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Pulmonary Diseases

FDA Accepts Vertex’s NDA for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combo Treatment for Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen. The FDA has granted Priority Review of the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action …

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Nabriva’s Xenleta Receives FDA Approval for Treatment of Community-Acquired Bacterial Pneumonia

DUBLIN, Ireland, Aug. 19, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and …

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CureVac and Yale University Partner for Discovery Research in mRNA-Based Lung Therapy Candidates

TÜBINGEN, Germany and BOSTON, Aug. 13, 2019 (GLOBE NEWSWIRE) — CureVac AG, a fully integrated biopharmaceutical company pioneering the field of mRNA-based drugs, announced today it has entered into a Collaborative Research Agreement (“CRA”) with Yale University for discovery research into mRNA-based pulmonary therapeutic candidates.  The exclusive CRA covers the …

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Translate Bio Announces Interim Results from Phase 1/2 Clinical Trial of MRT5005 in Patients with Cystic Fibrosis

LEXINGTON, Mass., July 31, 2019 (GLOBE NEWSWIRE) — Translate Bio (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 interim results from a first-in-human Phase 1/2 clinical trial evaluating single and …

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Zambon Completes Acquisition of Respiratory Disease Drugmaker Breath Therapeutics

MILAN–(BUSINESS WIRE)–Zambon, a multinational pharmaceutical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives, announces the acquisition of Breath Therapeutics and its subsidiaries for € 140 million (up to total € 500 million subject to regulatory and sales milestones). …

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FDA Advisory Committee Recommends Approval of Boehringer Ingelheim’s Ofev for the Treatment of Systemic Sclerosis Associated with ILD

RIDGEFIELD, Conn., July 25, 2019 /PRNewswire/ — Boehringer Ingelheim today announced that the FDA’s Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev® (nintedanib) for the treatment of systemic sclerosis associated interstitial lung disease, or SSc-ILD. “The committee’s recommendation brings nintedanib one step closer to becoming available to patients who …

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Vertex Submits NDA to the FDA for Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor in Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen. The NDA includes a request for Priority Review, which, if granted, would shorten the FDA’s review of …

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Boehringer Ingelheim Expands Idiopathic Pulmonary Fibrosis Pipeline Through Collaboration and License Agreement with Bridge Biotherapeutics

INGELHEIM, Germany & SEONGNAM, Korea–(BUSINESS WIRE)–Boehringer Ingelheim and Bridge Biotherapeutics Inc. today announced that they are entering into a new collaboration and license agreement with the goal of developing Bridge Biotherapeutics’s autotaxin inhibitor BBT-877 for patients with fibrosing interstitial lung diseases, including IPF. BBT-877 is currently in Phase I clinical studies and …

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Phase 3 Study of Savara’s Molgradex Fails to Meet its Primary Endpoint in Patients with Autoimmune Alveolar Pulmonary Proteinosis

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced top line data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP. 138 patients were randomized and received treatment for 24 weeks …

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Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF). Final data announced today from a 24-week Phase 3 study …

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