Generex Biotechnology has announced an agreement with NHTherapeutics to co-develop a formulation of leuprolide for delivery by Generex's RapidMist buccal aerosol technology. Leuprolide is a gonadotropin-releasing hormone (GnRH) analog which is currently approved at higher dosage levels for the treatment of conditions such as prostate cancer and endometriosis; NHT is … [Read more...] about Generex to co-develop buccal aerosol formulation of leuprolide for NHTherapeutics
News
FDA approves Stiolto Respimat for the treatment of COPD
According to Boehringer Ingelheim, the FDA has approved its tiotropium bromide/olodaterol soft mist inhaler for the treatment of COPD. The company filed an NDA for the product, which will be marketed as Stiolto Respimat Inhalation Spray, in August 2014. New data analyses from Phase 3 studies showing improved lung function for patients using the combination … [Read more...] about FDA approves Stiolto Respimat for the treatment of COPD
Positive results from Phase 3 trials of NVA237 and QVA149
Novartis has announced positive results from several Phase 3 studies of NVA237 glycopyrronium bromide and QVA149 indacaterol/glycopyrronium bromide, both delivered by the Breezhaler DPI for the treatment of COPD. NVA237 is marketed as Seebri Breezhaler outside of the US, and QVA149 is marketed as Ultibro Breezhaler outside of the US. According to the data presented … [Read more...] about Positive results from Phase 3 trials of NVA237 and QVA149
Sunovion announces results of Brovana studies
Sunovion Pharmaceuticals has presented results from three studies of Brovana arformoterol tartrate inhalation solution for the treatment of COPD at ATS 2015. According to Sunovion, the studies show that Brovana produces clinically significant improvement in health status compared to placebo, that only about half of COPD patients in hospital get long acting … [Read more...] about Sunovion announces results of Brovana studies
Boehringer Ingelheim presents new data analysis from tiotropium/olodaterol Respimat studies
Boehringer Ingelheim Pharmaceuticals has presented new data analyses from two Phase 3 studies of its tiotropium/olodaterol Respimat SMI for the treatment of COPD at ATS 2015. The two efficacy and safety studies (NCT01431274 and NCT01431287), compared a fixed dose tiotropium/olodaterol combination delivered by the Respimat inhaler to each of the individual components … [Read more...] about Boehringer Ingelheim presents new data analysis from tiotropium/olodaterol Respimat studies
Inhaled drug developer Serendex says that it is prepared for clinical trials
Danish inhaled drug developer Serendex has announced that it has met a number of milestones this year in preparation for clinical development of its portfolio. According to Serendex, in the first quarter of 2015, the company obtained a GMP certificate to allow it to manufacture its own clinical trial supplies and has initiated a Phase 1 clinical trial of its Molgradex … [Read more...] about Inhaled drug developer Serendex says that it is prepared for clinical trials
Prosonix to be acquired by Circassia Pharmaceuticals for up to £100 million
Inhaled drug developer Prosonix will be acquired by Circassia Pharmaceuticals for a total of £100 million in cash, the company said. Of that total, £70 million will be paid up front, with an additional £30 million "on the achievement of a near term milestone." In September 2014, Prosonix submitted an MAA for its PSX1001 generic fluticasone propionate MDI to the … [Read more...] about Prosonix to be acquired by Circassia Pharmaceuticals for up to £100 million
Discovery Labs announces results from Phase 2a trial of Aerosurf
Discovery Laboratories has announced that data from a Phase 2a clinical trial of Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants show that the novel delivery technology performed acceptably and that Aerosurf was safe and well tolerated. During the study, the effects of three escalating doses of the … [Read more...] about Discovery Labs announces results from Phase 2a trial of Aerosurf
JAMA Internal Medicine articles on the impact of the CFC to HFA transition criticize FDA and pharmaceutical companies
In a note accompanying a set of articles on the impact of the FDA's ban on the use of CFC propellants in metered dose inhalers and the transition to HFA inhalers, published online on May 11, 2015, the editors of JAMA Internal Medicine suggest that while any potential ecological benefits of the ban remain unclear, the benefits to the pharmaceutical industry are … [Read more...] about JAMA Internal Medicine articles on the impact of the CFC to HFA transition criticize FDA and pharmaceutical companies
Chiesi to commercialize Bronchitol in the UK, Ireland, and Germany
Pharmaxis has announced that beginning in June 2015, Chiesi Farmaceutici will take over the commercialization of the Bronchitol mannitol DPI for the treatment of cystic fibrosis in the UK, Ireland, and Germany. Additionally, Pharmaxis said that is ending its commercialization agreement with Quintiles, which was announced in 2011 and, for the time being, will … [Read more...] about Chiesi to commercialize Bronchitol in the UK, Ireland, and Germany