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FDA Approves Kalydeco for Treatment of Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO …

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FDA Grants Orphan Drug Designation to Onspira’s Investigational Bronchiolitis Obliterans Therapy

WAYNE, Pa.–(BUSINESS WIRE)–Onspira Therapeutics, a privately-held clinical-stage biopharmaceutical company dedicated to developing therapies to treat rare, life threatening pulmonary diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational product, OSP-101, for the treatment of Bronchiolitis Obliterans (BO). BO is a progressive …

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FDA Approves Vertex’s Orkambi to Treat Cystic Fibrosis Patients Ages 2-5 Years with Most Common Form of Disease

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved ORKAMBI® (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF …

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FDA Grants Orphan Drug Designation to Pliant’s Investigational Idiopathic Pulmonary Fibrosis Therapy

SOUTH SAN FRANCISCO, Calif., Aug. 6, 2018 /PRNewswire/ — Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s anti-fibrotic lead compound, PLN-74809, for the treatment …

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Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium, Imperial Innovations and Oxford Biomedica Partner to Develop Gene Therapy for Cystic Fibrosis

INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium (GTC)—consisting of Imperial College London and the Universities of Oxford and Edinburgh—Imperial Innovations, and Oxford BioMedica (OXB) announce a global collaboration to develop a first-in-class, long-term therapy for patients with cystic fibrosis (CF). The new partnership brings together the …

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Celtaxsys’ Cystic Fibrosis Drug Demonstrated Clinically Meaningful Improvements in Pulmonary Exacerbations in Phase 2 Trial

ATLANTA, Aug. 02, 2018 (GLOBE NEWSWIRE) — Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, today announced top line results of its Phase 2 EMPIRE-CF trial evaluating oral, once daily anti-inflammatory molecule, acebilustat, for the treatment of cystic fibrosis (CF), …

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Galapagos Announces Topline Results from Cystic Fibrosis Study and Says AbbVie will not Proceed with Second CF Combo

Mechelen, Belgium; 28 June 2018; 22.35 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces the topline results with investigational C2 corrector GLPG2737 in the first Phase 2 CF patient trial with this candidate and provides an update on its triple combo development strategy. The PELICAN study was designed …

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AstraZeneca’s Fasenra Fails in Late-Stage Chronic Obstructive Pulmonary Disease Trial

AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with …

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Vertex Initiates Late-Stage Studies for its Triple Combination Regimen for Patients with Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it is initiating two Phase 3 studies of VX-445, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF). The first Phase 3 study will evaluate approximately 360 people with CF who have one copy of the F508del mutation …

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Theravance Biopharma’s Trelegy Ellipta Significantly Benefits COPD Patients in Landmark IMPACT Study

DUBLIN, April 19, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today highlighted the publication in the New England Journal of Medicine (NEJM) of the landmark IMPACT study of Trelegy Ellipta in patients with chronic obstructive pulmonary disease (COPD). The IMPACT study is one of the largest trials …

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