Inhalation testing automation specialist Astech Projects has announced the launch of a new website at www.astechprojects.com. The new site allows for easier access to information about the company's business units, including drug delivery automation. The company offers semi- and fully-automated systems for testing aerodynamic particle size distribution, dose … [Read more...] about Astech Projects launches new web site
News
Aesica announces expanded inhalation services
UK-based CDMO Aesica has announced that it will expand its services related to inhalation product development and manufacturing at its Nottingham site and that it plans to open a new inhalation technical center in late 2014. The company said that it has recently added spray drying and powder filling capabilities, as well as a number of new hires in the inhalation … [Read more...] about Aesica announces expanded inhalation services
MannKind resubmits Afrezza NDA
According to MannKind Corporation, the company resubmitted its new drug application for Afrezza insulin inhalation powder for the treatment of type 1 and type 2 diabetes to the FDA on October 13, 2013. The resubmitted application includes all data from the product's clinical development program, the company said. Earlier this year, MannKind announced positive results … [Read more...] about MannKind resubmits Afrezza NDA
Teva’s generic tobramycin inhalation solution approved by FDA
Teva has announced that the US FDA has approved its tobramycin inhalation solution, a generic equivalent to Novartis's TOBI inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients. According to Teva, the company will launch the product in November 2013 in accordance with an agreement with Novartis. Teva UK's marketing … [Read more...] about Teva’s generic tobramycin inhalation solution approved by FDA
Nephron recalls albuterol inhalation solution
Nephron Pharmaceuticals has announced a voluntary recall of ten lots of albuterol inhalation solution "as a precautionary measure, due to results from . . . internal monitoring processes." The company says that it has not received reports of reportable adverse events for the 0.083% solution and that the lots met Nephron's quality specifications when … [Read more...] about Nephron recalls albuterol inhalation solution
FDA approves non-prescription Nasacort Allergy 24HR nasal spray
Sanofi has announced today that its Nasacort Allergy 24HR triamcinolone acetonide nasal spray for the treatment of nasal allergies will be available over-the-counter beginning in spring 2014 now that the FDA has approved it as an OTC product. Sanofi's consumer healthcare division, Chattem, Inc. will market the product. An FDA advisory committee recommended approval … [Read more...] about FDA approves non-prescription Nasacort Allergy 24HR nasal spray
Teva announces plans for expanded respiratory business
During a recent web presentation on its respiratory R&D activities, Teva announced that it plans to make 13 regulatory submissions for respiratory products over the next 5 years, introduce "proprietary devices addressing unmet needs," and expand its respiratory business to become "a multi-billion $ franchise by the end of the decade." According to the company, its … [Read more...] about Teva announces plans for expanded respiratory business
European Parliament rejects regulation of e-cigarettes as medicines
The European Parliament has voted to regulate e-cigarettes under less stringent rules than drug delivery products, unless the products make medical claims. The Parliament voted to prohibit sales of e-cigarettes to any one under 18 years old, to limit products to 30mg/ml of nicotine, and to require health warnings. Linda McAvan, the member designated as the lead … [Read more...] about European Parliament rejects regulation of e-cigarettes as medicines
Cirrus gets FDA grant for MDI formulation study
The US FDA has awarded a grant to Cirrus Pharmaceuticals for a study titled “Comprehensive Evaluation of Formulation Effects on Metered Dose Inhaler Performance,” the company has announced. According to Cirrus, the study will "investigate the effects of excipient concentrations and API particle size on the aerosolization performance of metered dose inhaler (MDI) … [Read more...] about Cirrus gets FDA grant for MDI formulation study
Orphan drug designation for inhaled lipid-complexed cisplatin
According to Eleison Pharmaceuticals, the European Commission has granted Orphan Drug Designation for the company's inhaled lipid-complexed cisplatin (ILC) for the treatment of osteosarcoma. The sustained-release inhalation solution, which Eleison licensed from Insmed in 2011, is currently in a Phase 2 clinical trial. Eleison Chief Medical Officer Forrest Anthony … [Read more...] about Orphan drug designation for inhaled lipid-complexed cisplatin