GSK and Theravance have announced results for two Phase 3 studies of its ICS/LABA combo DPI Relovair for the treatment of COPD. The product combines fluticasone furoate and vilanterol. The companies said that the studies demonstrated statistically significant change in 0-4 hour weighted mean FEV1 and trough FEV1 for patients treated with Relovair compared with … [Read more...] about Two Phase 3 studies of Relovair completed
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Aptar Classic modular pump chosen for Sprix nasal spray
Aptar Pharma is touting the use of its "Classic" modular spray pump in the recently launched Sprix ketorolac tromethamine nasal spray from Regency Therapeutics. Regency is a new division of Luitpold Pharmaceuticals, which acquired Sprix developer Roxro in December 2010. Aptar had worked with Roxro for 7 years on development of the product, and Eric Hohenschuh, … [Read more...] about Aptar Classic modular pump chosen for Sprix nasal spray
Generex licenses RapidMist technology
Generex Biotechnology has reached an agreement with Amarantus BioSciences regarding Generex's RapidMist buccal aerosol delivery system. The RapidMist device is a modified metered dose inhaler that delivers the aerosol to the lining of the mouth instead of to the lungs. Amarantus, which is paying Generex $10 million for use of the technology, will use it to deliver … [Read more...] about Generex licenses RapidMist technology
Rigel raises $130 million in stock offering
Rigel Pharmaceuticals has said that it is raising approximately $130.4 million as the result of a stock offering involving 16.3 million new shares. The company says that it expects the offer to close on or about June 1, 2011. Pfizer recently returned the rights to Rigel's inhaled syk inhibitor, R343. R343 is ready to move into Phase 2 trials, and the money raised … [Read more...] about Rigel raises $130 million in stock offering
MAP Pharmaceuticals submits NDA for Levadex
MAP Pharmaceuticals has submitted a new drug application (NDA) to the US FDA for its Levadex inhaled dihydroergotamine (DHE) for the treatment of migraines. The delivery device used for the product is the company's proprietary breath-activated MDI, the Tempo inhaler. MAP recently published data from its Phase 3 FREEDOM-301 trial, in which Levadex met all 4 primary … [Read more...] about MAP Pharmaceuticals submits NDA for Levadex
CHMP issues negative opinion on Pharmaxis’s Bronchitol
Members of the Committee for Medicinal Products for Human Use (CHMP) have indicated that they would vote against approval of Pharmaxis's marketing application for Bronchitol as a treatment for cystic fibrosis (CF). The CHMP took the trend vote after hearing an oral presentation by Pharmaxis regarding the application at its meeting last week. The official vote to … [Read more...] about CHMP issues negative opinion on Pharmaxis’s Bronchitol
OptiNose wins innovation award for nasal delivery technology
OptiNose has won the Oslo regional competition of the DnB NOR Innovation Award for its nasal drug delivery technology, and the company will compete in the Norwegian national competition in September. The regional award includes a prize of 200,000 NOK (~$36,000), and the national prize is 1 million NOK. The competition is sponsored by the Norwegian bank … [Read more...] about OptiNose wins innovation award for nasal delivery technology
Shortage of acetylcysteine inhalation solution
The FDA has announced a shortage of acetylcysteine inhalation solution in the US due to increased demand and manufacturing delays. Acetylcysteine is a mucolytic agent. According to the FDA web site, two manufacturers, Hospira and Roxanne Laboratories are experiencing shortages of 200 mg/ml vials as a result of increased demand and expect to release new product by … [Read more...] about Shortage of acetylcysteine inhalation solution
New Asian distributors for Freeman Technology powder rheometer
Freeman Technology has appointed two new distributors for its FT4 powder rheometer, a universal powder tester that provides data useful for .the optimization of dry powder formulations The new distributors are Aimil Ltd., which will distribute the FT4 in India, and DKSH, which will handle distribution in Singapore, Malaysia, Thailand, and Taiwan. Freeman … [Read more...] about New Asian distributors for Freeman Technology powder rheometer
Takeda confirms Nycomed acquisition
One day after issuing a denial (for the second time) regarding rumors of a deal for Nycomed, Takeda has confirmed its acquisition of the Swiss company for €9.6 billion (~$13.7 billion). The deal does not include Nycomed's US dermatology business, which will be spun off. Yasuchika Hasegawa, President & CEO of Takeda, said: “Takeda is committed to transforming our … [Read more...] about Takeda confirms Nycomed acquisition