AIT’s nitric oxide product for CF gets European orphan designation

Advanced Inhalation Therapies (AIT) has announced that its AIT-CF high dose inhaled formulation of nitric oxide (NO) for the treatment of cystic fibrosis has been granted orphan medical product designation by the European Commission. In February 2015, the company announced that the product had received orphan drug designation from the FDA in late 2014. AIT . . . Read more

FDA approves Breo Ellipta for the treatment of asthma in adults

The FDA has approved GSK’s supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was approved by the FDA for the treatment of COPD in May 2013. In March 2015, the FDA’s Pulmonary-Allergy Drugs Advisory . . . Read more

Alexza Pharmaceuticals announces promotions

Inhaled drug developer Alexza Pharmaceuticals has announced the promotions of Edwin S. Kamemoto to Executive VP, R&D and Quality and Lori H. Takahashi to VP, Pharmaceutical R&D and Quality. Both positions are newly created. Kamemoto joined Alexza in 2006 and was most recently Senior VP, Regulatory Affairs. Takahashi joined Alexza in 2005 and most recently . . . Read more