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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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Actelion Receives Complete Response Letter from FDA for Opsumit sNDA for the Treatment of CTEPH

SOUTH SAN FRANCISCO, Calif., Jan. 16, 2019 /PRNewswire/ — Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for OPSUMIT® (macitentan) in …

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Vertex and Arbor Partner to Discover Novel Proteins to Advance Discovery of Gene-Editing Therapies for Cystic Fibrosis

BOSTON & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) and Arbor Biotechnologies (Arbor) today announced that the two companies have entered into a strategic research collaboration focused on the discovery of novel proteins including DNA endonucleases to advance the development of new gene-editing therapies for cystic fibrosis and four other diseases …

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FDA Approves First and Only Digital Inhaler with Built-in Sensors – ProAir Digihaler Inhalation Powder

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to …

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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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