Finnish nanonization specialists Nanoform have filed for GMP certification with the Finnish Medicines Agency (FIMEA), the company said. In December 2018, Nanoform announced construction of a new GMP manufacturing facility in Helsinki. The company, which recently won the the 2019 Excellence in Pharma: Formulation award at CPhI, plans to offer GMP clinical … [Read more...] about Nanoform applies for GMP certification
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Ryaltris nasal spray approved in Australia
Australia's Therapeutic Goods Administration has approved Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of allergic rhinitis and rhinoconjunctivitis, Glenmark Pharmaceuticals said. The marketing application was submitted by Seqirus, which acquired Australian commercialization rights to the nasal spray in July 2018. Glenmark said … [Read more...] about Ryaltris nasal spray approved in Australia
DDL 2019 highlighted sustainability issues in the inhaled drug delivery industry
For the second year in a row, the annual Drug Delivery to the Lungs meeting drew more than 850 OINDP specialists and 110 exhibitors to the Edinburgh International Conference Centre to catch up on the latest in inhalation research and technology. Much of the meeting focused on issues of sustainability, with discussion centered on reducing the carbon footprint of … [Read more...] about DDL 2019 highlighted sustainability issues in the inhaled drug delivery industry
Recipharm adds SprayView system to OINDP testing facility
CDMO Recipharm has announced an investment of $450,000 for installation of a Proveris Scientific SprayView Measurement System at its facility in Research Triangle Park, North Carolina. The company described the SprayView system as "an important tool that can visualize changes in other critical quality attributes (CQAs) of inhaled and nasal products" and said that it … [Read more...] about Recipharm adds SprayView system to OINDP testing facility
Spravato approved in Europe
The European Commission has approved Janssen Pharmaceutical's Spravato esketamine nasal spray for the treatment of treatment-resistant major depressive disorder, the company said. The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the MAA for Spravato in October 2019. The FDA approved Spravato for the same … [Read more...] about Spravato approved in Europe
Positive topline results for Phase 2/3 trial of Biohaven’s intranasal vazegepant for migraine
Biohaven Pharmaceutical has announced that a Phase 2/3 trial of its intranasal vazegepant (BHV-3500) demonstrated that 10 and 20 mg doses of the intranasal migraine therapy were more effective than placebo for pain relief and that the drug was well tolerated with no indication of liver toxicity. Biohaven announced the initiation of the study in April 2019. The … [Read more...] about Positive topline results for Phase 2/3 trial of Biohaven’s intranasal vazegepant for migraine
3M Drug Delivery Systems sold to Altaris Capital Partners
3M has announced the sale of "substantially all" of 3M Drug Delivery Systems to Altaris Capital Partners for approximately $650 million. 3M will keep a 17% interest in the new business, which is expected to employ approximately 900 of the current employees after the sale is completed. 3M's inhalation products include standard MDIs, a nasal MDI, and the Intelligent … [Read more...] about 3M Drug Delivery Systems sold to Altaris Capital Partners
Oxford Lasers opens contract aerosol imaging facility
Spray characterization specialists Oxford Lasers have opened a new contract services facility to provide drug delivery device testing at their site in Didcot, UK, the company said. Oxford Lasers Imaging Division Manager Seamus Murphy said, “This marks a new milestone for the Oxford Lasers Imaging division. We have been providing services and systems into the … [Read more...] about Oxford Lasers opens contract aerosol imaging facility
Windtree Therapeutics announces completion of $26.4 million private placement
Aerosurf inhaled surfactant developer Windtree Therapeutics has announced the completion of a $26.4 million private placement of common stock and warrants. Net proceeds were approximately $23 million. Windtree is developing several inhaled drugs delivered via the company's proprietary Aerosol Delivery System (ADS). In addition to Aerosurf inhaled KL4 surfactant, … [Read more...] about Windtree Therapeutics announces completion of $26.4 million private placement
VistaGen’s PH94B nasal spray for social anxiety disorder gets Fast Track designation
VistaGen Therapeutics has announced that its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD) has received Fast Track designation from the FDA. The company says that it is preparing to conduct Phase 3 trials of the nasal spray. In September 2018, VistaGen announced that it had acquired exclusive global rights to PH94B from Pherin … [Read more...] about VistaGen’s PH94B nasal spray for social anxiety disorder gets Fast Track designation