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Pulmonary Diseases

Theravance Biopharma’s Trelegy Ellipta Significantly Benefits COPD Patients in Landmark IMPACT Study

DUBLIN, April 19, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today highlighted the publication in the New England Journal of Medicine (NEJM) of the landmark IMPACT study of Trelegy Ellipta in patients with chronic obstructive pulmonary disease (COPD). The IMPACT study is one of the largest trials …

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FDA to Allow Translate Bio to Proceed with Phase 1/2 Clinical Trial in Patients with Cystic Fibrosis

LEXINGTON, Mass.–(BUSINESS WIRE)–Translate Bio, a leading messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company to begin a first-in-human clinical trial of MRT5005 …

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FDA Accepts Theravance and Mylan’s NDA for Revefenacin for the Treatment of Adults with COPD

DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Jan. 29, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ, TASE: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ recently submitted New Drug Application (NDA) for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA). If approved, revefenacin would be the …

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Corsair Pharma and United Therapeutics Collaborate to Advance Novel Treprostinil Prodrugs

SOUTH SAN FRANCISCO, Calif. and SILVER SPRING, Md., Jan. 3, 2018 /PRNewswire/ — United Therapeutics Corporation (NASDAQ: UTHR), a leading biotechnology company focused on development of therapies for the treatment of pulmonary arterial hypertension (PAH), and Corsair Pharma, Inc., a private biopharmaceutical company developing a transdermal treprostinil prodrug, today announced …

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FDA Approves GSK’s Nucala for the Treatment of Eosinophilic Granulomatosis with Polyangiitis

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.  GSK submitted a supplemental Biologics License Application (sBLA) for mepolizumab, an interleukin-5 (IL-5) antagonist, in June …

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Vertex’s Kalydeco Demonstrates Positive Late-Stage Results in Children with Cystic Fibrosis Ages 1 to 2 Years

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from an open-label Phase 3 study of KALYDECO® (ivacaftor) in children with cystic fibrosis (CF) ages 1 to 2 years who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The ARRIVAL study met its primary endpoint …

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Sunovion’s Lonhala Magnair Inhalation Solution Approved by the FDA for Treatment of COPD

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow®, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), …

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Data Confirms Analytical Validity of Veracyte’s Envisia Genomic Classifier for Use in IPF Diagnosis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (NASDAQ: VCYT) announced that data confirming the analytical validity of the company’s Envisia™ Genomic Classifier have been published online in the journal BMC Pulmonary Medicine. The findings add to the growing body of evidence, including previously reported clinical validity and clinical utility data, supporting the use …

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CSL’s Hizentra Meets Primary Endpoint in Phase 3 Study in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

KING OF PRUSSIA, Pa., Nov. 9, 2017 /PRNewswire/ — Global biotherapeutics leader CSL Behring announced that results were published in The Lancet Neurology from its PATH study (Polyneuropathy And Treatment with Hizentra®), a pivotal Phase III study evaluating the safety, efficacy and tolerability of Hizentra (Immune Globulin Subcutaneous [Human] 20% …

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GSK’s Anoro Ellipta Demonstrates Superiority to Stiolto Respimat in Improving Lung Function in COPD

LONDON–(BUSINESS WIRE)–GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced positive data from a study comparing a once-daily long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) fixed-dose combination, Anoro Ellipta (umeclidinium/vilanterol 62.5mcg/25mcg; UMEC/VI) and Stiolto Respimat (tiotropium/olodaterol 5mcg/5mcg; TIO/OLO), for symptomatic patients with chronic obstructive pulmonary disease …

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