According to a new report by the National Center for Health Statistics of the US Center for Disease Control (CDC), the 2009 US asthma rate rose to 8.2% of the population, a historic high. The report includes data from several national surveys. Nearly 96% of patients surveyed reported that they had been taught how to use an inhaler. Read the complete report. … [Read more...] about US asthma rate continues to increase
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Alkermes pulmonary delivery spin-out Civitas gets $20 million
Civitas Therapeutics has obtained $20 million in Series A financing for development of its lead product, a DPI intended for the treatment of Parkinson's disease. The assets Civitas has licensed from Alkermes include a pipeline, delivery technology, and a manufacturing facility. Management of the new company includes Glenn Batchelder, CEO; Richard Batycky, Chief … [Read more...] about Alkermes pulmonary delivery spin-out Civitas gets $20 million
Catalent adds DPI filling capacity
With the addition of new Harro Höfliger Omnidose filling equipment at its Research Triangle Park facility, Catalent now has the ability to provide DPI filling from clinical manufacturing through commercial manufacturing, according to the company. The new microdosing equipment can fill a range of DPI types, including both capsule and blister-based devices. Read the … [Read more...] about Catalent adds DPI filling capacity
Positive results for aclidinium alone and in combination with formoterol
Almirall and Forest Laboratories have announced that Phase 3 studies of inhaled aclidinium and Phase 2b studies of an inhaled aclidinium/formoterol combination both met their primary endpoints. As a result, the companies expect to submit regulatory applications for an aclidinium DPI for the treatment of COPD in the US and Europe in mid-2011 and will begin Phase 3 … [Read more...] about Positive results for aclidinium alone and in combination with formoterol
Ritedose recalls albuterol inhalation solution vials in US
Contract manufacturer Ritedose has voluntarily recalled unit dose vials of albuterol inhalation solution due to mislabeling. The single dose vials contain a 2.5 mg/3 mL solution but are labeled as 0.5 mg/3 mL. The product was distributed across the United States and in Puerto Rico. Read the company's press release. … [Read more...] about Ritedose recalls albuterol inhalation solution vials in US
Intranasal insulin company CPEX acquired
A subsidiary of Footstar has entered into an agreement to acquire New Hampshire specialty pharma company CPEX, which is developing Nasulin intranasal insulin spray. Nasulin is in Phase 2 development, and CPEX has been seeking to license the product or to sell the program outright. Read the company's press release. … [Read more...] about Intranasal insulin company CPEX acquired
Inspire’s CF drug fails Phase 3 trial
The results from Inspire Pharmaceuticals' second Phase 3 trial of denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis show that the drug failed to meet its primary endpoint, change in FEV from baseline. Denufosol is an ion channel regulator. A previous Phase 3 trial had produced significant change in FEV from baseline, and the company says … [Read more...] about Inspire’s CF drug fails Phase 3 trial
Mannkind announces delay on Afrezza decision
According to Mannkind Corporation, the FDA has informed the company that it will need another four weeks or so before it issues a decision on the NDA for Afrezza inhaled insulin. The original action date was to be December 29, 2010. The FDA issued a complete response letter for the product in March and requested additional data. Read the company's press release. … [Read more...] about Mannkind announces delay on Afrezza decision
Procept and Ingeniatrics to team up on new spray dryer system
Belgian pharma equipment manufacturer Procept and Spanish tech company Ingeniatrics Tecnologías have signed an agreement to develop a new spray drying system based on Ingeniatrics' Flow Focusing technology, which is a "microfluidic technology capable of monodispersed droplet formation and manipulation, based on the production of capillary microjets that are … [Read more...] about Procept and Ingeniatrics to team up on new spray dryer system
Strativa president John A. MacPhee resigns
Patrick G. LePore, President, CEO, and Chair of Par Pharmaceuticals will temporarily take over the reins at the company's subsidiary Strativa Pharmaceuticals after Strativa's President John A. MacPhee resigned. MacPhee was also Executive VP of Par. Strativa's products include Nascobal cyanocobalamin nasal spray. Read the company's press release. … [Read more...] about Strativa president John A. MacPhee resigns