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
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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
Discovery Labs gets authorization for Afectair device in US
Discovery Laboratories has announced that the FDA has approved the Afectair device for marketing in the US, and the company plans a launch later this year. The company describes Afectair as "a proprietary patient interface technology that simplifies delivery of aerosolized medications to patients requiring ventilator support" and estimates that it could bring in … [Read more...] about Discovery Labs gets authorization for Afectair device in US
Mark Shepherd, Ben Cox join Team Consulting
Team Consulting has announced two new hires: Mark Shepherd, formerly Physical Properties Scientist in respiratory product development at GSK, and Human Factors and User Research Consultant Ben Cox. Shepherd, who has experience with dry powder and intranasal compounds, will be responsible for laboratory quality systems and procedures. “Having spent many years … [Read more...] about Mark Shepherd, Ben Cox join Team Consulting
Impax acquires rights to Zomig nasal spray
California-based Impax Pharmaceuticals has acquired exclusive US rights to several dosage forms of Zomig zolmitriptan, including the nasal spray formulation, from AstraZeneca. Zomig nasal spray is approved in the US for the treatment of migraine headaches. The agreement also gives Impax non-exclusive rights to develop and commercialize new zolmitriptan products. … [Read more...] about Impax acquires rights to Zomig nasal spray
Skye Pharma CEO Axel Mueller resigns
SkyePharma CEO Axel Mueller has resigned "to pursue other interests," according to the company, and will be replaced by current Chief Financial Officer Peter Grant. The company's announcement says that Grant, who has been CFO since 2006, "will retain responsibility for the Group's financial matters and will oversee the continuing activities to achieve Flutiform … [Read more...] about Skye Pharma CEO Axel Mueller resigns