The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Anoro umeclidinium/vilanterol for the treatment of COPD, GlaxoSmithKline and Theravance have announced. The dosage would be 55 mcg/22 mcg UMEC/VI, delivered by the Ellipta DPI. Anoro Ellipta was approved in the US in December 2013 and in Canada in … [Read more...] about CHMP issues positive opinion for Anoro
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CURx Pharmaceuticals licenses Fosfomycin/Tobramycin for Inhalation from Gilead
Sad Diego-based CURx Pharmaceuticals has announced a global license agreement with Gilead Sciences for development of Fosfomycin/Tobramycin for Inhalation (FTI) to treat Pseudomonas aeruginosa lung infection in cystic fibrosis (CF) patients. Gilead initiated a Phase 2 study of the product, then known as GS 9310/11 in late 2008, and CURx says that FTI is ready for … [Read more...] about CURx Pharmaceuticals licenses Fosfomycin/Tobramycin for Inhalation from Gilead
Insmed provides update on ongoing study of Arikace for P. aeruginosa infections in CF patients
Insmed says that it is pleased with results from its ongoing CLEAR-110 extension study of Arikace inhaled liposomal amikacin for the treatment of P. aeruginosa infections in cystic fibrosis patients. Data from 98 patients who completed the first year of the two-year study showed that Arikace was well tolerated, the company said, and patients experienced continued … [Read more...] about Insmed provides update on ongoing study of Arikace for P. aeruginosa infections in CF patients
Maurice Chagnaud to develop Lupin’s inhalation strategy
Lupin Pharmaceuticals has announced that Maurice Chagnaud has joined the company as President, Europe and Head of Inhalation Strategy. He was most recently Senior Vice President, Central & Eastern Europe at Teva. Chagnaud's responsibilities will include Lupin's European business as well as the company's "core strategy for inhalation in the developed markets." Lupin … [Read more...] about Maurice Chagnaud to develop Lupin’s inhalation strategy
Actavis to acquire Forest Laboratories
Actavis will acquire Forest Laboratories in a deal worth approximately $25 billion, the companies have announced. Both boards of directors have approved the agreement. Forest's products include the Tudorza Pressair aclidinium bromide DPI, which launched in the US in December 2012. Last month, Forest announced its acquisition of Aptalis, the developer of Aeroquin … [Read more...] about Actavis to acquire Forest Laboratories
Another recall of acetylcysteine inhalation solution
Ben Venue Laboratories has voluntarily recalled a single lot of 30 ml vials of acetylcysteine 10% inhalation solution due to a glass particle visible in one of the vials. The recall affects lot #2005479 which has an expiration date of March 2014. According to Ben Venue, "There have been no complaints or adverse events related to a piece of glass in vials of this … [Read more...] about Another recall of acetylcysteine inhalation solution
AirFluSal Forspiro approved in additional countries
Sandoz has recently announced the approval of the AirFluSal Forspiro salmeterol/fluticasone DPI by Norway and Bulgaria, bringing the total number of European approvals to 7. The inhaler has also been approved in Denmark, Germany, Sweden, Hungary, and Romania. The Norwegian approval is for the 50/250 µg and 50/500 µg dosages for the treatment of asthma and for … [Read more...] about AirFluSal Forspiro approved in additional countries
Arikace to get orphan drug designation from EU
Insmed has announced that the EMA's Committee for Orphan Medicinal Products has issued a positive opinion regarding orphan designation for Insmed's Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The company says that it plans to report top line results from a Phase 2 trial of Arikace for NTM lung disease by the … [Read more...] about Arikace to get orphan drug designation from EU
Mast Therapeutics to acquire Aires Pharmaceuticals
Mast Therapeutics has announced that it will acquire Aires Pharmaceuticals, which is developing a sodium nitrite inhalation solution for the treatment of pulmonary arterial hypertension. The inhalation solution, known as AIR001 or "Aironite," has received orphan drug status from both the FDA and the EMA. Mast CEO Brian M. Culley commented, "The acquisition of … [Read more...] about Mast Therapeutics to acquire Aires Pharmaceuticals
Flutiform launched in France
Skyepharma has announced the launch of Flutiform fluticasone/formoterol MDI for the treatment of asthma in France. Mundipharma will market the inhaler in 50/5 µg and 125/5 µg versions. The launch triggers a €3.0 million milestone payment from Mundipharma to Skyepharma. Flutiform was approved by the European Commission in 2012 and has now been launched in 14 … [Read more...] about Flutiform launched in France