Intranasal drug developer Impel NeuroPharma has announced the appointment of former MAP Pharmaceuticals President and CEO Timothy S. Nelson as Independent Director of the Board of Directors. Nelson led MAP Pharmaceuticals when it was acquired by Allergan and served as Chairman of the Board of Civitas Therapeutics when that company was acquired by Acorda. MAP … [Read more...] about Timothy S. Nelson joins the board of Impel NeuroPharma
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Copley Scientific introduces updated sample preparation unit for inhaler testing
Copley Scientific has introduced a modified induction port fixture on its sample preparation unit (SPU) Model 2000, the company said. The modification allows for the use of a fluticasone propionate/salmeterol xinafoate (FP/SX) induction port in addition to NGI and ACI induction ports. Copley Scientific Sales Director Mark Copley commented, “Fully automating cascade … [Read more...] about Copley Scientific introduces updated sample preparation unit for inhaler testing
Larry Mallis joins Lovelace Biomedical as Director of Bioanalytical Operations
Lovelace Biomedical, a not-for-profit research organization which offers inhalation toxicology and other services for inhaled drug development, has announced the appointment of Larry Mallis as Director of Bioanalytical Operations. Mallis was most recently Director of Bioanalytical Services as Frontage Laboratories and was previously Director of Scientific Services … [Read more...] about Larry Mallis joins Lovelace Biomedical as Director of Bioanalytical Operations
GSK says study shows Relvar (Breo) Ellipta non-inferior to Seretide (Advair) for well-controlled asthma
GlaxoSmithKline has announced that a lung function study to demonstrate non-inferiority for once-daily use of the Relvar (Breo) Ellipta fluticasone furoate/vilanterol DPI compared to twice-daily Seretide (Advair) fluticasone propionate/salmeterol DPI in patients with well-controlled asthma met its primary endpoint. In 2013, Relvar Ellipta was approved by the EU … [Read more...] about GSK says study shows Relvar (Breo) Ellipta non-inferior to Seretide (Advair) for well-controlled asthma
Pharmaxis announces completion of treatment in Phase 3 trial of Bronchitol for CF
According to Pharmaxis, treatment has been concluded in a Phase 3 trial of its Bronchitol mannitol DPI for the treatment of cystic fibrosis. A total of 423 patients in 21 countries were treated in the 26-week randomized, double-blind parallel group study. The company expects to report topline results in the second quarter of 2017 and, if results are positive, to … [Read more...] about Pharmaxis announces completion of treatment in Phase 3 trial of Bronchitol for CF
Adapt files MAA for its naloxone nasal spray, Amphastar gets CRL for its version
Adapt Pharma has filed a marketing authorization application in Europe for its naloxone nasal spray for the treatment of opioid overdose, the company said. Adapt's naloxone nasal spray, marketed as Narcan, has been approved in the US since 2015 and in Canada since 2016. The FDA also approved a lower dose of formulation of Narcan in January 2017. Meanwhile, … [Read more...] about Adapt files MAA for its naloxone nasal spray, Amphastar gets CRL for its version
RDD Europe returns to Antibes
For RDD Europe 2017, to be held April 25-28, 2017 at the Palais des Congrès in Antibes, France, organizers RDD Online and Aptar Pharma expect approximately 450 OINDP experts to attend the 3-day conference. Two years ago, the 10th anniversary edition of RDD Europe, which was also held in Antibes, attracted 440 delegates from 31 countries. RDD Online's Richard Dalby … [Read more...] about RDD Europe returns to Antibes
Vectura announces that it met royalty cap on Ellipta products a year earlier than expected
Vectura met the £9 million calendar year royalty cap on GSK's Ellipta DPI products in 2016, a year earlier than predicted, the company said. The £9 million calendar year royalty cap is included in a legacy Skyepharma/GSK agreement that pays Vectura low single-digit royalties on net sales of Ellipta dry powder inhaler products. The company said that it will record … [Read more...] about Vectura announces that it met royalty cap on Ellipta products a year earlier than expected
Dauntless Pharmaceuticals initiates Phase 1 study of intranasal octreotide
Dauntless Pharmaceuticals has initiated a Phase 1 clinical study of its DP1038 intranasal octreotide acetate, the company said. The study will compare DP1038 to Sandostatin octreotide acetate injection in healthy volunteers. DP1038 is in development for the treatment of acromegaly and neuroendocrine tumors. In July 2014, Aegis Therapeutics announced that it was … [Read more...] about Dauntless Pharmaceuticals initiates Phase 1 study of intranasal octreotide
Windtree says aerosolized KL4 surfactant shows promise for treatment of flu in pre-clinical study
Windtree Therapeutics says a pre-clinical study in ferrets exposed to influenza demonstrated that the company's aerosolized KL4 surfactant increased survival and reduced lung inflammation, although the increase in survival rate was less than that for animals treated with oseltamivir (Tamiflu). Fewer clinical signs of influenza were observed in animals treated with KL4 … [Read more...] about Windtree says aerosolized KL4 surfactant shows promise for treatment of flu in pre-clinical study