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Teva has announced that the UK High Court has invalidated AstraZeneca's patent titled "Use of a composition comprising formoterol and budesonide for the prevention or treatment of an acute condition of asthma" (EP 1,085,877), which covers the SMART (Single inhaler Maintenance And Reliever Therapy) indication for Symbicort. The company says that it sought to invalidate … [Read more...] about UK court rules against AstraZeneca on Symbicort patent challenge

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

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

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 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 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 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

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 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