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FDA Grants Breakthrough Device Designation to Artificial Intelligence Software for CTEPH Pattern Recognition from Bayer and MSD

Berlin, December 3, 2018 – Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition, which Bayer is currently developing jointly with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA). A …

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Two Phase 3 Studies of the Triple Combination of VX-659, 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-659, 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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Arena Pharmaceuticals and United Therapeutics Announce Global License Agreement for Arena’s Investigational PAH Drug Ralinepag

SAN DIEGO and RESEARCH TRIANGLE PARK, N.C., Nov. 15, 2018 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and United Therapeutics Corporation (Nasdaq: UTHR) today announced that the companies have entered into a global license agreement for Arena’s Phase 3 investigational 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 Yupelri for Maintenance Treatment of Adult Patients with COPD

DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for YUPELRITM (revefenacin) inhalation solution for the maintenance treatment of patients …

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AbbVie Assumes Full Development and Commercial Control of Galapagos’ Cystic Fibrosis Assets

NORTH CHICAGO, Ill., Oct. 24, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that it will assume full development and commercial responsibility for its collaboration with Galapagos (Euronext: GLPG) to discover and develop new therapies to treat cystic fibrosis (CF). AbbVie’s research program aims to develop a …

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Vertex Data Presented at NACFC Demonstrate Rapid Progress Toward Expanding and Enhancing Options for Treating Cystic Fibrosis

DENVER–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that eight scientific abstracts from the company’s portfolio of cystic fibrosis (CF) medicines are being presented at the 32nd North American Cystic Fibrosis Conference taking place October 18-20, 2018 in Denver. Key highlights include presentations of Phase 2 data evaluating clinical safety and efficacy …

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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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