Pulmatrix said that based on final results from a Phase 1/1b study of its Pulmazole (PUR1900) itraconazole DPI, which it is developing for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients, the company now plans to begin a Phase 2 trial by the end of the year. The company previously reported top line data from the study showing … [Read more...] about Pulmatrix announces plans for Phase 2 study of Pulmazole itraconazole DPI
News
H&T Presspart wins GSK Challenge “Most Impact on Healthcare Community” Award
Device maker H&T Presspart has announced that its eMDI connected inhaler technology won the award for "Most Impact on Healthcare Community" in the GlaxoSmithKline (GSK) Challenge at the 2018 Active and Intelligent Packaging Industry Association (AIPIA) World Congress. Benjamin Jung and Jan Henke of H&T Presspart made the winning presentation. The company said, "We … [Read more...] about H&T Presspart wins GSK Challenge “Most Impact on Healthcare Community” Award
Astech Projects to launch Blister Strip Recovery Workstation at DDL 2018
Automated inhaler testing specialist Astech Projects has announced that it will launch its new Blister Strip Recovery Workstation at the upcoming DDL 2018 meeting. The company will be exhibiting the workstation, which automatically pierces and washes DPI blister pockets for preparation of analytical samples using an automatically controlled metering pump. The … [Read more...] about Astech Projects to launch Blister Strip Recovery Workstation at DDL 2018
FDA approves Lupin budesonide inhalation suspension
According to Lupin, the FDA has approved its ANDA 0.5 mg/2 mL single dose ampules of budesonide inhalation suspension, a generic version of AstraZeneca's Pulmicort Respules, for the treatment of asthma in children aged 12 months to 8 years. Other companies with approved ANDAs for budesonide inhalation suspension 0.5 mg/2 mL include Apotex (licensed to Nephron), … [Read more...] about FDA approves Lupin budesonide inhalation suspension
FDA approves Yupelri revefenacin inhalation solution for COPD
According to Theravance Biopharma and Mylan, the FDA has approved the NDA for Yupelri revefenacin inhalation solution for the treatment of COPD. The NDA was submitted in November 2017, and the FDA accepted the application for review in January 2018. The two companies announced in 2015 that they would partner to develop revefenacin, then known as TD-4208, as an … [Read more...] about FDA approves Yupelri revefenacin inhalation solution for COPD
InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide
InCarda Therapeutics has announced the completion of an oversubscribed $42 million Series B financing that will fund a Phase 2 study of InRhythm inhaled flecainide for the treatment of recent-onset paroxysmal atrial fibrillation (PAF). The financing round was led by Sofinnova and HealthCap, both new investors along with Deerfield Management. In 2015, InCarda raised … [Read more...] about InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide
Trelegy Ellipta gets expanded indication for COPD in Europe
According to GlaxoSmithKline and Innoviva, the European Commission has approved a label change for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, extending its use to patients with moderate to severe COPD who do not achieve adequate relief of symptoms with a dual bronchodilator. Trelegy Ellipta was approved in Europe in 2017 for COPD patients not … [Read more...] about Trelegy Ellipta gets expanded indication for COPD in Europe
Flutiform okayed for pediatric use in Europe
Mundipharma has announced that its license variation application to extend the use of the Flutiform fluticasone propionate/formoterol MDI to asthma patients aged 5 up to 12 years for whom an ICS/LABA combination is appropriate has received a positive opinion. Flutiform has been approved in Europe for the treatment of asthma in patients 12 and older since 2012. The … [Read more...] about Flutiform okayed for pediatric use in Europe
Insmed CEO Will Lewis becomes chairman of the board as Donald Hayden, Jr steps down
Insmed Incorporated has announced that its Chairman of the Board Donald Hayden, Jr is stepping down as chairman and will be replaced by Insmed President and CEO Will Lewis. Hayden, who served as chairman for 13 years, will continue as a director. Former AstraZeneca CEO David Brennan has been elected as lead independent director. In addition, former Johnson & … [Read more...] about Insmed CEO Will Lewis becomes chairman of the board as Donald Hayden, Jr steps down
FDA approves OTC Primatene Mist for mild asthma
Eight years after being phased out at the end of 2011 due to its CFC propellant, Amphastar Pharmaceuticals' Primatene Mist epinephrine MDI has been reinstated by the FDA as the only asthma inhaler approved for over the counter sales in the US. The approval is limited to the temporary relief of mild, intermittent asthma symptoms in people aged 12 and over. The new … [Read more...] about FDA approves OTC Primatene Mist for mild asthma