Pulmonary Diseases

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 …

Read More »

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 …

Read More »

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 …

Read More »

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, …

Read More »

Acceleron Announces Publication Describing the Underlying Biology Behind Sotatercept’s Potential as a Novel Therapy in PAH

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that research published in the journal Science Translational Medicine describes how a murine version of the investigational agent sotatercept acts to restore balance …

Read More »

A New Report Confirms Significant Benefits in Patient Reported Outcomes at 1-Year Following the Non-Surgical Zephyr Valve Procedure for COPD/Emphysema

REDWOOD CITY, Calif.–(BUSINESS WIRE)–A new publication this month in the Annals of the American Thoracic Society confirms the effectiveness of the Zephyr Valve® in improving dyspnea (shortness of breath), ability to exercise, and quality of life for patients with COPD/emphysema. The Zephyr Valve was the first FDA-approved minimally-invasive bronchoscopic treatment for COPD/emphysema. The Effect …

Read More »

Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sotatercept for the treatment of patients …

Read More »

FDA Approves Boehringer Ingelheim’s Ofev as First Treatment for Chronic Fibrosing ILDs with a Progressive Phenotype

RIDGEFIELD, Conn., March 9, 2020 /PRNewswire/ — Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, sjogren’s syndrome, …

Read More »

FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet in Unclassifiable Interstitial Lung Disease

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Esbriet® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation was granted based on data from a …

Read More »

FDA Grants Fast Track Designation for Translate Bio’s MRT5005 for the Treatment of Cystic Fibrosis

LEXINGTON, Mass., Feb. 26, 2020 (GLOBE NEWSWIRE) — Translate Bio, Inc. (Nasdaq: TBIO), a clinical-stage 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 granted Fast …

Read More »