Calls for papers
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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.… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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Forest Laboratories has reached an agreement with Gruenenthal to reacquire the European rights to the Colobreathe colistin DPI for the treatment of P. aeruginosa infections in cystic fibrosis patients.The EMA is currently reviewing Forest’s marketing… Read more . . .
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According to MAP Pharmaceuticals, it has completed a year-long open label safety trial of its Levadex inhaled dihydroergotamine, the final step in its development program for the product. More than 250 patients completed the 12-month… Read more . . .
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Generex has received a patent from the Canadian Intellectual Property Office for its aerosol drug delivery platform, its 162nd patent for the technology. Although the company announcement emphasizes its buccal delivery platform, the patent is… Read more . . .
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