Verona Pharma has announced positive data from a Phase 2a study of RPL554, an inhaled PDE3/PDE4 inhibitor for the treatment of acute exacerbations in COPD patients. According to the company, asthma patients who received the nebulized RPL554 experienced no serious adverse events over the entire dose range of 0.4 to 24 mg and demonstrated a maximum bronchodilator effect … [Read more...] about Verona announces positive data from Phase 2a trial of RPL554
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Grant available for deposition study
The US Department of Health and Human Services has announced that a grant of up to $200,000 is available for "Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug Products." One grant will be awarded. According to the March 15, 2016 announcement, "FDA's CDER is seeking depositional data obtained with a computational modeling … [Read more...] about Grant available for deposition study
Sunovion study shows that COPD patients receive DPIs despite insufficient inspiratory flow rate
Sunovion is presenting observational study data at the Hospital Medicine 2016 conference showing that a substantial number of COPD patients are discharged from hospitals with a prescription for a dry powder inhaler despite their inability to generate sufficient peak inspiratory flow for optimal use of the device. Data from a second study show worse COPD-related … [Read more...] about Sunovion study shows that COPD patients receive DPIs despite insufficient inspiratory flow rate
BI presents data showing Spiriva Respimat effective when added to other asthma therapies
Boehringer Ingelheim has presented data at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting showing that the Spiriva Respimat tiotropium bromide soft mist inhaler improves lung function and reduces exacerbations when added to other treatments for all allergic asthma subtypes. The addition of Spiriva Respimat also improved asthma … [Read more...] about BI presents data showing Spiriva Respimat effective when added to other asthma therapies
Study shows significant overdiagnosis of asthma in children
A study published in the British Journal of General Practice titled "Overdiagnosis of asthma in children in primary care: a retrospective analysis" found that over half of children diagnosed with asthma at several major healthcare centers in the Netherlands probably do not have the disease. Researchers from Julius Health Care Center and University Medical Center … [Read more...] about Study shows significant overdiagnosis of asthma in children
Japanese authorities approve Phase 2/3 trial of inhaled molgramostim
Serendex Pharmaceuticals has announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved the company's planned IMPALA Phase 2/3 clinical trial of Molgradex inhaled molgramostim for pulmonary alveolar proteinosis (PAP). According to the company, the trial has already been approved in Denmark and the Netherlands, and will also include … [Read more...] about Japanese authorities approve Phase 2/3 trial of inhaled molgramostim
Positive Phase 2b results for Ockham’s inhaled heparin for COPD
UK-based Ockham Biotech has announced that data from a Phase 2b study of its inhaled heparin for the treatment of COPD demonstrate significant improvement in lung function compared to placebo, with improvements maintained for 7 days after cessation of treatment and no adverse events. The study involved 24 moderate-to-severe COPD patients who received either … [Read more...] about Positive Phase 2b results for Ockham’s inhaled heparin for COPD
Discovery Labs appoints Craig Fraser as President and CEO, provides update on Aerosurf program
Discovery Laboratories, which recently released positive Phase 2a data for its Aerosurf aerosolized KL4 surfactant and advanced the product into Phase 2b, has announced the appointment of Craig Fraser as President and CEO. Fraser was most recently Chief Operating Officer of Aegerion Pharmaceuticals and previously held positions at Pfizer, Wyeth, and Johnson & Johnson. … [Read more...] about Discovery Labs appoints Craig Fraser as President and CEO, provides update on Aerosurf program
Pulmatrix bioequivalence study of PUR0200 gets underway
Pulmatrix has announced that a pilot bioequivalence study of 5 formulations of its PUR0200 DPI for the treatment of COPD has begun enrollment. The company is partnered with Mylan on development of the DPI. According to Pulmatrix, enrollment of 42 healthy volunteers for the study should be completed by the end of the first quarter of 2016, and results should be … [Read more...] about Pulmatrix bioequivalence study of PUR0200 gets underway
Positive Phase 2a results for Mast’s AIR001 for the treatment of heart failure
Mast Therapeutics says that top-line results from a Phase 2a study of its AIR001 sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) demonstrated statistically significant change in pulmonary capillary wedge pressure (PCWP) during exercise compared to placebo, which was the primary endpoint. Mast acquired … [Read more...] about Positive Phase 2a results for Mast’s AIR001 for the treatment of heart failure