Pulmonary Diseases

Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension

SAINT PAUL, Minn.–(BUSINESS WIRE)–Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The Breakthrough Devices Program (BDP) is intended to …

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Insmed Announces Positive Top-Line Results from Phase 2 Study of INS1007 in Patients with Non-Cystic Fibrosis Bronchiectasis

BRIDGEWATER, N.J., Feb. 3, 2020 /PRNewswire/ — Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced positive top-line results from its global, randomized, double-blind placebo-controlled Phase 2 WILLOW study evaluating the efficacy, safety, and pharmacokinetics of INS1007 administered …

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AstraZeneca Collaborates with Gatehouse Bio to Use its AI-Powered Analytics Platform to Identify Drug Targets in Respiratory and Cardiovascular Diseases

BOSTON–(BUSINESS WIRE)–Gatehouse Bio, a pioneer in next-generation therapeutics, is collaborating with AstraZeneca, a global science-led biopharmaceutical company, to explore the identification of new targets for respiratory and cardiovascular diseases using Gatehouse Bio’s Artificial Intelligence (AI)-powered platform. Gatehouse Bio’s ‘sRNAlytics platform’ identifies novel small RNA (sRNA) signatures and illuminates molecular pathways …

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Roche Acquires Promedicor for $1.4 Billion, Boosting its Fibrotic Pipeline

LEXINGTON, Mass., Nov. 15, 2019 /PRNewswire/ — Promedior Inc., today announced that it has entered into a definitive merger agreement for Roche(SIX: RO, ROG; OTCQX: RHHBY) to acquire Promedior. With this acquisition, Roche will obtain full rights to Promedior’s entire portfolio of molecules for serious fibrotic diseases, notably PRM-151. Promedior, …

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FDA Approves Vertex’s Trikafta to Treat the Underlying Cause of Cystic Fibrosis in Patients who Have at Least One F508del Mutation

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most …

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FDA Grants Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype

RIDGEFIELD, Conn., Oct. 10, 2019 /PRNewswire/ — Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Regulatory applications have been …

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Savara Announces FDA Response From Type C Meeting on Molgradex for aPAP Development Program

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced the response from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Molgradex development program for autoimmune pulmonary alveolar proteinosis (aPAP). Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). …

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FibroGen Announces Publication of Positive Pamrevlumab Efficacy and Safety Data for the Praise Phase 2 Study in Idiopathic Pulmonary Fibrosis

SAN FRANCISCO, Sept. 30, 2019 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) today announced publication in The Lancet Respiratory Medicine of positive results from the company’s PRAISE Phase 2 clinical study of the efficacy and safety of pamrevlumab, a fully human recombinant monoclonal antibody against connective tissue growth factor (CTGF), for treatment …

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AzurRx BioPharma Announces Positive Results from Phase 2 Trial of MS1819 in Cystic Fibrosis Patients

NEW YORK, Sept. 25, 2019 (GLOBE NEWSWIRE) — AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced positive safety results from its Phase II OPTION Clinical Trial of MS1819 for the treatment of exocrine pancreatic insufficiency …

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FDA Approves Ofev, the First and Only Therapy to Slow the Rate of Decline in Pulmonary Function in Patients with Sclerosis-Associated ILD

Ridgefield, Conn., September 06, 2019 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Ofev is already approved in the …

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