Pulmonary Diseases

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 »

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) …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

Roche Acquires Promedicor for $1.4 Billion, Boosting its Fibrotic Pipeline

LEXINGTON, Mass., Nov. 15, 2019 /PRNewswire/ — Promedior Inc., today announced that it has entered into a definitive merger agreement for Roche(SIX: RO, ROG; OTCQX: RHHBY) to acquire Promedior. With this acquisition, Roche will obtain full rights to Promedior’s entire portfolio of molecules for serious fibrotic diseases, notably PRM-151. Promedior, …

Read More »

FDA Approves Vertex’s Trikafta to Treat the Underlying Cause of Cystic Fibrosis in Patients who Have at Least One F508del Mutation

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most …

Read More »

FDA Grants Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype

RIDGEFIELD, Conn., Oct. 10, 2019 /PRNewswire/ — Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Regulatory applications have been …

Read More »