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Pulmonary Diseases

AstraZeneca’s Fasenra Fails in Late-Stage Chronic Obstructive Pulmonary Disease Trial

AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with …

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Vertex Initiates Late-Stage Studies for its Triple Combination Regimen for Patients with Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it is initiating two Phase 3 studies of VX-445, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF). The first Phase 3 study will evaluate approximately 360 people with CF who have one copy of the F508del mutation …

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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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