Cipla has announced the launch of its Serroflo salmeterol/fluticasone MDI, a generic version of Advair, in Germany and Sweden. The inhaler will be available in 25/125 mcg and 25/250 mcg versions, both of which will have 120 doses. The Serroflo brand name will be used in Germany; in Sweden, the product will be called Salmeterol/Fluticasone Cipla.” The inhaler is … [Read more...] about Cipla launches salmeterol/fluticasone MDI in Germany and Sweden
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Civitas gets $55 million for Phase 3 development of inhaled L-dopa
Civitas Therapeutics has announced that all of its existing investors, plus seven new investors, participated in a $55 million Series C financing round. The company is developing products based on respiratory delivery technology acquired from Alkermes in 2011 and originally developed by AIR. Civitas President and CEO Mark Iwicki commented, “The proceeds from this … [Read more...] about Civitas gets $55 million for Phase 3 development of inhaled L-dopa
Fresenius Kabi launches acetylcysteine 10% solution
In addition to its 20% acetylcysteine solution products, Fresenius Kabi is now offering 4 ml, 10 ml, and 30 ml vials of acetylcysteine 10% for oral use or inhalation in the US. Acetylcysteine is a mucolytic used to thin mucous in the lungs of patients with conditions such as cystic fibrosis, bronchiectasis, and pneumonia. The drug was on the FDA's drug shortage list … [Read more...] about Fresenius Kabi launches acetylcysteine 10% solution
Skyepharma acquires Pulmagen inhalation technology
Skyepharma says that it will begin developing a COPD therapy based on Pulmagen's ICS "re-sensitization" technology (SKP-2075) by the end of 2014 after acquiring the IP and global rights to the Theocort platform from Pulmagen. According to Skyepharma, it plans to spend about £14 million to develop SKP-2075 through Phase 2 and then will seek to out-license the product. … [Read more...] about Skyepharma acquires Pulmagen inhalation technology
Insmed stock offering to support Arikayce development and commercialization
Insmed Incorporated is offering 8.9 million shares of common stock at $11.25 per share, with expected net proceeds of $94 million to go toward continued development of Arikayce liposomal amikacin for inhalation. The company recently announced that it plans to file an MAA for Arikayce for the treatment of refractory nontuberculous mycobacteria (NTM) lung infections and … [Read more...] about Insmed stock offering to support Arikayce development and commercialization
Sanofi partners with MannKind to commercialize Afrezza inhaled insulin
Sanofi will pay MannKind $150 million upfront and milestone payments of up to $775 million for an exclusive development and commercialization license for Afrezza insulin inhalation powder, the companies have announced. The companies will split profits and losses, with Sanofi's share being 65% and MannKind getting 35%. Afrezza, which was approved by the FDA in June … [Read more...] about Sanofi partners with MannKind to commercialize Afrezza inhaled insulin
Adasuve launched in Latin America
Alexza Pharmaceuticals partner Grupo Ferrer has launched its Adasuve loxapine inhalation powder in Guatemala, Alexza has announced. The approval in Guatemala is the first that Ferrer has obtained for Adasuve outside of Europe. Ferrer is responsible for regulatory and commercial activities related to Adasuve in the EU, Latin America and CIS countries. Ferrer Chief … [Read more...] about Adasuve launched in Latin America
Aegis Therapeutics offers license for intranasal diabetes treatment
Aegis Therapeutics has announced the availability of "an exclusive license to develop, commercialize, and sell its patented non-invasive exenatide metered nasal spray diabetes drug." Aegis's intranasal product would be the only non-injectable formulation of exenatide, a GLP-1 analog that is currently marketed as Byetta and Bydureon by AstraZeneca. The intranasal … [Read more...] about Aegis Therapeutics offers license for intranasal diabetes treatment
OptiNose raises funds for development of intranasal fluticasone
According to OptiNose, the company has completed a Series C-1 round of financing that will support development of its second product, OPN-375 intranasal fluticasone. The company, along with partner Avanir, submitted an NDA for its first product, AVP-825 intranasal sumatriptan for the treatment of migraine, in January 2014. According to the company, its … [Read more...] about OptiNose raises funds for development of intranasal fluticasone
Alexza announces plans for development of inhaled ropinirole
Alexza Pharmaceuticals has announced that it will develop Staccato versions of ropinirole, a dopamine agonist, for the treatment of restless leg system (AZ-008) and for the treatment of hypomobility during OFF episodes in Parkinson's disease (AZ-009). The Staccato system uses heat to aerosolize pure API for inhalation. The company said that it also plans to begin a … [Read more...] about Alexza announces plans for development of inhaled ropinirole