Novartis has filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for its NVA237 glycopyrronium bromide dry powder inhaler, which will be called the Seebri Breezhaler. The MAA once-daily long-acting antimuscarinic (LAMA) triggered a $5 million milestone payment to Sosei, which co-developed the product with Vectura and licensed it … [Read more...] about Novartis has filed MAA for Seebri Breezhaler in Europe
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Amirall presents full data for Phase 3 ATTAIN study of aclidinium bromide at ERS
Almirall has presented a number of posters at the 2011 Annual Congress of the European Respiratory Society (ERS), including, for the first time, full data from the six-month Phase 3 ATTAIN study of its aclidinium bromide dry powder inhaler for the treatment of moderate-to-severe COPD. The data show that twice-daily doses of either 200 μg or 400 μg of aclidinium … [Read more...] about Amirall presents full data for Phase 3 ATTAIN study of aclidinium bromide at ERS
MicroDose begins Phase 1 trial of novel dry powder nebulized treatment for RSV
MicroDose Therapeutx has initiated a Phase 1 clinical trial of MDT-637, an inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus (RSV) that is delivered using the company's novel dry powder nebulizer. MicroDose is developing MDT-637 in partnership with Gilead Sciences and will develop the product through Phase 2a trials. … [Read more...] about MicroDose begins Phase 1 trial of novel dry powder nebulized treatment for RSV
Prosonix adds Ken Cunningham to its Board of Directors
Former SkyePharma CEO and current Executive Chairman of PolyTherics Ken Cunningham has joined the Board of Directors of inhaled drug developer Prosonix as a Non-Executive Director. Cunningham will also serve as Chair of the Prosonix Advisory Board. Prosonix is developing several inhaled therapies for asthma and COPD based on its proprietary particle engineering … [Read more...] about Prosonix adds Ken Cunningham to its Board of Directors
Pearl Therapeutics announces positive Phase 2b results for PT003 inhaler
Two posters presented by Pearl Therapeutics at the 2011 European Respiratory Society meeting show additional data from a Phase 2b study demonstrating that Pearl's glycopyrrolate (GP)/fomoterol fumarate (FF) fixed combination metered dose inhaler and its PT001 GP monotherapy MDI both provide greater inspiratory capacity than Spiriva Handihaler tiotropium dry powder … [Read more...] about Pearl Therapeutics announces positive Phase 2b results for PT003 inhaler
Elevation Pharmaceuticals appoints two new executives
Shortly after announcing positive Phase 2a results for its glycopyrrolate inhalation solution, Elevation Pharmaceuticals, announced that it has appointed Jaisim Shah as Senior Vice President and Chief Business Officer and Pravin Soni as Senior Vice President and Chief Technical Officer. Both positions are newly created. "Mr. Shah and Dr. Soni bring strong … [Read more...] about Elevation Pharmaceuticals appoints two new executives
Intranasal insulin and PTH formulations for sale
Marina Biotech (formerly MDRNA/Nastech) is offering intellectual property related to intranasal formulations of rapid-acting insulin and of parathyroid hormone (PTH) for the treatment of osteoporosis for sale through ICAP Patent Brokerage. ICAP has recently handled a number of portfolios related to inhalation and nasal delivery, offering several at live auction in … [Read more...] about Intranasal insulin and PTH formulations for sale
Phase 3 studies presented at ERS show efficacy and safety of Flutiform
According to Mundipharma, three Phase 3 studies of the Flutiform fluticasone propionate/formoterol fumarate metered dose inhaler (MDI) have demonstrated that the product "had comparable efficacy in improving the lung function and a similar safety profile to budesonide/formoterol, a licensed combination asthma therapy," "was as effective in treating asthma as … [Read more...] about Phase 3 studies presented at ERS show efficacy and safety of Flutiform
Positive Phase 2a results for Elevation’s glycopyrrolate inhalation solution
Elevation Pharmaceuticals has presented positive results from a Phase 2a study of its glycopyrrolate inhalation solution in patients with moderate to severe COPD at the European Respiratory Society (ERS) meeting in Amsterdam. If Elevation can bring the formulation, known as EP-101, to market, it would be the first long-acting muscarinic antagonist (LAMA) available for … [Read more...] about Positive Phase 2a results for Elevation’s glycopyrrolate inhalation solution
MannKind looking to raise $370 million for continued development of Afrezza
MannKind Corporation has announced a proposed offer of senior secured discount notes, due 2017, that would yield approximately $370 million. The company says that it would use the money to complete Phase 3 clinical trials of its Afrezza inhaled insulin, to prepare for commercialization of the product, and for work on its manufacturing plant in Danbury, CT, among other … [Read more...] about MannKind looking to raise $370 million for continued development of Afrezza