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)
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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
Cipla to launch salmeterol/fluticasone MDI in Czech Republic, Slovakia
Cipla has announced that it has entered into a distribution agreement with S&D Pharma in the Czech Republic and Slovakia in which S&D will distribute Cipla products. The deal includes distribution "in the near future, once the necessary regulatory and reimbursement approvals are in place," of two dosages of salmeterol/fluticasone, 25/125 mcg and 25/250 mcg, with the … [Read more...] about Cipla to launch salmeterol/fluticasone MDI in Czech Republic, Slovakia
Pfizer to market Ultibro Breezhaler and Seebri Breezhaler in the UK
Pfizer UK has announced that it has signed an exclusive agreement with Novartis to market the Ultibro Breezhaler indacaterol/glycopyrronium DPI and the Seebri Breezhaler glycopyrronium DPI in the UK for the treatment of COPD. Seebri Breezhaler was approved in Europe in October 2012 and has been available in the UK since November of that year. Ultibro Breezhaler … [Read more...] about Pfizer to market Ultibro Breezhaler and Seebri Breezhaler in the UK
Propeller Health raises $14.5 million
Inhaler monitoring company Propeller Health (formerly Asthmapolis) has announced that it raised $14.5 million in a Series B financing round led by Safeguard Scientifics. Safeguard Managing Director Gary J. Kurtzman will join Propeller Health's board of directors. Propeller also announced that it has hired Chris Hogg, formerly CEO of mobile health company 100Plus, as … [Read more...] about Propeller Health raises $14.5 million
Aradigm gets fast track designation for Pulmaquin
The FDA has granted fast track designation to Aradigm's Pulmaquin dual release inhaled ciprofloxacin for treatment of chronic Pseudomonas aeruginosa lung infections in non-cystic fibrosis bronchiectasis patients, the company said. Aradigm initiated a second Phase 3 trial of Pulmaquin for that indication in June 2014. The product received Qualified Infection Disease … [Read more...] about Aradigm gets fast track designation for Pulmaquin
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.
Freeman Technology establishes office in China
Powder characterization specialists Freeman Technology have announced the opening of an office in Shanghai and the appointment of Joey Xie as Product Manager and Chief Representative in China. The company added that it has also recently entered into a distribution partnership for its FT4 powder rheometer with Research Instruments in Malaysia and Singapore and with … [Read more...] about Freeman Technology establishes office in China
UK court rules against AstraZeneca on Symbicort patent challenge
Teva has announced that the UK High Court has invalidated AstraZeneca's patent titled "Use of a composition comprising formoterol and budesonide for the prevention or treatment of an acute condition of asthma" (EP 1,085,877), which covers the SMART (Single inhaler Maintenance And Reliever Therapy) indication for Symbicort. The company says that it sought to invalidate … [Read more...] about UK court rules against AstraZeneca on Symbicort patent challenge
Cipla launches salmeterol/fluticasone MDI in Germany and Sweden
Cipla has announced the launch of its Serroflo salmeterol/fluticasone MDI, a generic version of Advair, in Germany and Sweden. The inhaler will be available in 25/125 mcg and 25/250 mcg versions, both of which will have 120 doses. The Serroflo brand name will be used in Germany; in Sweden, the product will be called Salmeterol/Fluticasone Cipla.” The inhaler is … [Read more...] about Cipla launches salmeterol/fluticasone MDI in Germany and Sweden