Pulmonary Diseases

FDA Accepts Vertex’s sNDA for Trikafta, Symdeko and Kalydeco for Additional CFTR Mutations

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted three supplemental New Drug Applications (sNDAs) for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor). These regulatory submissions are intended to expand the labels for TRIKAFTA, SYMDEKO and KALYDECO to include additional rare CFTR mutations, allowing people …

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AzurRx Announces Positive Interim Data from Phase 2 Trial of MS1819 Plus PERT Therapy in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

NEW YORK, Aug. 11, 2020 (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 results from the first five patients in its Phase 2 combination therapy trial of MS1819 for the treatment of severe …

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AstraZeneca’s Breztri Aerosphere Receives FDA Approval for Maintenance Treatment of COPD

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s BREZTRI AEROSPHERETM (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III ETHOS trial in which BREZTRI AEROSPHERE, a …

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Protalix BioTherapeutics Enters into Non-Binding Term Sheet with SarcoMed USA to Develop alidornase alfa for the Treatment of Pulmonary Sarcoidosis and Related Diseases

CARMIEL, Israel, July 23, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that it has entered into a non-binding term sheet …

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Vertex’s Trikafta Met Primary and Secondary Endpoints in Phase 3 Study in Cystic Fibrosis Patients with One Copy of the F508del Mutation and One Gating or Residual Function Mutation

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of a global Phase 3 study of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people with cystic fibrosis (CF) ages 12 years and older who have one copy of the F508del mutation and one gating mutation (F/G) or one copy of the F508del mutation and one residual function mutation …

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Global Survey Reveals Perceived Burden of Disease is Greater in Younger People Living with COPD

INGELHEIM, Germany–(BUSINESS WIRE)–Results of a global survey of 1,375 adults aged at least 45 years old and living with Chronic Obstructive Pulmonary Disease (COPD) in 11 countries have been published in COPD: Journal of Chronic Obstructive Pulmonary Disease.1 Findings indicate that COPD has a substantial physical and psychosocial impact on patients, …

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PT010 Significantly Reduced Rate of Moderate or Severe COPD Exacerbations in Phase III ETHOS Trial

WILMINGTON, Del.–(BUSINESS WIRE)–Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy PT010 (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Compared with …

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NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 for Treatment of Respiratory Distress in COVID-19

RADNOR, Pa. and GENEVA, June 24, 2020 (GLOBE NEWSWIRE) — NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute …

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Insmed Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis

BRIDGEWATER, N.J., June 8, 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 that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for brensocatib (formerly known as INS1007) for …

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Phase 3 Comparison Study of Novartis’ Enerzair Breezhaler Meets Primary Endpoint in Patients with Uncontrolled Asthma

Basel, June 5, 2020 — Novartis today announced that full results from the Phase IIIb ARGON study were published online in Respiratory Medicine. These results show that once-daily treatment with single inhaler, high- and medium-dose Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) demonstrated non-inferiority to a free combination of twice-daily, …

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