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
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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
Positive results in artificial pancreas plus inhaled insulin study
Diabetes research organization JDRF, along with Sansum Diabetes Research Institute, and the College of Engineering at University of California, Santa Barbara (UCSB) have announced positive results from a trial of an artificial pancreas used in conjunction with inhaled insulin taken at mealtimes. In 2010, MannKind Corporation announced that it would provide Afrezza … [Read more...] about Positive results in artificial pancreas plus inhaled insulin study
European approval for Ultibro Breezhaler
Just days after its approval in Japan, Novartis has announced that the Ultibro Breezhaler indacaterol/glycopyrronium (QVA149) DPI has been approved in Europe for the treatment of COPD. The approval triggers $10 million milestone payments to Sosei and Vectura. Novartis Pharmaceuticals Division Head David Epstein commented, "We are very pleased that the European … [Read more...] about European approval for Ultibro Breezhaler
Positive opinion on Fluenz Tetra from CHMP
According to AstraZeneca, it has received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) for its Fluenz Tetra intranasal four-strain live attenuated influenza vaccine developed by its MedImmune subsidiary. Fluenz Tetra includes two strains of influenza A and two strains of influenza B. If approved, the vaccine would replace … [Read more...] about Positive opinion on Fluenz Tetra from CHMP