Savara Pharmaceuticals has announced positive top-line results from a Phase 1 study of its AeroVanc inhaled dry powder formulation of vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in patients with cystic fibrosis. According to the company, the study demonstrated that AeroVanc was well tolerated, that clearance of the … [Read more...] about Savara announces Phase I study results for AeroVanc, funding for Phase 2
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Pharmaxis submits NDA for Bronchitol, issues update on commercialization in Europe
Pharmaxis has submitted an NDA for Bronchitol inhaled dry powder mannitol for the treatment of cystic fibrosis to the FDA. Pharmaxis CEO Dr Alan Robertson said, “The submission marks the second of two key milestones for the Bronchitol program following approval last month to market the product in Europe. Cystic fibrosis patients have a life‐limiting disease. It … [Read more...] about Pharmaxis submits NDA for Bronchitol, issues update on commercialization in Europe
Insmed to defer Phase 3 study of Arikace in US
According to Insmed, the company has decided to focus on European and Canadian studies of its Arikace liposomal amikacin for inhalation and to put a US Phase 3 study on the back burner. The CLEAR-108 (CLinical Evaluation of ARikace) Phase 3 study of Arikace for the treatment of patients with cystic fibrosis is already underway in Europe and Canada, and Insmed says … [Read more...] about Insmed to defer Phase 3 study of Arikace in US
TOBI Podhaler wins Medical Design Excellence Award
The TOBI Podhaler has been named a bronze winner in the General Hospital Devices and Therapeutics Products division of the Medical Design Excellence Awards presented by UBM Canon and MD+DI. The inhaler, which is marketed by Novartis, was designed by Cambridge Consultants, and Gerresheimer Medical Plastic Systems gets the supply credit. The Sun Pharma Combitide … [Read more...] about TOBI Podhaler wins Medical Design Excellence Award
Mylan and Sunovion settle Brovana patent infringement suit
Mylan has announced that its subsidiary Mylan Specialty (formerly Dey Pharma) has reached an agreement with Sunovion Pharmaceuticals (formerly Sepracor) in which Sunovion "has acknowledged that two Mylan patents are valid, enforceable and infringed by Sunovion's Brovana product." Dey sued Sepracor in 2007 alleging that the latter's Brovana arformoterol tartrate … [Read more...] about Mylan and Sunovion settle Brovana patent infringement suit
Judge rules against Matrixx in Zicam case
"Under the 'ordinary consumer' standard, a product designed for intranasal use is expected not to cause irreparable injury to the nose if used in a foreseeable manner," said U.S. District Judge William Alsup in his decision allowing Californian Michael Nelson's lawsuit against the manufacturer of Zicam nasal gel and spray to go ahead. Nelson sued after losing his … [Read more...] about Judge rules against Matrixx in Zicam case
Recipharm borrows €90 million to finance expansion
Swedish contract developer and manufacturer Recipharm says that it has borrowed €90 million from Swedbank AB in order to finance additional contract pharmaceutical manufacturing capacity and acquisitions. The company says that it also plans to use a portion of the funding for "building and enhancing existing and new customer relationships." Recipharm has a dedicated … [Read more...] about Recipharm borrows €90 million to finance expansion
Prosonix closes Series B financing round
Inhaled drug developer Prosonix has announced the second closing of its Series B equity financing round, which was extended to £17.1M. A new investor, Gimv, added £5.7M to the funds from original syndicate members Ventech, Gilde Healthcare Partners, Entrepreneurs Fund, Quest for Growth, and Solon Ventures. Gimv Venture Capital Partner Karl Nägler will join the … [Read more...] about Prosonix closes Series B financing round
Pearl Therapeutics wins technology award
Pearl Therapeutics has won a 2012 TiE50 award from the Indus Entrepreneurs (TiE). Pearl was one of ten winners in the life sciences category. Pearl develops inhaled therapies based on its proprietary particle engineering technology. Pearl CEO Chuck Bramlage said, “The TiE organization awards start-ups that put a premium on entrepreneurial spirit, technological … [Read more...] about Pearl Therapeutics wins technology award
Aegis gets second patent for intranasal parathyroid hormone formulations
The US Patent and Trade Office has awarded a second patent, to Aegis Therapeutics for stabilized formulations of parathyroid hormone and parathyroid hormone analogs. The new patent (US Patent No. 8,173,594) covers formulations for both injection and nasal delivery that use Aegis's Intravail and ProTek excipients. Both patents have been licensed to Azelon … [Read more...] about Aegis gets second patent for intranasal parathyroid hormone formulations