As GSK announced its 2011 results, which included sales declines for Advair (Seretide) in the US and Europe, and after the announcement that it plans to file a marketing application for its Relovair fluticasone furoate/vilanterol DPI despite disappointing data, Bloomberg took note of GSK's recent study of a cheaper capsule-based inhaler for delivery of Advair … [Read more...] about GSK tests Rotacaps inhaler versus Diskus for Advair
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Akela gets funding for its PharmaForm subsidiary
Akela Pharma has announced completion of a private placement totaling $2,310,000 that it will use primarily for expansion of spray drying and hot melt extrusion capabilities at its subsidiary, PharmaForm. Although PharmaForm specializes in solid dosage forms, it also offers services for nasal sprays and dry powder formulation development. The parent company, … [Read more...] about Akela gets funding for its PharmaForm subsidiary
Almirall files new applications for Sativex in Europe
Almirall has announced the filing of new applications for its Sativex endocannabinoid oromucosal spray for the treatment of spasticity in multiple sclerosis in ten additional countries: Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia. The product is currently available in Denmark, Germany, Spain, UK, Canada, and … [Read more...] about Almirall files new applications for Sativex in Europe
Team Consulting opens new respiratory physics laboratory
Team Consulting has announced the opening of its new Respiratory Physics Laboratory at the company headquarters in Ickleton, Cambridgeshire, UK. Recent hire Mark Shepherd will manage the cGMP laboratory. “In recent years we have worked for six of the world’s top ten pharma companies and for them it is important to see us making this investment in facilities and … [Read more...] about Team Consulting opens new respiratory physics laboratory
FDA clears Neurelis IND for intranasal diazepam
The FDA has accepted an Investigational New Drug application (IND) submitted by San Diego, CA pharmaceutical company Neurelis. The company is cleared to begin clinical trials for the development of its NRL-1 intranasal diazepam for the treatment of acute breakthrough seizures. According to the company, it filed the IND "based upon the encouraging human pharmacokinetic … [Read more...] about FDA clears Neurelis IND for intranasal diazepam
PhRMA report lists more than 50 drugs in US COPD pipeline
According to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA), American pharmaceutical companies have 54 COPD medications in their pipelines. The list of drugs in development includes all dosage forms, including a large number of inhaled medications. PhRMA President and CEO John J. Castellani commented, “Early detection of COPD is … [Read more...] about PhRMA report lists more than 50 drugs in US COPD pipeline
New inhalation consortium formed in Scandinavia
The new Medicon Valley Inhalation Consortium (MVIC) includes seven inhalation technology companies located in the Skåne-Copenhagen region of Scandinavia. According to the consortium, it "will work to globally promote Medicon Valley as an international center of inhalation competence and offer a comprehensive set of world class services." Many of the member … [Read more...] about New inhalation consortium formed in Scandinavia
Recall of acetylcysteine inhalation solution
Bedford Laboratories has announced a national (US) voluntary product recall of acetylcysteine solution manufactured for Roxane Laboratories. The recall was initiated on December 20, 2011 due to a visible glass particle in a vial of solution from lot 1877093. According to the company, no adverse events have been reported. The company warned that "Use of an inhaled … [Read more...] about Recall of acetylcysteine inhalation solution
Prosonix appoints Geoff Down as Chief Medical Officer
Prosonix has announced the appointment of Geoff Down to the newly-created position of Chief Medical Officer, effective immediately. Down, who has extensive experience in clinical development and has served various roles, some as a consultant pharmaceutical physician, for Pfizer, Respivert, GSK, and other companies, will oversee clinical development of the Pronsonix … [Read more...] about Prosonix appoints Geoff Down as Chief Medical Officer
Optinose files IND for intranasal sumatriptan
According to OptiNose, it filed an investigational new drug (IND) application for an intranasal sumatriptan product with the US FDA in December, 2011, and the FDA has given OptiNose permission to proceed. The company now plans to begin Phase 3 trials in adults with acute migraine. “This filing signals an important milestone in our quest to deliver improved relief … [Read more...] about Optinose files IND for intranasal sumatriptan