GSK and Innoviva have announced that the EMA accepted a regulatory submission to expand the use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI to add the treatment of asthma in adults as an indication. Trelegy Ellipta has been approved in Europe for the treatment of COPD since November 2017. A previous Type II variation application was approved in … [Read more...] about EMA accepts GSK submission to expand use of Trelegy Ellipta to asthma
News
Otitopic announces planned PK/PD study of its Asprihale aspirin DPI
Otitopic announced that it has held discussions with the FDA regarding a pivotal PK/PD study of its Asprihale aspirin dry powder inhaler and now expects to initiate the study in the fourth quarter of 2020. Results are expected by the end of 2021, the company said. Otitopic is developing Asprihale for the treatment of myocardial infarction and has indicated that it … [Read more...] about Otitopic announces planned PK/PD study of its Asprihale aspirin DPI
FDA approves Perrigo’s generic version of Teva’s ProAir albuterol MDI (updated)
The FDA has announced the approval of Perrigo's ANDA for a generic of Teva's ProAir HFA albuterol MDI for the treatment of asthma in patients 4 years old and older. Perrigo initially filed its ANDA for the generic version of ProAir HFA in 2012; Teva responded with a patent infringement suit. In 2014, the companies reached a settlement that would give Perrigo … [Read more...] about FDA approves Perrigo’s generic version of Teva’s ProAir albuterol MDI (updated)
Phase 3 trial of Tyvaso inhaled treprostinil in patients with PH-ILD meets primary endpoint
United Therapeutics has announced that the Phase 3 INCREASE study of Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary endpoint, demonstrating statistically significant improvement in six-minute walk distance (6MWD). All secondary endpoints for the study were also … [Read more...] about Phase 3 trial of Tyvaso inhaled treprostinil in patients with PH-ILD meets primary endpoint
Teva’s ArmonAir Digihaler approved by the FDA
The FDA has approved Teva's ArmonAir Digihaler fluticasone propionate DPI for the treatment of asthma in patients aged 12 and older, the company said. ArmonAir Respiclick was approved for that indication in January 2017. Three doses were approved for twice daily inhalation: 55 mcg, 113 mcg and 232 mcg. The Digihaler device includes a built-in usage monitoring … [Read more...] about Teva’s ArmonAir Digihaler approved by the FDA
Grifols agrees to acquire all assets related to Aradigm’s inhaled ciprofloxacin programs
Aradigm Corporation, which filed for bankruptcy in February 2019, said that it will sell all of its assets related to Lipoquin inhaled ciprofloxacin, Apulmiq (Linhaliq) dual release inhaled ciprofloxacin, and other inhaled ciprofloxacin candidates to Grifols, subject to approval by the bankruptcy court. The deal also leaves Aradigm "free to accept higher and better … [Read more...] about Grifols agrees to acquire all assets related to Aradigm’s inhaled ciprofloxacin programs
Nanopharm adds to management team
Nanopharm CEO Jag Shur has announced the addition of three new members of the company's management team in a LinkedIn post. The new hires include two OINDP experts: Dave Farrow, who joins the company as Director of Operations, and Chris Vernall as Director of Business Development. Farrow was most recently Head of Development at Albany Molecular Research, Inc. and … [Read more...] about Nanopharm adds to management team
Breath Therapeutics initiates additional studies of inhaled liposomal cyclosporine A for bronchiolitis obliterans
Breath Therapeutics, which was acquired by Zambon in July 2019, said that it has initiated two new trials of its liposomal cyclosporine A for inhalation (L-CsA-i) for the treatment of bronchiolitis obliterans syndrome (BOS). BOSTON-3 is open-label extension study of the Phase 3 BOSTON-1 and BOSTON-2 studies of L-CsA-i for the treatment of BOS after a lung transplant … [Read more...] about Breath Therapeutics initiates additional studies of inhaled liposomal cyclosporine A for bronchiolitis obliterans
RDD returns to California for RDD 2020
OINDP experts will gather once again in Palm Desert, California from April 26-30 for the 2020 edition of the Respiratory Drug Delivery (RDD) conference. As with past RDD meetings, attendees will find a scientific program and poster exhibition featuring the latest in aerosol drug delivery science, a technology exhibition with companies offering products and services, … [Read more...] about RDD returns to California for RDD 2020
Copley Scientific introduces new inhaled dissolution dose collector
Copley Scientific has announced the launch of a new inhaled dissolution dose collector (IDDC) system for the collection of representative samples of particles from MDIs and DPIs for dissolution testing by USP Method 2. The system can collect the impactor sized mass or the fine particle dose, depending on the inlet used. According to Copley, the IDDC works with … [Read more...] about Copley Scientific introduces new inhaled dissolution dose collector