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)
Medical
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
Phase 3 study of triple combination DPI underway
GlaxoSmithKline and Theravance have announced the commencement of a Phase 3 study of a triple combination inhaled therapy delivered using the Ellipta DPI for the treament of COPD. The triple therapy combines fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI). The 52-week study will involve approximately 10,000 patients in 38 countries who will … [Read more...] about Phase 3 study of triple combination DPI underway
NHS apologizes for mis-coding Relvar Ellipta
The UK National Health Service Prescription Services has apologized for mistakenly classifying two versions of the Relvar Ellipta fluticasone/vilanterol DPI under the wrong British National Formulary (BNF) code in its database. The two products involved are 184mcg/22mcg and 92mcg/22mcg dosage strengths of Relvar. According to the NHS Business Services Authority, … [Read more...] about NHS apologizes for mis-coding Relvar Ellipta
Brovana inhalation solution safety study data published
Sunovion Pharmaceuticals has announced publication of data from a year-long safety study showing an approximately 40% lower risk of COPD exacerbation-related hospitalization or death due to respiratory disease for patients using Brovana arformoterol tartrate inhalation solution than for patients using a placebo. The data were published online in Chest on June 26, … [Read more...] about Brovana inhalation solution safety study data published
Respiratory Technology Group at WIMR gets grant for development of inhaled vaccines
The Australian Research Council (ARC) has awarded a 3-year, $482,738 linkage grant titled "One for all and all for one- Engineering a drug delivery platform for DNA vaccines to the lung" to members of the Respiratory Technology team at the Woolcock Institute of Medical Research (WIMR) and Evonik Industries. The partnership aims to develop a new, low-cost technology … [Read more...] about Respiratory Technology Group at WIMR gets grant for development of inhaled vaccines