European Respiratory Society

U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Friday, March 22, 2024
Diagnosis, ESC, Toxicity, ERA, Tadalafil, Internal medicine, European Respiratory Society, Disease, Risk, Pulmonary hypertension, Patient, PVR, Mitigation, Female, Nitric oxide, Connective tissue disease, Orthostatic hypertension, World Health Organization, PDE5, Johnson & Johnson, REMS, WHO, Pulmonary circulation, PAH, FDA, Constriction, ERS, Food, Pharmaceutical industry

RARITAN, N.J., March 22, 2024  /PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.1 OPSYNVI® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.1

Key Points: 
  • Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available," said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.
  • The FDA's approval of OPSYNVI® is based on the results from the pivotal Phase 3 A DUE study , in which OPSYNVI® demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.
  • "People with PAH often live with the burden of taking many pills each day, which can pose challenges," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson.
  • "We're thrilled to bring this single-tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment."

EQS-News: AATec Medical appoints Professor Dr. Claus Franz Vogelmeier to the Scientific Advisory Board

Retrieved on: 
Wednesday, March 13, 2024
Bronchiectasis, American Journal, Pulmonology, Asthma, AAT, European Respiratory Society, FERS, GOLD, Patient, Chronic obstructive pulmonary disease, Global Initiative, German Respiratory Society, Critical Care Medicine (journal), COPD, Pharmaceutical industry

AATec Medical appoints Professor Dr. Claus Franz Vogelmeier to the Scientific Advisory Board

Key Points: 
  • AATec Medical appoints Professor Dr. Claus Franz Vogelmeier to the Scientific Advisory Board
    The issuer is solely responsible for the content of this announcement.
  • AATec Medical appoints Professor Dr. Claus Franz Vogelmeier to the Scientific Advisory Board
    Leading pulmonology expert contributes profound clinical experience in inflammatory lung diseases such as bronchiectasis, COPD, asthma, and ARDS to AATec Medical.
  • Munich, Germany – 29.02.2024 – AATec Medical GmbH (AATec), a biotech company developing a multi-product platform technology based on recombinant alpha-1 antitrypsin (AAT), today announced the appointment of Prof. Dr. Claus Franz Vogelmeier, Professor of Medicine and Head of the Department of Pulmonary Medicine at Philipps-University in Marburg, Germany to its Scientific Advisory Board.
  • Dr. Rüdiger Jankowsky, co-founder and CEO of AATec, commented: “We are very pleased to welcome Professor Vogelmeier to our Scientific Advisory Board.

aTyr Pharma Announces Third Quarter 2023 Results and Provides Corporate Update

Retrieved on: 
Thursday, November 9, 2023
NRP2, Research, Safety, SAN, Neuropilin, PST, D, BLA, Sarcoidosis, ILD, Scleroderma, International, Investment, Systemic scleroderma, ERS, Clinical trial, Patient, European Respiratory Society, DSMB, Rheumatoid arthritis, ATyr Pharma, American College, American College of Rheumatology, Small RNA, The Journal, Frontiers, Skin, ACR, Poster, Biologics license application, Pharmaceutical industry, Pharmacology, Kyorin

SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2023 results and provided a corporate update.

Key Points: 
  • Ended the third quarter of 2023 with $105.6 million in cash, cash equivalents and investments.
  • SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2023 results and provided a corporate update.
  • Based on current enrollment projections, the Company expects to complete enrollment in the study early in the second quarter of 2024.
  • G&A Expenses: General and administrative expenses were $2.6 million for the third quarter of 2023.

