NovaBiotics has announced that its Lynovex (NM001) cysteamine for the treatment of cystic fibrosis has been granted orphan drug designation by the FDA. NovaBiotics is developing both oral and dry powder inhalation formulations of the drug which, according to the company, breaks down mucus and prevents formation of biofilms in the lungs of CF patients. A Phase 2a … [Read more...] about NovaBiotics’ Lynovex for CF gets US orphan drug designation
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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
Galen to market Penthrox inhaled methoxyflurane in the UK and Ireland
Almac subsidiary Galen Ltd will pay Medical Developments International (MVP) approximately A$650,000 (~US$587,000) up front for a license to market and distribute MVP's Penthrox inhaled methoxyflurane in the UK and Ireland. The deal also includes undisclosed regulatory and sales milestone payments. Penthrox, a non-opioid analgesic delivered via a proprietary vapor … [Read more...] about Galen to market Penthrox inhaled methoxyflurane in the UK and Ireland
Voke nicotine inhaler approved in the UK
According to Kind Consumer, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the company's Voke nicotine inhaler for general sale. The company said that the license is "for use to relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence." Kind Consumer Chief Medical Officer Chris Moyses … [Read more...] about Voke nicotine inhaler approved in the UK
Verona says that it can fund studies of RPL554 up to Phase 2b
In its most recent interim report, Verona Pharma says that it raised over £14 million pounds earlier this year which will allow it to continue development of its RPL554, an inhaled PDE3/PDE4 inhibitor, for the treatment of asthma and COPD. The company says that it is developing a new "commercially scalable" nebulized formulation of the drug. Previous testing has … [Read more...] about Verona says that it can fund studies of RPL554 up to Phase 2b
Study shows potential of Prosonix multi-component particle technology
Prosonix has announced that a consortium of inhaled medicine and respiratory disease researchers with funding from the Biomedical Catalyst "has confirmed the potential of its Multi-component Particle (MCP) Technology for creating novel inhaled, dual and triple fixed dose combination (FDC) therapies for respiratory diseases." The research project included in vitro … [Read more...] about Study shows potential of Prosonix multi-component particle technology
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