Pulmatrix has announced that a pilot bioequivalence study of 5 formulations of its PUR0200 DPI for the treatment of COPD has begun enrollment. The company is partnered with Mylan on development of the DPI. According to Pulmatrix, enrollment of 42 healthy volunteers for the study should be completed by the end of the first quarter of 2016, and results should be … [Read more...] about Pulmatrix bioequivalence study of PUR0200 gets underway
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Positive Phase 2a results for Mast’s AIR001 for the treatment of heart failure
Mast Therapeutics says that top-line results from a Phase 2a study of its AIR001 sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) demonstrated statistically significant change in pulmonary capillary wedge pressure (PCWP) during exercise compared to placebo, which was the primary endpoint. Mast acquired … [Read more...] about Positive Phase 2a results for Mast’s AIR001 for the treatment of heart failure
Avanir’s Onzetra Xsail intranasal sumatriptan approved by FDA
The FDA has approved Avanir Pharmaceuticals' intranasal sumatriptan for the treatment of acute migraines, the company said. The product, which Avanir licensed from OptiNose in 2013, will be marketed in the US as Onzetra Xsail. Avanir submitted an NDA for the product, then known as AVP-825, in January 2014 and received a complete response letter from the FDA in … [Read more...] about Avanir’s Onzetra Xsail intranasal sumatriptan approved by FDA
Mundipharma to market Flutiform in Central and South America, Mexico
Skyepharma has announced agreements with Sanofi and Mundipharma that will transfer Mexican, Central American, and South American development, licensing and marketing rights for the Flutiform fluticasone/formoterol MDI to Mundipharma. Sanofi will continue to manufacture Flutiform at its Holmes Chapel, UK facility. Sanofi licensed those rights from Skyepharma in 2011 … [Read more...] about Mundipharma to market Flutiform in Central and South America, Mexico
Milestone’s intranasal calcium channel antagonist gets generic name “etripamil”
Milestone Pharmaceuticals has announced today that its MSP-2017 intranasal calcium channel antagonist has been assigned the unique non-proprietary name "etripamil" by the United States Adopted Name (USAN) Council. The company is developing the etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone CEO Philippe Douville … [Read more...] about Milestone’s intranasal calcium channel antagonist gets generic name “etripamil”
Mucosis gets €3.7 million grant for development of intranasal RSV vaccine
Dutch intranasal vaccine developer Mucosis has received €3.7 million from the Wellcome Trust for clinical development of its SynGEM intranasal respiratory syncytial virus (RSV) vaccine, the company said. The money will be used to fund a Phase 1 dose-finding study and a Phase 2 challenge study conducted by researchers from the National Heart & Lung Institute, Imperial … [Read more...] about Mucosis gets €3.7 million grant for development of intranasal RSV vaccine
MannKind announces deal with newly formed company
MannKind Corporation has announced an agreement to develop "multiple inhaled therapeutic products" with a company called Receptor Life Sciences, described as a "newly formed entity." MannKind says that Receptor will license MannKind's manufacturing technology and will be responsible for manufacturing and commercialization of the products as well as all development … [Read more...] about MannKind announces deal with newly formed company
Neurelis announces initiation of pivotal trials for intranasal diazepam
Neurelis says that it has received guidance from the FDA regarding clinical trial requirements for the company's NRL-1 intranasal diazepam for the treatment of acute repetitive seizures in epilepsy patients and is now initiating the pivotal trial program for the product. Neurelis President and CEO Craig C. Chambliss commented, "We were pleased to obtain guidance … [Read more...] about Neurelis announces initiation of pivotal trials for intranasal diazepam
Turing says that it is initiating Phase 1 clinical trials for intranasal ketamine
Turing Pharmaceuticals said that it has received a no objection letter from Health Canada regarding the initiation of Phase 1 trials of TUR-002 intranasal ketamine for the reduction of suicidal ideations and that it expects to complete the trials by mid-2016. The timing is in line with a November 2015 announcement from Turing that was made prior to the arrest and … [Read more...] about Turing says that it is initiating Phase 1 clinical trials for intranasal ketamine
Health Canada approves Natesto nasal testosterone gel
Acerus Pharmaceuticals has received approval from Health Canada to market Natesto nasal gel as a testosterone replacement therapy in adult males with hypogonadism, and the product should be available in Canada by mid-2016, the company said. Acerus President and CEO Tom Rossi said, “Natesto addresses many of the gaps with current testosterone replacement therapies. … [Read more...] about Health Canada approves Natesto nasal testosterone gel