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Pulmonary Diseases

Phase 3 Study of Savara’s Molgradex Fails to Meet its Primary Endpoint in Patients with Autoimmune Alveolar Pulmonary Proteinosis

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced top line data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP. 138 patients were randomized and received treatment for 24 weeks …

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Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF). Final data announced today from a 24-week Phase 3 study …

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Novartis’ Inhaled Combo Treatment QMF149 Meets Primary and Secondary Endpoints in Phase 3 Study in Patients with Asthma

Basel, May 30, 2019 – Novartis today announced the first study results from the phase III PLATINUM clinical development program assessing the safety and efficacy of QMF149, an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate (IND – a long acting beta agonist [LABA]) and mometasone furoate (MF – an …

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Phase 3 Study Showed Ofev Slows the Loss of Pulmonary Function in People Living with Systemic Sclerosis Associated ILD

RIDGEFIELD, Conn., May 20, 2019 /PRNewswire/ — Boehringer Ingelheim today announced that the SENSCIS® trial met its primary endpoint: reduction in the annual rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). Results showed that Ofev® (nintedanib) slows the loss of …

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Actelion and Owlstone Medical Collaborate to Develop a Breath-Based Test to Help Facilitate Early Detection of Pulmonary Hypertension

CAMBRIDGE, England–(BUSINESS WIRE)–Owlstone Medical, the global leader in Breath Biopsy® for applications in early disease detection and precision medicine today announces a strategic collaboration with Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson and a global leader in pulmonary arterial hypertension (PAH), to discover and …

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Mallinckrodt Announces Encouraging Interim Analysis Results in Phase 4 Registry of INOmax Gas for Inhalation for Pulmonary Hypertension in Neonates

STAINES-UPON-THAMES, United Kingdom, May 6, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced preliminary results of a planned interim analysis from the company’s Phase 4 registry assessing the use of INOmax® (nitric oxide) gas, for inhalation, for premature (27 to less than 34 …

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FDA Approves Kalydeco as First and Only CFTR Modulator to Treat Eligible Infants with Cystic Fibrosis as Early as 6 Months

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

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United Therapeutics’ Esuberaprost Fails to Meet Primary Endpoint in BEAT Study in Patients with Pulmonary Arterial Hypertension

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., April 8, 2019 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the BEAT clinical study of esuberaprost tablets in patients suffering from pulmonary arterial hypertension did not meet its primary endpoint of delayed time to first clinical worsening event. Accordingly, …

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Veracyte Announces Data Published in The Lancet Respiratory Medicine Demonstrate that the Envisia Genomic Classifier Improves Diagnosis of IPF

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. announced that data published online today in The Lancet Respiratory Medicine suggest that use of the company’s Envisia Genomic Classifier improves diagnosis for patients undergoing evaluation for interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF). The Envisia classifier is the first commercially available test that …

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FDA Approves Tudorza Pressair sNDA to Include Data for the Reduction of COPD Exacerbations and Hospitalizations

MORRISVILLE, N.C.–(BUSINESS WIRE)–Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), announced today that the US Food and Drug Administration (FDA) added new data to the TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) Prescribing Information that includes data from the ASCENT trial showing that TUDORZA PRESSAIR reduces exacerbations in chronic obstructive pulmonary disease …

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