The FDA has granted Qualified Infectious Disease Product (QIDP) designation to Raptor Pharmaceutical's MP-376 inhaled levofloxacin for the treatment of chronic P. aeruginosa lung infections in patients with cystic fibrosis, non-cystic fibrosis bronchiectasis (BE), and nontuberculous mycobacteria (NTM). Raptor has previously received orphan designation from the FDA for … [Read more...] about Raptor’s inhaled levofloxacin gets QIDP status
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Study shows effectiveness of teach-to-goal inhaler education
A study published online ahead of print in the Annals of the American Thoracic Society (AnnalsATS) finds that a "teach-to-goal" inhaler education strategy reduced rescue inhaler misuse to 11% compared to 60% for a "brief instruction" approach immediately after education. Clinical outcomes were significant better for the teach-to-goal group, especially among patients … [Read more...] about Study shows effectiveness of teach-to-goal inhaler education
Apotex launches generic version of Nasonex in the US
Apotex has launched a generic version of Merck's Nasonex mometasone furoate nasal spray in the United States, the company said. In June 2012, A US District Court judge upheld a Merck patent on mometasone furoate (US Patent No. 6,127,353) but ruled that Apotex's nasal spray did not infringe on that patent. According to the FDA, the agency approved Apotex's ANDA for … [Read more...] about Apotex launches generic version of Nasonex in the US
Verona announces positive data from Phase 2a trial of RPL554
Verona Pharma has announced positive data from a Phase 2a study of RPL554, an inhaled PDE3/PDE4 inhibitor for the treatment of acute exacerbations in COPD patients. According to the company, asthma patients who received the nebulized RPL554 experienced no serious adverse events over the entire dose range of 0.4 to 24 mg and demonstrated a maximum bronchodilator effect … [Read more...] about Verona announces positive data from Phase 2a trial of RPL554
Grant available for deposition study
The US Department of Health and Human Services has announced that a grant of up to $200,000 is available for "Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug Products." One grant will be awarded. According to the March 15, 2016 announcement, "FDA's CDER is seeking depositional data obtained with a computational modeling … [Read more...] about Grant available for deposition study
Aradigm’s Pulmaquin will get EMA review under centralized procedure
Aradigm Corporation has announced that the EMA will review an Aradigm MAA for Pulmaquin inhaled liposomal ciprofloxacin under the centralized authorization procedure. According to the company, "Aradigm requested, and was granted, the centralized pathway on the basis that Pulmaquin represents a significant technical innovation for the potential treatment of non-cystic … [Read more...] about Aradigm’s Pulmaquin will get EMA review under centralized procedure
Vectura to acquire Skyepharma
Inhaled drug manufacturers Vectura and Skyepharma have announced a merger agreement in which Vectura will acquire Skyepharma for a total of £441 million ($638 million). Both boards have approved the merger. Vectura previously acquired Activaero in 2014. Vectura CEO James Ward-Lilley will continue as CEO and Vectura Chairman Bruno Angelici will continue as Chairman … [Read more...] about Vectura to acquire Skyepharma
MDI component manufacturer Presspart becomes H&T Presspart, plans to add new manufacturing sites
MDI component manufacturer Presspart has announced that it is now known as H&T Presspart to emphasize its status as a subsidiary of the Heitkamp & Thumann Group. The company said that it also plans to add manufacturing sites in Asia and the Americas in order to meet demand for MDI parts in those regions. Presspart already manufactures canisters and actuators in … [Read more...] about MDI component manufacturer Presspart becomes H&T Presspart, plans to add new manufacturing sites
MannKind announces 4th quarter results, management changes
According to MannKind Corporation, the company's net loss for 2015 was $368.4 million, and its cash and cash equivalents as of the end of 2015 totaled $59.1 million. The company also said that it has hired former Amgen VP, Global Commercial Lead Michael E. Castagna as its Chief Commercial Officer, effective immediately, and announced the resignation of Chief Operating … [Read more...] about MannKind announces 4th quarter results, management changes
Children’s Flonase now available OTC in the United States
GSK Consumer Healthcare has announced that Children's Flonase fluticasone propionate nasal spray is now available over the counter in the US. The FDA approved OTC sales of Flonase in July 2014, and the product has been available over the counter in the US since February 2015. Children's Flonase appears to be effectively identical to regular Flonase, with 50 mcg of … [Read more...] about Children’s Flonase now available OTC in the United States