Swedish device developer Iconovo has received a $350,000 grant from Swedish innovation agency Vinnova for continued development of the company's ICOone unit-dose disposable dry powder inhaler, the company said. Iconovo, which is located at the Lund Life Science Incubator recently won a Lund University Innovation Award for an inhaled vaccine project using the … [Read more...] about Iconovo receives grant for DPI development from Swedish innovation agency
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RODES Inc licenses Captisol-enabled intranasal budesonide/azelastine from Ligand
RODES, Inc. and Ligand Pharmaceuticals have announced global license and supply agreements for three products in development using Ligand's Captisol formulation technology, including intranasal budesonide/azelastine for the treatment of allergic rhinitis. RODES will pay all development and commercial costs, make milestone payments, and pay royalties of 8% - 11% on … [Read more...] about RODES Inc licenses Captisol-enabled intranasal budesonide/azelastine from Ligand
Aptar Pharma to introduce new MDI metering valve at DDL 26
Aptar Pharma will introduce its new DF30Plus metering valve at this year's Drug Delivery to the Lungs conference, the company said. The DF30Plus is based on the company's widely-used DF30 metering valve and features a cyclic olefin copolymer (COC) neck gasket developed at Aptar's in-house Elastomer Center, which offers ultra-low extractable levels and is compatible … [Read more...] about Aptar Pharma to introduce new MDI metering valve at DDL 26
Phase 1 clinical trial of Acorda’s inhaled zolmitriptan gets underway
Enrollment has begun for a Phase 1 clinical study of Acorda Therapeutics' CVT-427 zolmitriptan DPI for the treatment of migraines, the company said. The single ascending dose study, which is expected to enroll 32 healthy adults, will assess the safety and tolerability of four doses of CVT-427 and will compare the pharmacokinetics of the inhaled drug to the … [Read more...] about Phase 1 clinical trial of Acorda’s inhaled zolmitriptan gets underway
InCarda Therapeutics establishes Australian subsidiary
US inhaled drug developer InCarda Therapeutics has launched a subsidiary business in Australia in preparation for its first clinical trial, which is scheduled for the first half of 2016, the company said. According to InCarda, it is already manufacturing and testing formulations in Australia and has entered into agreements with Australian CROs. In April 2015, … [Read more...] about InCarda Therapeutics establishes Australian subsidiary
Propeller Health to develop sensor for Ellipta DPI
Inhaler monitoring company Propeller Health has announced that it will develop a sensor for GSK's Ellipta dry powder inhaler for use in gathering inhaler usage data during clinical trials. GSK also has the option to obtain exclusive rights for a version of the sensor to be included with its marketed Ellipta products. Propeller's monitoring system was approved by … [Read more...] about Propeller Health to develop sensor for Ellipta DPI
Indivior receives Complete Response Letter for naloxone nasal spray
Less than a week after the FDA approved Adapt Pharma's Narcan naloxone nasal spray for the treatment of opioid overdose, the agency has issued a Complete Response Letter to Indivior's NDA for its naloxone nasal spray, Indivior said. Indivior submitted the NDA in July 2015. According to the company, "The FDA’s response was principally focused on clinical … [Read more...] about Indivior receives Complete Response Letter for naloxone nasal spray
Circassia’s fluticasone propionate MDI approved in UK based on in vitro data only
According to Circassia Pharmaceuticals, the UK has approved the company's generic fluticasone propionate MDI for the treatment of asthma under the European decentralized procedure. The MAA includes the same three strengths (50µg, 125µg and 250µg per actuation) as GSK's Flixotide fluticasone propionate MDI, and the company will now submit marketing applications in … [Read more...] about Circassia’s fluticasone propionate MDI approved in UK based on in vitro data only
Sumatriptan nasal spray shortage expected to last until February 2016
According to the FDA, GlaxoSmithKline has reported that 20 mg and 5 mg dosages of its Imitrex nasal spray for the treatment of migraine headaches will be unavailable until February 2016 due to an API shortage. The shortage, which was reported to the FDA on November 20, 2015, affects both dosages of an authorized generic sumatriptan nasal spray distributed by Sandoz … [Read more...] about Sumatriptan nasal spray shortage expected to last until February 2016
Hakan Edstrom steps down as CEO of MannKind Corporation
MannKind Corporation has announced the resignation of Hakan Edstrom, who was the company's President and CEO, as well as a director. In the wake of the resignation, Alfred Mann has been appointed interim CEO, effective November 19, 2015, and a board committee has begun a search for a new CEO. Edstrom took over as CEO from Mann in January 2015, prior to Sanofi's … [Read more...] about Hakan Edstrom steps down as CEO of MannKind Corporation