation to Aerosurf (lucinactant for inhalation; Windtree Therapeutics) for the treatment of respiratory distress syndrome (RDS) in premature infants.

Surfactant Admin at 36 weeks and 1 year Examined in Trial

March 01, 2016

Late administration of surfactant does not reduce the duration of ventilation in very preterm neonates with prolonged respiratory distress, according to research published online February 29 in JAMA Pediatrics.

Study Examines Interstitial Lung Abnormalities Affect on Mortality

February 17, 2016

Interstitial lung abnormalities correlate with increased risk of all-cause mortality, according to research published in the Journal of the American Medical Association.

Emphysema Patients Benefit From Lung Volume Reduction Tx

January 13, 2016

Lung volume reduction coil treatment may help improve the ability to exercise for patients with severe emphysema, according to a study published in the January 12 issue of the Journal of the American Medical Association.

Excess Relative Risk of Repeat CT Scans Can Be Quantified

December 04, 2015

Recent publication demonstrates that very low doses repeated over time as harmful as acute exposure

Gene Therapy Found to Improve Lung Function in CF

By July 02, 2015

Gene therapy showed a significant benefit in lung function in patients with cystic fibrosis, data from a Phase 2 trial has shown.

Expanded Age Range for Kalydeco Now Approved

By March 18, 2015

Vertex Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved Kalydeco (ivacaftor) for use in children ages 2-5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Pulmozyme with eRapid Nebulizer Use Approved for CF

By January 27, 2015

The Food and Drug Administration (FDA) has approved PARI's eRapid Nebulizer System (eRapid), the first electronic nebulizer to deliver Pulmozyme (dornase alfa [recombinant human DNase]; Genentech) for the treatment of cystic fibrosis.

Lumacaftor + Ivacaftor NDA Submitted for Cystic Fibrosis

November 05, 2014

Vertex announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for the combination product lumacaftor and ivacaftor for people with cystic fibrosis (CF) ages ≥12 who have two copies of the F508del mutation in the cystic fibrosis transmembrance conductance regulator (CFTR) gene.

Intranasal Flu Vaccine Use in Cystic Fibrosis Patients: Assessing the Risks

October 01, 2014

Children with cystic fibrosis (CF) have an increased risk of morbidity and higher case fatality during the influenza pandemic compared to patients with other chronic respiratory diseases or healthy controls.

Lynovex Designated Orphan Drug for Cystic Fibrosis

September 16, 2014

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Lynovex (NM001; NovaBiotics) for the treatment of cystic fibrosis (CF).

U.S. Children With Cystic Fibrosis Are Living Longer

August 19, 2014

In the United States, children born in 2010 with cystic fibrosis (CF) are projected to live longer than those born earlier.

Fresenius Kabi Launches Acetylcysteine 10% Solution

August 18, 2014

Fresenius Kabi announced the launch of Acetylcysteine Solution, 10%.

Combo Cystic Fibrosis Therapy Promising in Trials

June 24, 2014

Vertex announced results from two Phase 3 studies of lumacaftor in combination with ivacaftor in patients with cystic fibrosis (CF) who have two copies of F508del mutation in the CFTR gene.

Acetylcysteine Solution 4mL Vials Now Available

February 24, 2014

Fresenius Kabi USA announced its launch of Acetylcysteine Solution 20% in 4mL vials for inhalation or oral administration.

Kalydeco Gains Expanded Cystic Fibrosis Indication

February 21, 2014

The FDA has approved a sNDA for Kalydeco (ivacaftor; Vertex) for use in patients with cystic fibrosis (CF) ages >6 years old who have 1 of 8 additional mutations in the CF transmembrane conductance regulator (CFTR) gene.

Glass Particles Found in Acetylcysteine Solution

February 18, 2014

Ben Venue Laboratories announced a nationwide recall of Roxane's Acetylcysteine Solution 10%.

Acetylcysteine Solution 20% Launched in 10mL Vials

December 16, 2013

Fresenius Kabi USA has announced the launch of Acetylcysteine Solution 20% in a 10mL vial for inhalation or oral administration.

New Guidelines Target Mucus Clearance in Hospitalized Patients

November 19, 2013

There is currently a lack of evidence showing the benefit of certain therapies to clear mucus in the lungs when performed routinely in hospitals, according to the American Association for Respiratory Care (AARC).

Surfaxin Launched for RDS Prevention

November 08, 2013

Discovery Laboratories announced its launch of Surfaxin (lucinactant) Intratracheal Suspension for the prevention of respiratory distress syndrome (RDS) in premature infants at high-risk for RDS.

Update on Surfaxin Availability for RDS

October 04, 2013

The FDA has approved updated product specifications for Surfaxin (lucinactant; Discovery Laboratories), allowing Discovery Laboratories to initiate manufacturing for its planned commercial introduction in the fourth quarter of 2013.

Vertex Submits sNDA to Expand Kalydeco Indication

September 30, 2013

Vertex has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Kalydeco (ivacaftor) monotherapy for people with cystic fibrosis (CF) ages 6 and older who have at least one non-G551D gating mutation in the CFTR gene.

Recall: Six Drug Products from JCB Labs

August 28, 2013

JCB Laboratories has issued a recall of six lots of sterile drug products after a recent FDA inspection due to concern regarding unreliable and inaccurate sterility assurance tests.

Positive Phase 3 Results for Kalydeco Label-Expansion in Cystic Fibrosis

July 30, 2013

Vertex announced results from an ongoing Phase 3 label-expansion study of Kalydeco (ivacaftor) monotherapy in patients with cystic fibrosis (CF) who have a non-G551D gating mutation.

On-Demand Inhalation Effective in Bronchiolitis

June 13, 2013

In infants with acute bronchiolitis, on-demand inhalation of either adrenaline or saline are effective in shortening hospital stays and reducing the need for supportive treatment, compared with fixed-schedule inhalation.