Spyryx Biosciences has announced the initiation of the Phase 2 HOPE-1 study of SPX-101, an inhaled SPLUNC1-derived peptide, in cystic fibrosis patients. The 28-day study is designed to enroll as many as 78 CF patients and will compare two doses of SPX-101 against a placebo. In June 2017, Spyryx announced an increase in an award from Cystic Fibrosis Foundation … [Read more...] about Spyryx Biosciences initiates Phase 2 study of SPX-101 for cystic fibrosis
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Amneal and Impax announce merger agreement
Amneal Pharmaceuticals and Impax Laboratories have announced that the companies will merge, with the new company to be called Amneal Pharmaceuticals, Inc. The merger is expected to be complete by mid-2018. OINDPs marketed by Amneal include generic versions of TOBI inhalation solution and Astelin and Nasonex nasal sprays. Impax acquired US rights to Zolmig … [Read more...] about Amneal and Impax announce merger agreement
Aegis Therapeutics announces availability of intranasal hydromorphone formulation
Aegis Therapeutics says that it has developed an intranasal hydromorphone for the treatment of acute pain and is making the formulation available for license. According to the company, the formulation, which is based on the Intravail absorption enhancement technology, has demonstrated rapid onset and a Tmax of 7.5 minutes. A patent application filed by Aegis in … [Read more...] about Aegis Therapeutics announces availability of intranasal hydromorphone formulation
H&T Presspart gets European patent for eMDI
Device manufacturer H&T Presspart has received its first European patent for the eMDI connected metered dose inhaler, the company said. The eMDI contains sensors that record inhaler usage and transmits data to Cohero Health’s BreatheSmart inhaler tracking and lung function measurement platform via Bluetooth. The European patent covers the method used by the eMDI … [Read more...] about H&T Presspart gets European patent for eMDI
Real world study of Stiolto Respimat vs LAMA/LABA/ICS gets underway
Boehringer Ingelheim, insurer Anthem, and Anthem's research subsidiary HealthCore have announced the initiation of the AIRWISE study, which will compare Stiolto Respimat tiotropium bromide/olodaterol SMI to any commercially available combination of LAMA, LABA, and ICS for the reduction of COPD exacerbations in a real world setting. Results are expected in 2020. The … [Read more...] about Real world study of Stiolto Respimat vs LAMA/LABA/ICS gets underway
Flutiform k-haler for the treatment of asthma gets European approval
According to Mundipharma, the Flutiform fluticasone propionate/formoterol fumarate k-haler breath-activated MDI has received marketing approval through the European decentralized procedure for the treatment of asthma in patients 12 and older. The company had submitted the MAA in March 2016. Flutiform k-haler delivers the same dosages as the existing Flutiform MDI, … [Read more...] about Flutiform k-haler for the treatment of asthma gets European approval
Copley Scientific launches TPK 2100 critical flow controller for DPI testing
Inhaler test equipment manufacturer Copley Scientific has launched The TPK 2100, a new model in its TPK series of critical flow controllers for the testing of dry powder inhalers. The company is also launching a new TPK 2100-R with reversed flow inlet and outlets for alternative testing equipment set-ups. The TPK 2100 model's upgrades include a "fly-by-wire" flow … [Read more...] about Copley Scientific launches TPK 2100 critical flow controller for DPI testing
Scammers targeting DDL2017 conference delegates
DDL2017 delegates are being targeted by scammers, organizers warn. Callers claiming to be from the DDL organization have been phoning delegates and offering to book accommodations for the conference and then ask for credit card information. Anyone who has provided credit or debit card details to one of these callers should contact their bank … [Read more...] about Scammers targeting DDL2017 conference delegates
Pulmatrix’s PUR1900 gets additional QIDP designation
Pulmatrix has announced that its PUR1900 itraconazole DPI has received Qualified Infectious Disease Product (QIDP) designation for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. PUR1900 received Orphan Drug designation in 2016 and QIDP status in January 2017 for the treatment of ABPA in cystic fibrosis patients. In September … [Read more...] about Pulmatrix’s PUR1900 gets additional QIDP designation
Impel NeuroPharma appoints Jon Congleton as President and CEO
Intranasal drug developer Impel NeuroPharma has announced the appointment of former Nivalis Therapeutics leader Jon Congleton as the company’s new President and Chief Executive Officer (CEO). Congleton was most recently President and CEO of Nivalis and had previously served in a number of executive roles at Teva. He succeeds an interim CEO, co-Founder John Hoekman, … [Read more...] about Impel NeuroPharma appoints Jon Congleton as President and CEO