Rigel Pharmaceuticals says it will assume development responsibilities for R343, an inhaled syk inhibitor for the treatment of allergic asthma after Pfizer returned all rights to the program. Pfizer had licensed R343, along with other inhaled syk inhibitors, from Rigel in 2005. R343 works by binding to syk, a protein tyrosine kinase in mast cells involved in IgE … [Read more...] about Pfizer returns rights to Rigel’s inhaled syk inhibitor
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GSK makes additional investment in Theravance
According to reports, GlaxoSmithKline has invested an additional $6.7 million in Theravance, its partner in developing a number of inhaled asthma and COPD drugs. The purchase of common stock gives GSK approximately 19% of Theravance's outstanding shares. GSK and Theravance have worked together on inhalation product development since 2002 and have their Relovair … [Read more...] about GSK makes additional investment in Theravance
Prosonix particle technology now in use at Sterling
Steroid manufacturers Sterling S.r.l., located in Perugia, Italy, is now producing APIs for respiratory delivery using particle engineering technology supplied by Prosonix. A two-year collaboration between the two companies has resulted in a retrofit of existing Sterling equipment at the company's FDA-approved facility. The Prosonix crystallization technology … [Read more...] about Prosonix particle technology now in use at Sterling
MicroDose Therapeutx reaches milestone in Novartis agreement
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
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