Pulmonary Diseases

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 …

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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 …

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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 …

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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, …

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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 …

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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 …

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United’s Tyvaso Meets Primary and All Secondary Endpoints in Phase 3 Study in Patients with Pulmonary Hypertension with Interstitial Lung Disease

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Feb. 24, 2020 /PRNewswire/ — United Therapeutics Corporation (NASDAQ: UTHR) today announced that preliminary analysis indicates that the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) …

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Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension

SAINT PAUL, Minn.–(BUSINESS WIRE)–Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The Breakthrough Devices Program (BDP) is intended to …

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Insmed Announces Positive Top-Line Results from Phase 2 Study of INS1007 in Patients with Non-Cystic Fibrosis Bronchiectasis

BRIDGEWATER, N.J., Feb. 3, 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 positive top-line results from its global, randomized, double-blind placebo-controlled Phase 2 WILLOW study evaluating the efficacy, safety, and pharmacokinetics of INS1007 administered …

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AstraZeneca Collaborates with Gatehouse Bio to Use its AI-Powered Analytics Platform to Identify Drug Targets in Respiratory and Cardiovascular Diseases

BOSTON–(BUSINESS WIRE)–Gatehouse Bio, a pioneer in next-generation therapeutics, is collaborating with AstraZeneca, a global science-led biopharmaceutical company, to explore the identification of new targets for respiratory and cardiovascular diseases using Gatehouse Bio’s Artificial Intelligence (AI)-powered platform. Gatehouse Bio’s ‘sRNAlytics platform’ identifies novel small RNA (sRNA) signatures and illuminates molecular pathways …

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