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Pulmonary Diseases

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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Global Blood Therapeutics Discontinues Development of Idiopathic Pulmonary Fibrosis Program

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2017 (GLOBE NEWSWIRE) — Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT) today announced the discontinuation of its GBT440 program for the treatment of idiopathic pulmonary fibrosis (IPF). This decision is based on results from three proof-of-concept studies including a Phase 1 study in healthy volunteers …

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Acceleron Amends Agreement with Celgene, Taking Back Rights to PAH Candidate Sotatercept

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today announced it has amended the sotatercept development and commercialization collaboration agreement with Celgene Corporation, originally executed on February 20, 2008. The amended agreement provides Acceleron …

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FDA Grants Priority Review to Vertex’s Combination Therapy for Treatment of Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the acceptance of its applications for the use of the tezacaftor/ivacaftor combination treatment in people with cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation or one F508del mutation and one residual function mutation that is responsive to tezacaftor/ivacaftor by the …

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AstraZeneca Enters Respiratory Disease mRNA Collaboration with Ethris

MUNICH & GAITHERSBURG, Md.–(BUSINESS WIRE)–Ethris GmbH, a leader in mRNA-based therapeutics with specific expertise in pulmonary disease, today announced a five-year strategic research collaboration with AstraZeneca and its global biologics research and development arm, MedImmune. The collaboration is focused on developing new stabilised non-immunogenic modified RNA therapies for respiratory diseases …

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Fluidigm Licenses CFTR NGS Assay from Baylor Genetics for Use with the Juno System

SOUTH SAN FRANCISCO, Calif., Aug. 17, 2017 (GLOBE NEWSWIRE) — Fluidigm Corporation (NASDAQ:FLDM) and Baylor Genetics today announced that they have entered into a licensing agreement to offer a next-generation sequencing (NGS) library prep assay that enables efficient sequencing of the CFTR (cystic fibrosis transmembrane conductance regulator) gene. Under the …

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FibroGen’s Pamrevlumab Succeeds in Mid-Stage Idiopathic Pulmonary Fibrosis Study

SAN FRANCISCO, Aug. 07, 2017 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, announced today positive topline results from the company’s Phase 2 randomized, double-blind, placebo-controlled study and two combination safety sub-studies of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF). Pamrevlumab is a proprietary, first-in-class, anti-connective tissue growth factor (CTGF) antibody being …

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FDA Approves Vertex’s Kalydeco for 600+ Cystic Fibrosis Patients with One of Five Residual Mutations

BOSTON–(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO® (ivacaftor) for use in more than 600 people with cystic fibrosis (CF) ages 2 and older who have one of five residual function mutations that result in a splicing defect in the cystic fibrosis …

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Vertex Announces Positive Results for Cystic Fibrosis Triple Combos

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive data from Phase 1 and Phase 2 studies of three different triple combination regimens in people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min). These are the first data to demonstrate the potential to treat the underlying …

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