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Medical

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

Milestone’s intranasal calcium channel antagonist gets generic name “etripamil”

Milestone Pharmaceuticals has announced today that its MSP-2017 intranasal calcium channel antagonist has been assigned the unique non-proprietary name "etripamil" by the United States Adopted Name (USAN) Council. The company is developing the etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone CEO Philippe Douville … [Read more...] about Milestone’s intranasal calcium channel antagonist gets generic name “etripamil”

Neurelis announces initiation of pivotal trials for intranasal diazepam

Neurelis says that it has received guidance from the FDA regarding clinical trial requirements for the company's NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients and is now initiating the pivotal trial program for the product. Neurelis President and CEO Craig C. Chambliss commented, "We were pleased to obtain guidance … [Read more...] about Neurelis announces initiation of pivotal trials for intranasal diazepam

Turing says that it is initiating Phase 1 clinical trials for intranasal ketamine

Turing Pharmaceuticals said that it has received a no objection letter from Health Canada regarding the initiation of Phase 1 trials of TUR-002 intranasal ketamine for the reduction of suicidal ideations and that it expects to complete the trials by mid-2016. The timing is in line with a November 2015 announcement from Turing that was made prior to the arrest and … [Read more...] about Turing says that it is initiating Phase 1 clinical trials for intranasal ketamine

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