Arrowhead Pharmaceuticals Reports Fiscal 2023 Year End Results

Retrieved on: 
Wednesday, November 29, 2023
Oncology, Health, Genetics, General Health, Pharmaceutical, Cardiology, Biotechnology, Webcast, Hypertriglyceridemia, GLP, Johnson & Johnson, Janssen Pharmaceuticals, Toxicology, International, RNA interference, Heart, AHA, GSK plc, Cholesterol, PIN, ERS, Patient, Cleveland Clinic, European Respiratory Society, Idiopathic pulmonary fibrosis, American Heart Association, GSK, MD, Janssen, Doctor of Philosophy, ANGPTL3, Triglyceride, Pharmaceutical industry, Medical device, Arrowhead, Medicine, APOC3

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal year ended September 30, 2023.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal year ended September 30, 2023.
  • The company is hosting a conference call today, November 29, 2023, at 4:30 p.m.
  • ET to discuss the results.
  • JNJ-3989 (formerly ARO-HBV) was initially in-licensed by Janssen from Arrowhead in 2018

ResMed Inc. Announces Results for the First Quarter of Fiscal Year 2024

Retrieved on: 
Thursday, October 26, 2023
Astral, ERS, Airview Historic District, Australian Securities Exchange, CDI, NYSE, CHESS, ASV, OSA, Physician, Congress, Acquisition, DAN, Webcast, Sleep, European Respiratory Society, NIV, ResMed, Software as a service, Cryptocurrency, Health care, Video game, Pharmaceutical industry, CPAP

SAN DIEGO, Oct. 26, 2023 (GLOBE NEWSWIRE) -- ResMed Inc. (NYSE: RMD, ASX: RMD) today announced results for its quarter ended September 30, 2023.

Key Points: 
  • Revenue grew by 15 percent on a constant currency basis, driven by increased demand for our sleep and respiratory care devices.
  • Revenue in Europe, Asia, and other markets, excluding Software-as-a-Service, grew by 18 percent on a constant currency basis.
  • SG&A expenses improved to 20.2 percent of revenue in the quarter, compared with 20.4 percent in the same period of the prior year.
  • ResMed will discuss its first-quarter fiscal year 2024 results on its webcast at 1:30 p.m. U.S. Pacific Time today.

Bristol Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for Investigational LPA1 Antagonist for Progressive Pulmonary Fibrosis

Retrieved on: 
Tuesday, October 24, 2023
FDA, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, LPA1, BMY, Bristol Myers Squibb, ERS, Second International Congress on Education of the Deaf, LPAR1, Pulmonary fibrosis, Respiratory failure, NYSE, Food, Breakthrough, Head, MD, PPF, Idiopathic pulmonary fibrosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IPF, Circulatory system, Quality of life, Vital capacity, Safety, European Respiratory Society, Death, Pharmaceutical industry, Immunology

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF), a devastating, life-threatening illness.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF), a devastating, life-threatening illness.
  • The Breakthrough Therapy Designation is based on results from the global, randomized Phase 2 study that assessed the safety and efficacy of BMS-986278 treatment versus placebo in people living with idiopathic pulmonary fibrosis (IPF) and PPF.
  • “The FDA’s Breakthrough Therapy Designation underscores the potential of BMS-986278 as an innovative, first-in-class treatment that may redefine the standard of care for progressive pulmonary fibrosis.”
    In addition to this Breakthrough Therapy Designation for PPF, the U.S. FDA has also previously granted BMS-986278 fast-track designation and orphan drug designation for the treatment of IPF.
  • Bristol Myers Squibb is continuing the development of BMS-986278 with the global Phase 3 ALOFT program for PPF ( NCT06025578 ) and IPF ( NCT06003426 ).

BiomX Announces Completion of Patient Dosing in Part 2 of the Phase 1b/2a Study Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

Retrieved on: 
Wednesday, October 4, 2023
Part 1, Trial of the century, Phage therapy, Cystic fibrosis, Part, ECFS, Fright Night Part 2, ERS, Pseudomonas aeruginosa, Congress, Patient, Randomness, Nebulizer, European Respiratory Society, NESS, CF, NYSE, Pharmaceutical industry

CAMBRIDGE, Mass. and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”). The Company remains on track to report results from Part 2 of the study in November 2023.

Key Points: 
  • and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”).
  • The Company remains on track to report results from Part 2 of the study in November 2023.
  • “BX004 has been designed to address a significant unmet need facing thousands of CF patients who require new treatments to combat persistent and deadly lung infections,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • “With patient dosing now complete in Part 2 of our Phase 1b/2a study, we remain on track to announce results next month.

