Medical

Verona Pharma says that the company will present data at the upcoming North American Cystic Fibrosis Conference showing that its RPL554 inhaled PDE3/PDE4 inhibitor could be useful in treating CF. According to the company, "The presentation, entitled 'CFTR activation by the dual phosphodiesterase 3/4 inhibitor RPL554 and the MRP4 inhibitor MK571,' reports data … [Read more...] about Verona says RPL554 could treat cystic fibrosis

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

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 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

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 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 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.