The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Almirall's Eklira Genuair aclidinium DPI for the treatment of COPD. The Genuair inhaler is a proprietary multidose, cartridge-based dry powder inhaler. Almirall Chief Scientific Officer Bertil Lindmark commented,”The … [Read more...] about CHMP recommends approval of aclidinium for COPD in Europe
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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
FDA approves generic version of Astelin nasal spray
According to Sun Pharma, the FDA has approved an Abbreviated New Drug Application (ANDA) for a generic version of azelastine nasal spray submitted by a Sun subsidiary. Sun notes that the US sales of azelastine nasal spray are about $144 million annually. Astelin and Astepro azelastine sprays are distributed in the US by Meda. Astepro is a newer formulation … [Read more...] about FDA approves generic version of Astelin nasal spray
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
Boehringer Ingelheim announces results from studies of olodaterol and tiotropium
Boehringer Ingelheim has presented data from studies of olodaterol and tiotropium at the 2012 Annual Meeting of the American Thoracic Society. According to the company, it has now completed its Phase 2 trials of olodaterol, delivered via the Respimat soft mist inhaler, as a monotherapy for COPD, and that Phase 3 trials are also complete. BI is also developing a fixed … [Read more...] about Boehringer Ingelheim announces results from studies of olodaterol and tiotropium
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
Gateway Analytical offering two webinars for OINDP specialists
Particle characterization specialist Gateway Analytical is offering two upcoming webinars of interest to OINDP developers, manufacturers, and quality assurance personnel. The first of the webinars, Ensure Quality Inhalation Products with Wear Debris Analysis of Medical Devices, will take place on May 30. The one-hour webinar will cover causes of wear debris in … [Read more...] about Gateway Analytical offering two webinars for OINDP specialists
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