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
News
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
New CEO for Meda
Meda, whose products include several nasal sprays and inhalers, has announced that Jörg-Thomas Dierks will replace Anders Lönner as CEO after Lönner decided to step down. Dierks joined Meda in 2005 and had served as Chief Operating Officer since then. Meda Chairman of the Board Bert Åke Eriksson said, “Anders Lönner has done outstanding work during his last 14 … [Read more...] about New CEO for Meda
Hovione announces successful FDA inspection
Inhalation particle design and manufacturing specialist Hovione has announced the completion of an FDA GMP and postmarket approval inspection of its manufacturing plant in Loures, Portugal. According to the company, no Form 483 was issued after the 5-day inspection, which was completed on September 27, 2013, and the inspector "informed that she was satisfied with what … [Read more...] about Hovione announces successful FDA inspection
Mystic gets additional patents for intranasal technology
Mystic Pharmaceuticals has announced that it has received a notice of allowance from the China Patent Office for a patent application titled “Deep Draw Container Forming Method” (invention number ZL200880106965.1). The company also said that it received a notice of allowance for an application titled “Combination Unit Dose Dispensing Container” (application number … [Read more...] about Mystic gets additional patents for intranasal technology
Malvern Instruments acquires NanoSight
Particle characterization company Malvern Instruments has announced its acquisition of UK-based nanoparticle characterization specialist NanoSight. NanoSight's instruments can analyze particle size, concentration, zeta potential, and aggregation of nanoparticles. Malvern Instruments Managing Director Paul Walker comented, “NanoSight is a real entrepreneurial … [Read more...] about Malvern Instruments acquires NanoSight
Transcept licenses intranasal DHE
Transcept Pharmaceuticals has acquired global development and commercialization rights to Shin Nippon Biomedical Laboratories' TO-2070 dihydroergotamine (DHE) nasal powder for the treatment of migraine, the companies announced. Transcept will pay $1 million up front plus development milestones totaling $6.5 million, commercialization milestones of up to $35 million, … [Read more...] about Transcept licenses intranasal DHE