OptiNose has announced Phase 3 results from a study of its sumatriptan nasal powder for the treatment of migraine, as well as a grant from the Research Council of Norway to study nasal delivery of oxytocin for the treatment of autism spectrum disorders. According to OptiNose US, the Phase 3 TARGET study found that 42% of patients with moderate to severe migraines … [Read more...] about OptiNose announces Phase 3 data, grant
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Pearl Therapeutics gets funding for Phase 3 studies of PT003
Pearl Therapeutics has raised $65 million from current investors to enable initiation of Phase 3 trials for its PT003 glycopyrrolate (GP)/formoterol fumarate (FF) MDI for the treatment of COPD, the company says. This round of financing brings the total to $167.5 million since 2007. Pearl CEO Chuck Bramlage said, “Through our comprehensive Phase 2 program, Pearl … [Read more...] about Pearl Therapeutics gets funding for Phase 3 studies of PT003
Savara’s AeroVanc gets orphan drug designation in US
According to Savara Pharmaceuticals, the company's AeroVanc inhaled vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients has been granted orphan drug status by the FDA. Aerovanc inhalation powder, which is delivered using a capsule-based DPI, has completed Phase 1 trials, and Savara says that it is … [Read more...] about Savara’s AeroVanc gets orphan drug designation in US
Novartis files application for QVA149 in Japan
QVA149 developers Vectura and Sosei have confirmed that Novartis has submitted an application for Japanese approval of the inhaled fixed dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of COPD. Novartis, which licensed the DPI from the two companies, also recently submitted an application for the product in Europe. Japan … [Read more...] about Novartis files application for QVA149 in Japan
Boehringer Ingelheim to double production at Respimat facility
Boehringer Ingelheim has announced an €85 million expansion to the BI microParts GmbH inhaler manufacturing facililty in Dortmund, Germany meant to double its annual production of Respimat inhalers to 44 million by 2015. Filling of the Respimat inhalers takes place in Ingelheim. The company says that it will need to add more than 100 new hires to the existing 450 … [Read more...] about Boehringer Ingelheim to double production at Respimat facility
FDA issues warning on ingestion of nasal sprays
The FDA has issued a warning to parents and health care professionals after receiving reports of accidental ingestion of nasal sprays and eye drops by children. According to the agency, the decongestant nasal sprays reported to have sickened children 5 years and younger who swallowed them had the active ingredients tetrahydrozoline or oxymetazoline. The warning … [Read more...] about FDA issues warning on ingestion of nasal sprays
Team Consulting, Lab Automate win awards
Two companies that provide services to OINDP developers and manufacturers have been awarded major prizes recently. The 2012 British Engineering Excellence Awards recognized device design experts Team Consulting as "Consultancy of the Year." Criteria for the award include, "the speed with which projects have been delivered," "the range of technologies handled by the … [Read more...] about Team Consulting, Lab Automate win awards
NICE approves Bronchitol inhalation powder for CF
Pharmaxis's Bronchitol mannitol dry powder for inhalation has become the first treatment for cystic fibrosis to receive a positive recommendation from he UK National Institute for Health and Clinical Excellence (NICE), according to the company. The recommendation allows for reimbursement by the National Health Service. Pharmaxis CEO Alan Robertson commented, … [Read more...] about NICE approves Bronchitol inhalation powder for CF
Novartis files MAA for QVA149
Novartis has filed a marketing application with the EMA for its QVA149 indacaterol maleate/glycopyrronium bromide DPI for the treatment of COPD. The filing triggered milestone payments of $5 million each to the drug's developers, Vectura and Sosei. Vectura Chief Executive Chris Blackwell, “The IGNITE program is among the largest COPD clinical trial programs … [Read more...] about Novartis files MAA for QVA149
GSK launches inhaler recycling program in US
According to the Associated Press, GlaxoSmithKline is extending its "Complete the Cycle" inhaler recycling program to 31 US cities, which were chosen because they account for about a third of all inhaler sales in the US, the company said. Patients will be able to drop off used inhalers at approximately 2,000 pharmacies in those cities. A statement about inhaler … [Read more...] about GSK launches inhaler recycling program in US