Aerami Therapeutics Announces Presentation of Phase 1 Clinical Trial Data for Lead Program AER-901 at the 2023 European Respiratory Society (ERS) International Congress

Retrieved on: 
Tuesday, September 12, 2023
Inhalation, Mico, PAH, Lung, ERS, Congress, HIV disease progression rates, Novartis, European Respiratory Society, UniPhi, Orthostatic hypertension, Pulmonary hypertension, Second International Congress on Education of the Deaf, Safety, Disease, Pharmaceutical industry

The ERS International Congress is being held September 9-13, 2023, at the MiCo convention center in Milan, Italy.

Key Points: 
  • The ERS International Congress is being held September 9-13, 2023, at the MiCo convention center in Milan, Italy.
  • The oral presentation and e-poster are available through the conference portal and will be posted to the Aerami website following the meeting.
  • In a Phase 3 clinical trial sponsored by Novartis, oral imatinib demonstrated substantial efficacy when added to 2 or 3 background standard-of-care medications for PAH.
  • Clinical data presented at the 2023 ERS International Congress include safety, tolerability, and pharmacokinetic results from the AER-901 Phase 1 trial.

Avalyn Pharma Presents Data Showing Favorable Tolerability and Potential of AP01 to Preserve Forced Vital Capacity in Adults with Pulmonary Fibrosis

Retrieved on: 
Tuesday, September 12, 2023
Lazarus, AE, Diarrhea, Atmosphere, Indigestion, PPF, Appetite, Meta-analysis, Rash, ERS, Pulmonary fibrosis, Vomiting, Incidence, Literature, Vital capacity, ASCEND, Patient, Physician, European Respiratory Society, St Thomas' Hospital, FCCP, Nausea, Guy, Hospital, Guy Henry Faget, IPF, Idiopathic pulmonary fibrosis, Ulster University School of Law, Pharmaceutical industry, FVC

Forced vital capacity (FVC) measures the amount of air a person can forcibly exhale and is used by physicians to monitor progression of pulmonary fibrosis.

Key Points: 
  • Forced vital capacity (FVC) measures the amount of air a person can forcibly exhale and is used by physicians to monitor progression of pulmonary fibrosis.
  • Participants with idiopathic pulmonary fibrosis (IPF) who were treated with AP01 experienced a less profound reduction in FVC than has been reported with oral pirfenidone.
  • Adults treated with AP01 also reported markedly lower rates of nausea, rash, diarrhea, dyspepsia and vomiting compared to the published side-effect profile of oral pirfenidone.
  • Similarly, statistical significance would also be observed vs the placebo arms of the INPULSIS-1, INPULSIS-2 and INBUILD studies of oral nintedanib.

Pliant Therapeutics Announces Presentations at the European Respiratory Society International Congress 2023

Retrieved on: 
Monday, September 11, 2023
European Respiratory Society, International, Therapy, Week, Serum, RNA-Seq, Safety, FVC, Fibroblast, QLF, ERS, Fibrosis, Vital capacity, Patient, SAN, Congress, IPF, International Congress on Tuberculosis, Idiopathic pulmonary fibrosis, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced presentations made at the European Respiratory Society (ERS) International Congress 2023 taking place from September 9, 2023 to September 13, 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced presentations made at the European Respiratory Society (ERS) International Congress 2023 taking place from September 9, 2023 to September 13, 2023.
  • “We are pleased to be sharing non-clinical and clinical data at this important congress, including, for the first time at a scientific session, the final results from our INTEGRIS-IPF Phase 2a trial.
  • Data from this trial support the late-stage development of bexotegrast as part of the BEACON-IPF trial and highlight our commitment to developing potential treatments for fibrotic diseases,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics.
  • Further analysis of circulating integrin β6 in clinical trials may help to better characterize its utility as an early biomarker of response to anti-fibrotic therapy.