The FDA has approved an updated nebulizer for use with United Therapeutics' Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension, the company said. The new TD-300/A device will be launched next year. According to United Therapeutics, the TD-300/A nebulizer "has a cleaner, more ergonomic design that includes single button … [Read more...] about FDA approves new device for use with Tyvaso inhalation solution
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Evoke announces positive results for Gimoti metoclopramide nasal spray PK study
Evoke Pharma says that a comparative exposure PK study has shown that 2 out of 3 doses of its Gimoti metoclopramide nasal spray demonstrated bioequivalence to oral metoclopramide and, based on those results, the company plans to submit a 505(b)(2) NDA for Gimoti early in 2018. Evoke is developing Gimoti for the treatment of diabetic gastroparesis. In December … [Read more...] about Evoke announces positive results for Gimoti metoclopramide nasal spray PK study
Sunovion launches Seebri Neohaler in the US
Sunovion has announced the US launch of Seebri Neohaler glycopyrrolate DPI for the treatment of COPD. Seebri Neohaler was approved by the FDA in October 2015. Sunovion acquired US rights to Seebri Neohaler, along with the Arcapta indacaterol and Utibron indacaterol/glycopyrrolate Neohalers, from Novartis in December 2016. Seebri Neohaler is known as Seebri … [Read more...] about Sunovion launches Seebri Neohaler in the US
Spyryx Biosciences initiates Phase 2 study of SPX-101 for cystic fibrosis
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
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