MicroDose Therapeutx has announced that it has achieved a milestone that "signals the successful incorporation of MicroDose’s DPI technology into a Novartis platform pulmonary device" and triggers a milestone payment from Novartis. The two companies entered into a development and licensing agreement for five products in June 2006. According to a press release at … [Read more...] about MicroDose Therapeutx reaches milestone in Novartis agreement
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Positive Phase 2 results for ISTA’s bepotastine besilate nasal spray
A Phase 2 clinical trial of its bepotastine besilate nasal spray for the treatment of seasonal allergic rhinitis has demonstrated significantly significant improvement in total nasal symptoms compared to placebo, announced ISTA Pharmaceuticals. The study involved approximately 600 patients suffering from seasonal allergy symptoms caused by mountain cedar pollen. … [Read more...] about Positive Phase 2 results for ISTA’s bepotastine besilate nasal spray
FDA will not appeal ruling on electronic cigarettes
The US FDA has issued a letter informing stakeholders that it will not appeal a December 2010 ruling by the US Court of Appeals for the DC Circuit that the agency has no authority to regulate electronic cigarettes as drug/device combinations unless the manufacturers marketed the products for "therapeutic" use. According to the agency, it intends to take actions … [Read more...] about FDA will not appeal ruling on electronic cigarettes
OINDP suppliers receive Queen’s Awards for Enterprise
A number of companies that provide products and services to developers and manufacturers of inhaled and nasal drug products have been named as recipients of the 2011 Queen's Awards for Enterprise. The Queen presents the awards annually to UK businesses "for outstanding achievement by UK businesses in the categories of Innovation, International Trade and Sustainable … [Read more...] about OINDP suppliers receive Queen’s Awards for Enterprise
Sprix nasal spray unaffected by Luitpold shutdown
According to Luitpold Pharmaceuticals, its suspension of both manufacturing at its Shirley, NY facility and distribution of products manufactured at that location, will not affect Sprix ketorolac tromethamine nasal spray. The company says that it voluntarily stopped production prior to an April 14 meeting with the FDA to follow up on recent inspections and agreed to … [Read more...] about Sprix nasal spray unaffected by Luitpold shutdown
NanoBio developing intranasal vaccine to prevent urinary tract infections
The University of Michigan will license an antigen to NanoBio Corporation for development of a nasal vaccine using NanoBio's NanoStat technology for the prevention of urinary tract infections (UTIs). The antigen works by eliminating E. coli bacteria in the urinary tract. NanoBio's press release cites statistics showing that more than half of all women suffer from UTIs … [Read more...] about NanoBio developing intranasal vaccine to prevent urinary tract infections
Gilead licenses MicroDose inhalation powder for the treatment of RSV
Gilead Sciences and MicroDose Therapeutx have reached an agreement for the development and commercialization of MDT-637, a small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus (RSV). The dry powder formulation is designed for pulmonary delivery using MicroDose's proprietary DPI. The deal includes an upfront payment from Gilead … [Read more...] about Gilead licenses MicroDose inhalation powder for the treatment of RSV
NVA237 meets primary endpoint in Phase 3 study
NVA237, a once daily, long acting muscarinic agent (LAMA) DPI for the treatment of COPD, met its primary endpoint of improved bronchodilation compared to placebo after 12 weeks. The glycopyrronium bromide dry powder formulation was licensed to Novartis by Sosei and Vectura in 2005. Novartis announced the results in its first quarter 2011 earnings report, along … [Read more...] about NVA237 meets primary endpoint in Phase 3 study
Axcan to acquire Mpex and its inhaled levofloxacin
European specialty pharma company Axcan will acquire Mpex Pharmaceuticals and its lead candidate, Aeroquin levofloxacin inhalation solution for the treatment of Pseudomonas aeruginosa infections in CF patients, which is currently in Phase 3 trials. Axcan plans to complete development of Aeroquin itself and spin off Mpex's other assets into a separate company. Mpex … [Read more...] about Axcan to acquire Mpex and its inhaled levofloxacin
New date for MannKind end-of-review meeting
The FDA has rescheduled its end-of-review meeting with MannKind Corporation regarding Afrezza inhaled insulin for May 4, 2011. The agency had earlier cancelled the meeting, which had been scheduled for April 15, due to a potential government shutdown. At one time, the FDA had planned to complete its review by December 29, 2010 but requested additional time to … [Read more...] about New date for MannKind end-of-review meeting