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Pulmonary Diseases

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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Promedior Receives Breakthrough Therapy Designation from FDA for PRM-151 in Idiopathic Pulmonary Fibrosis

LEXINGTON, Mass., March 26, 2019 /PRNewswire/ — Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that PRM-151, a novel investigational anti-fibrotic immunomodulator, has been granted Breakthrough Therapy designation (BTD) by the U.S. Food and Drug Administration (FDA) for Idiopathic Pulmonary Fibrosis …

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Proteostasis Announces Broad New Dataset from Proprietary Combination and Add-On CFTR Modulator Studies in Cystic Fibrosis

BOSTON, March 25, 2019 /PRNewswire/ — Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, today announced results from Phase 1 clinical studies of its proprietary cystic …

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Boehringer Ingelheim Announces FDA and EMA Regulatory Submission for Nintedanib in Systemic Sclerosis Associated ILD

INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. Nintedanib as an anti-fibrotic medicine is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF). …

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Interim Analysis Showed Treatment with Opsumit Associated with Significant Improvement in Right Ventricular Function and Pulmonary Vascular Resistance in PAH Patients

SOUTH SAN FRANCISCO, Calif. and ALLSCHWIL, Switzerland, March 15, 2019 /PRNewswire/ — Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today an interim analysis from the Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension (REPAIR) study of OPSUMIT® (macitentan) that shows treatment with OPSUMIT …

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Two Phase 3 Studies of the Triple Combination of VX-445, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function in Cystic Fibrosis Patients

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that treatment with the triple combination of the next-generation corrector VX-445, tezacaftor and ivacaftor resulted in statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV1) in two Phase 3 studies in people with cystic fibrosis (CF). …

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Translate Bio Provides Updates on Cystic Fibrosis and Ornithine Transcarbamylase Deficiency Programs

LEXINGTON, Mass., Feb. 27, 2019 (GLOBE NEWSWIRE) — Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, today provided an update on its lead clinical candidate, MRT5005, currently in development for …

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FDA Approves Mylan’s Wixela Inhub, First Generic of Advair Diskus, for Certain Patients with Asthma or COPD

HERTFORDSHIRE, England and PITTSBURGH, Jan. 31, 2019 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) today announced the U.S. Food and Drug Administration (FDA) approval of Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of ADVAIR DISKUS®. Wixela Inhub will launch in the second half of February incorporating the latest safety information required by FDA …

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