Discovery Laboratories, which recently released positive Phase 2a data for its Aerosurf aerosolized KL4 surfactant and advanced the product into Phase 2b, has announced the appointment of Craig Fraser as President and CEO. Fraser was most recently Chief Operating Officer of Aegerion Pharmaceuticals and previously held positions at Pfizer, Wyeth, and Johnson & Johnson. … [Read more...] about Discovery Labs appoints Craig Fraser as President and CEO, provides update on Aerosurf program
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OptiNose selected for Norwegian grant to study intranasal narcolepsy therapy
OptiNose has been selected by the Research Council of Norway for a grant of up to NOK 15.9 million ($1.8 million) to study intranasal delivery of Orexin-A for the treatment of narcolepsy. The grant is contingent on reaching a contract agreement between the Research Council, OptiNose, and its partners, which include Oslo University Hospital, Smerud Medical Research, … [Read more...] about OptiNose selected for Norwegian grant to study intranasal narcolepsy therapy
Pulmatrix bioequivalence study of PUR0200 gets underway
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
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