Discovery Laboratories says that it will use the $1.9 million it has received from the National Heart, Lung, and Blood Institute (NHLBI) for a Phase 2a trial of Aerosurf inhaled KL4 surfactant that is already underway. The company had previously received $580,000 of the Fast Track Small Business Innovation Research (SBIR) grant, which it used for development of its … [Read more...] about Discovery Labs gets $1.9 million for Aerosurf development
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Positive Phase 3 results for Incruse Ellipta plus Breo/Relvar Ellipta
GlaxoSmithKline and Theravance have announced that two Phase 3 studies have shown that COPD patients using the Incruse Ellipta umeclidinium (UMEC) DPI in conjunction with the Breo/Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI achieved a statistically significant greater improvement in FEV1 compared to patients using Breo/Relvar plus a placebo. A total … [Read more...] about Positive Phase 3 results for Incruse Ellipta plus Breo/Relvar Ellipta
AstraZeneca licenses inhaled interferon beta from Synairgen
AstraZeneca has paid $7.25 million up-front with potential milestone payments of up to $225 million for a global licence from Synairgen for its SNG001 inhaled interferon beta for the treatment of viral respiratory tract infections in severe asthma patients. The agreement also includes royalties "ranging from single-digit up to mid-teens" for commercial sales, and … [Read more...] about AstraZeneca licenses inhaled interferon beta from Synairgen
OptiNose announces senior management additions
OptiNose has announced three hires for senior management positions, which it says "will help drive the company forward in its mission to introduce new and valuable treatment options to the market utilizing its novel Bi-Directional Breath Powered Delivery Technology." The company has hired Ramona Lloyd as VP, Regulatory Affairs & Quality; Sheila Bergey as VP, … [Read more...] about OptiNose announces senior management additions
FDA approval for single-dose Nascobal cyanocobalamin nasal spray
Strativa Pharmaceuticals has announced that it has received FDA approval for its disposable single-dose device version of Nascobal cyanocobalamin nasal spray for the treatment of pernicious anemia and other vitamin B12 deficiencies. The new product will be available in September 2014 and will replace the current multi-dose product. Strativa Senior VP Brand Sales … [Read more...] about FDA approval for single-dose Nascobal cyanocobalamin nasal spray
Pharmaterials planning dedicated inhalation development lab as part of major expansion
CDMO Pharmaterials has announced that it will quadruple its GMP manufacturing capacity and add a dedicated inhalation development laboratory as part of an expansion of its Reading, UK site. The expansion plans also include additions to existing analytical and stability facilities to support increased manufacturing, both for clinical trial and commercial … [Read more...] about Pharmaterials planning dedicated inhalation development lab as part of major expansion
Positive Phase 3 results for Avanir’s intranasal sumatriptan
Avanir Pharmaceuticals and OptiNose have announced that a Phase 3b trial demonstrated that acute migraine patients experienced greater pain relief within 30 minutes of dosing using Avanir's AVP-825 intranasal sumatriptan powder than patients taking sumatriptan 100mg tablets. In addition, a greater percentage of patients using AVP-825 were free of pain at 15 minute … [Read more...] about Positive Phase 3 results for Avanir’s intranasal sumatriptan
Grifols makes $5 million milestone payment to Aradigm as Pulmaquin Phase 3 trial begins
Aradigm has received a $5 million milestone payment from Grifols as the ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial of Pulmaquin inhaled ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis gets underway, the company announced. In May 2013, Grifols paid $25 million upfront to license Aradigm's inhaled ciprofloxacin … [Read more...] about Grifols makes $5 million milestone payment to Aradigm as Pulmaquin Phase 3 trial begins
FDA clearance for new Smartinhaler system
According to Smartinhaler manufacturer Nexus6, the FDA has granted 510(k) marketing clearance for a new version of the inhaler monitoring system called SmartTouch. The system includes a touch screen on the monitoring device and is available for a number of different MDIs, including Ventolin, Advair (Seretide), and Dulera. Nexus6 CEO Garth Sutherland commented, … [Read more...] about FDA clearance for new Smartinhaler system
Parion announces management changes
Parion Sciences, which is developing a trans-nasal aerosol delivery system and several products for cystic fibrosis, has announced several changes to its executive team. Paul Boucher, previously VP of Finance & Business has been promoted to President; Joe Schachle, previously Head of Global Marketing Operations at Grifols, has been hired as Chief Operating Officer; … [Read more...] about Parion announces management changes