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
News
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
CHMP recommends approval of aclidinium for COPD in Europe
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
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