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FDA Grants Orphan Drug Designation to Synspira’s Investigational Cystic Fibrosis Therapy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Synspira, a privately held company developing a new class of inhaled glycopolymer-based therapeutics for the treatment of pulmonary disease, today announced that it has been granted Orphan Designation by the United States Food and Drug Administration (FDA) for poly (acetyl, arginyl) glucosamine (PAAG15A), for the treatment of cystic …

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FDA Approves Stiolto Respimat sNDA to Add on COPD Exacerbation Reduction

RIDGEFIELD, Conn., Oct. 11, 2018 /PRNewswire/ — Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) approved new labeling for Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium, which is the active ingredient in …

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Arena Announces Positive Long-Term Data from its Phase 2 Trial for Ralinepag in Pulmonary Arterial Hypertension

SAN DIEGO, Oct. 2, 2018 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive data from a planned interim analysis of the ongoing open-label extension of the Phase 2 trial of its investigational drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the …

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Veracyte to Present New Data Reinforcing Clinical Value of Genomic Tests In Lung Disease Diagnoses

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (NASDAQ: VCYT) announced that new data highlighting the ability of the Percepta Bronchial Genomic Classifier to reduce unnecessary invasive procedures in lung cancer diagnosis will be shared in an oral presentation at CHEST 2018, the annual meeting of the American College of Chest Physicians®. In …

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Theravance Biopharma and Mylan Report New Data from Phase 3 Studies of Yupelri in COPD

DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Sept. 17, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ :TBPH ) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ :MYL ) (“Mylan”) today announced that positive new data from the companies’ Phase 3 clinical program for YUPELRI™ (revefenacin) inhalation solution were featured in an oral presentation …

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Actelion’s Opsumit Significantly Improved Pulmonary Vascular Resistance in First Trial in Portopulmonary Hypertension

ALLSCHWIL, Switzerland–(BUSINESS WIRE)–Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has announced the results of the first randomized controlled trial in portopulmonary hypertension (PoPH), which showed OPSUMIT® (macitentan) significantly improved pulmonary vascular resistance (PVR) compared with placebo, meeting the primary endpoint of the study. Presented as …

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Clinical Trial Data for Nintedanib in Patients with Advanced Idiopathic Pulmonary Fibrosis Published

Ingelheim, Germany, 16 September 2018 – Results from the INSTAGE® trial have been presented at the 2018 European Respiratory Society (ERS) conference in Paris and published in the New England Journal of Medicine.1 The trial reports clinical data on a subset of patients with IPF and severe impairment in gas exchange, for whom only …

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Arena Presents Positive Phase 1 Clinical Data for its Investigational Pulmonary Arterial Hypertension Drug

SAN DIEGO, Aug. 28, 2018 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq : ARNA ) today announced that data from two Phase 1 clinical studies evaluating an extended-release (XR) formulation of its investigative drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of …

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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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