Kamada has announced that preliminary results from its Phase 2/3 pivotal trial of its inhaled Alpha-1 Antitrypsin (AAT) therapy showed no difference between inhaled AAT and placebo in “time to first moderate or severe exacerbation,” the primary endpoint. The 50-week study involved 168 patients. The company said that the frequency of severe exacerbations in patients … [Read more...] about Kamada pivotal study of inhaled AAT fails to meet primary endpoint
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Aptar publishes summary of roundtable on inhaler adherence
Aptar Pharma has published a white paper summarizing a roundtable discussion on inhaler adherence held in Paris, France on November 29th 2013. The panel included five experts on inhaler usage from the UK and France. The company said, "Aptar Pharma and its distinguished scientific guests were delighted with the successful outcome of the inhaler adherence … [Read more...] about Aptar publishes summary of roundtable on inhaler adherence
Positive Phase 1b results for Pulmatrix LAMA DPI
Pulmatrix has announced that a recently completed Phase 1b study of its PUR0200 inhaled LAMA in COPD patients found that all three doses of PUR0200 produced significant improvement in lung function compared to placebo and comparable or greater to an active comparator. The company had announced initiation of the study in July 2013. PUR0200 is a carrier-free dry … [Read more...] about Positive Phase 1b results for Pulmatrix LAMA DPI
Clinical trials underway for inhaled immune system stimulant
According to an announcement from the Texas A&M Health Science Center (TAMHSC), Texas-based biotech Pulmotect has initiated clinical trials of PUL-042, an inhaled immune system stimulant. In 2012, the company received a grant of over $7 million for development of PUL-042, which was designed by researchers at TAMHSC and the University of Texas MD Anderson Cancer … [Read more...] about Clinical trials underway for inhaled immune system stimulant
VR1 presents poster on intranasal capsaicin for headache
The makers of a homeopathic capsaicin nasal spray are presenting a poster featuring "real-world patient case series analysis supporting the use of intranasal capsaicin as an effective rapid treatment for severe headache and migraine pain" at the 2014 American Academy of Neurology (AAN) Annual Meeting. VR1, Inc. recently launched an intranasal capsaicin product, … [Read more...] about VR1 presents poster on intranasal capsaicin for headache
Novartis announces positive results from Phase 3 study of Ultibro vs Seretide (Advair)
Data from a 26-week head-to-head Phase 3 study show that the Ultibro Breezhaler indacaterol/glycopyrronium DPI produced greater improvement in the lung function of COPD patients with or without a history of moderate-to-severe exacerbations compared to Seretide Accuhaler (Advair Diskus), Novartis has announced. The company says that it intends to file a regulatory … [Read more...] about Novartis announces positive results from Phase 3 study of Ultibro vs Seretide (Advair)
NanoBio to present data on intranasal herpes vaccine
NanoBio Corporation has announced that it will present promising pre-clinical study data of its nano-emulsion (NE)-adjuvanted intranasal herpes simplex virus-2 (HSV-2) vaccine at the Annual Conference on Vaccine Research. NanoBio Senior VP of Vaccine Research Ali Fattom explained that the company "will present data from pre-clinical guinea pig studies … [Read more...] about NanoBio to present data on intranasal herpes vaccine
Positive Phase 2b results for Civitas Therapeutics’ inhaled L-dopa
Civitas Therapeutics has announced positive results from a Phase 2b trial of its CVT-301 inhaled L-dopa for the treatment of Parkinson's disease symptoms. The company is developing CVT-301 based on its proprietary ARCUS particle engineering and dry powder inhaler technology. The randomized, double-blind study involved 86 Parkinson's patients at multiple study … [Read more...] about Positive Phase 2b results for Civitas Therapeutics’ inhaled L-dopa
New Phase 3 study of FF/VI for COPD announced
GSK and Theravance have announced a Phase 3 study of fluticasone furoate (FF)/vilanterol (VI) (the Relvar Ellipta DPI) including Japanese COPD patients. In July 2013, GSK withdrew its application for Relvar for the treatment of COPD in Japan because the available Japanese patient data at the time showed that the FF component failed to produce a statistically … [Read more...] about New Phase 3 study of FF/VI for COPD announced
Genoa announces additional positive results for inhaled pirfenidone
Genoa Pharmaceuticals has announced that studies conducted in conjunction with McMaster University have shown that peak pirfenidone activity can be achieved by lung levels of the drug that remain for only a short period of time. Genoa previously announced that its GP-101 inhaled pirfenidone demonstrated greater anti-fibrotic effects with smaller doses than oral … [Read more...] about Genoa announces additional positive results for inhaled pirfenidone