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Mylan announces Phase 3 trial of generic fluticasone/salmeterol DPI

According to Mylan, the company will initiate a Phase 3 clinical trial of its generic version of Advair/Seretide Diskus for the treatment of asthma in October 2014, with an expected completion in April 2015. Mylan obtained global rights to the fluticasone/salmeterol inhaler from Pfizer in November 2011. Mylan CEO Heather Bresch commented, "The commencement of … [Read more...] about Mylan announces Phase 3 trial of generic fluticasone/salmeterol DPI

BI presents new data from Phase 3 studies of tiotropium/olodaterol

Boehringer Ingelheim presented data from the 5500-patient, 52-week Phase 3 TONADO studies of tiotropium/olodaterol Respimat for moderate-to-severe COPD at the 2014 ERS International Congress. BI filed an DA for tiotropium/olodaterol Respimat in August 2014. According to BI, the TONADO studies showed statistically significant improvement in lung function for … [Read more...] about BI presents new data from Phase 3 studies of tiotropium/olodaterol

Mundipharma announces new data from Flutiform pediatric study

Mundipharma presented new data from a Phase 3 study of the Flutiform fluticasone/formoterol MDI for the treatment of asthma in children aged 5 to 11 at the European Respiratory Society (ERS) Annual Congress, the company and Flutiform developer Skyepharma announced. Flutiform is not currently approved for pediatric use. The data show superiority of Flutiform … [Read more...] about Mundipharma announces new data from Flutiform pediatric study

Study shows Ultibro Breezhaler significantly reduces exacerbations compared to Advair Diskus (Seretide Accuhaler)

Novartis has announced that its 744-patient randomized, double-blind, 26-week LANTERN study has demonstrated that the once-daily Ultibro Breezhaler indacaterol/glycopyrronium bromide DPI reduced exacerbations in moderate-to-severe COPD patients by 31% compared to twice-daily Advair Diskus (Seretide Accuhaler) salmeterol/fluticasone DPI. The new data were announced … [Read more...] about Study shows Ultibro Breezhaler significantly reduces exacerbations compared to Advair Diskus (Seretide Accuhaler)

Mast announces results from Phase 2 study of Aironite for PAH

Mast Therapeutics has announced that data from an aborted Phase 2 study of AIR001 sodium nitrite inhalation solution for the treatment of pulmonary arterial hypertension (PAH) demonstrated improvement in median pulmonary vascular resistance (PVR) for all doses. Improvements in median distance in a 6-minute walk test were also seen for all doses, "including … [Read more...] about Mast announces results from Phase 2 study of Aironite for PAH

Kamada plans to move ahead with inhaled AAT despite failure to meet endpoints in Phase 2/3 study.

Kamada has announced that still plans to hold discussions with the EMA and FDA regarding regulatory submissions for its inhaled Alpha-1 antitrypsin (AAT) even after the drug failed to meet either its primary or secondary endpoints in a Phase 2/3 clinical study of inhaled AAT for the treatment of Alpha-1 antitrypsin deficiency (AATD). The company said that inhaled … [Read more...] about Kamada plans to move ahead with inhaled AAT despite failure to meet endpoints in Phase 2/3 study.

Phase 1 study of Moerae Matrix’s inhaled MK2 inhibitor initiated

Moerae Matrix has announced the initiation of a Phase 1 clinical trial of MMI-0100, an inhaled MAPKAP Kinase 2 (MK2) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF). In June 2012, the company announced an agreement with MicroDose Therapeutx (now part of Teva) to develop a dry powder inhalation delivery system for the drug. Moerae Matrix CEO … [Read more...] about Phase 1 study of Moerae Matrix’s inhaled MK2 inhibitor initiated

Insmed to proceed with Phase 3 study of Arikayce, will file MAA in 2014

Insmed has announced that it will move ahead with a Phase 3 trial of Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung infections, with results expected in 2017. According to the company, it met with the FDA regarding the study, and "the FDA acknowledged that exploration of the effectiveness of Arikayce in a broader … [Read more...] about Insmed to proceed with Phase 3 study of Arikayce, will file MAA in 2014

Alexza announces plans for development of inhaled ropinirole

Alexza Pharmaceuticals has announced that it will develop Staccato versions of ropinirole, a dopamine agonist, for the treatment of restless leg system (AZ-008) and for the treatment of hypomobility during OFF episodes in Parkinson's disease (AZ-009). The Staccato system uses heat to aerosolize pure API for inhalation. The company said that it also plans to begin a … [Read more...] about Alexza announces plans for development of inhaled ropinirole