AstraZeneca has announced an agreement with Circassia Pharmaceuticals for development and commercialization of the Tudorza and Duaklir dry powder inhalers in the US. AstraZeneca will receive $50 million in Circassia ordinary shares and $100 million on approval of Duaklir in the US or June 30, 2019, whichever comes first. Circassia will have the option to acquire … [Read more...] about Circassia acquires rights to Tudorza and Duaklir DPIs in the US
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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
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
Hikma to market Orion’s budesonide/formoterol Easyhaler in the Middle East and North Africa
According to Hikma Pharmaceuticals, the company has signed a licensing and distribution agreement with Orion Corporation for marketing rights to a budesonide/formoterol Easyhaler DPI for the treatment of asthma and COPD throughout the Middle East and North Africa (MENA). Hikma Vice Chairman and CEO of MENA and Emerging Markets Mazen Darwazah commented, “We are … [Read more...] about Hikma to market Orion’s budesonide/formoterol Easyhaler in the Middle East and North Africa
Insmed announces new US patent for Arikayce inhaled amikacin
The United States Patent and Trademark Office (USPTO) has granted Insmed Incorporated US Patent Number 9,566,234, titled, "Systems for treating pulmonary infections," the company said. The patent's claims relate to the use of Insmed's Arikayce liposomal amikacin inhalation solution for the treatment of nontuberculous mycobacteria (NTM) and other pulmonary infections. … [Read more...] about Insmed announces new US patent for Arikayce inhaled amikacin
Penthrox methoxyflurane inhaler launched in France and Belgium
According to Medical Developments International (MVP), Mundipharma has launched the company's Penthrox methoxyflurane inhaler for or the treatment of moderate to severe pain in trauma patients in France and Belgium, triggering a milestone payment of $2.0 million to MVP. Mundipharma owns the rights to Penthrox in most of Europe outside of the UK and Ireland, where … [Read more...] about Penthrox methoxyflurane inhaler launched in France and Belgium
GSK launches OTC Flonase Sensimist fluticasone furoate nasal spray in US
GSK Consumer Healthcare has announced the US launch of Flonase Sensimist fluticasone furoate nasal spray for the once-daily treatment of seasonal and perennial allergy symptoms. The FDA approved Flonase Sensimist, an over-the-counter version of Veramyst, in August 2016. GSK has been marketing an OTC fluticasone propionate nasal spray as Flonase Allergy Relief in … [Read more...] about GSK launches OTC Flonase Sensimist fluticasone furoate nasal spray in US
Impel NeuroPharma announces agreement with Camargo Pharmaceutical Services
According to intranasal drug developer Impel NeuroPharma, the company has signed service agreements with 505(b)(2) development specialist Camargo Pharmaceutical Services. Camargo will provide development services for products based on Impel's Precision Olfactory Delivery (PODTM) intranasal delivery platform. In December 2016, Impel announced that it had raised up … [Read more...] about Impel NeuroPharma announces agreement with Camargo Pharmaceutical Services
MannKind launches Afrezza titration pack, expands sales force
MannKind Corporation has announced the availability of a new titration pack which includes 60 each of 4, 8, and 12 unit cartridges of Afrezza inhalation powder. The company already offers a titration pack that includes 90 each of 4 and 8 unit cartridges, which it says accounts for nearly 25% of Afrezza units dispensed on a weekly basis. According to the company, … [Read more...] about MannKind launches Afrezza titration pack, expands sales force