According to reports, Takeda Pharmaceutical is looking to buy Swiss pharma company Nycomed, which manufactures several OINDPs, including the Alvesco ciclesonide MDI and Omnaris ciclesonide nasal spray. Nycomed is also developing a ciclesonide HFA nasal aerosol in partnership with Sunovion (formerly Sepracor); that product is currently in Phase 3. Takeda is … [Read more...] about Takeda reportedly pursuing Nycomed
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MannKind reveals details of latest FDA review meeting
Five days after its end of review meeting with the FDA on May 4 regarding its Afrezza inhaled insulin, MannKind Corporation held a conference call to update its progress and financial situation. During the call, Alfred Mann characterized the meeting as "positive and collaborative, resulting in a redirection of the Type 2 trial that should enable us to support use of … [Read more...] about MannKind reveals details of latest FDA review meeting
Hovione announces successful GMP inspections
Over the past 8 months, says API developer and manufacturer Hovione, its facilities have undergone a total of 6 inspections by the US FDA, the Japanese PMDA, and the Portuguese authorities. Pre-approval inspections for 2 new products for customer synthesis, and for existing molecules used in new formulations, took place at the company's facilities in New Jersey, … [Read more...] about Hovione announces successful GMP inspections
Pfizer returns rights to Rigel’s inhaled syk inhibitor
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
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
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