Consort Medical has announced record revenue and profits for the year ending April 30, 2012, including a 12% increase in revenue for its Bespak division, which manufactures metered dose inhaler valves and actuators as well as dry powder inhalers. Bespak's operating profit also grew by 17%. According to Consort, the growth in Bespak revenue came about in part due to … [Read more...] about Bespak MDI valve sales up 12%
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Savara announces Phase I study results for AeroVanc, funding for Phase 2
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
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
Alnylam inhaled RSV drug misses primary endpoint in Phase 2b study
Alnylam Pharmaceuticals says that its ALN-RSV01 inhaled RNAi drug failed to meet the primary endpoint of a Phase 2b study, not significantly reducing the incidence of bronchiolitis obliterans syndrome (BOS) at 180 days after infection in lung transplant patients infected with respiratory syncytial virus (RSV) in an “intent-to-treat” (ITTc) analysis, but that it met … [Read more...] about Alnylam inhaled RSV drug misses primary endpoint in Phase 2b study
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
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