MannKind, which resubmitted its NDA for Afrezza inhaled insulin earlier this month, has announced that, "The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014." The FDA goal is to "Review and act on 90 percent of Class 2 resubmitted original … [Read more...] about MannKind gets PDUFA date for Afrezza
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Bend Research adds Xcelodose micro-dosing system
Bend Research has added an Xcelodose 600S powder micro-dosing system, the company said, allowing it to fill capsules for inhalation development projects with low dose weights. The company notes that, "Precision capsule fill capability is imperative for dry powder inhalation drug products." Bend was recently acquired by Capsugel, which manufactures the Xcelodose line. … [Read more...] about Bend Research adds Xcelodose micro-dosing system
Management changes at Presspart
MDI component manufacturer Presspart has announced a round of changes to its management team. According to the company, Hans Neugebauer, who is currently Managing Director of Presspart Marsberg, will become Managing Director of Presspart Blackburn as of January 1, 2014. At that time, Dietmar Schmitz will return to his former position as the Presspart group Chief … [Read more...] about Management changes at Presspart
Milestone initiates Phase 1 trial of intranasal calcium channel antagonist
Canadian cardiovascular drug development company Milestone Pharmaceuticals has initiated a Phase 1 clinical trial of its lead product, MSP-2017 intranasal short-acting calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia (PSVT), the company announced. The randomized, double-blind, placebo-controlled crossover study will take place in … [Read more...] about Milestone initiates Phase 1 trial of intranasal calcium channel antagonist
Depomed launches Lazanda fentanyl nasal spray with patient support program
Depomed has announced a new launch of Lazanda fentanyl nasal spray in the US for the management of breakthrough pain in cancer patients who get inadequate relief from opioids. The company acquired the product from Archimedes in July 2013. Depomed is offering a new patient support system for the drug that is "designed to streamline patient access" and that includes … [Read more...] about Depomed launches Lazanda fentanyl nasal spray with patient support program
GSK submits NDA for fluticasone furoate DPI
According to GlaxoSmithKline, the company has submited a new drug application (NDA) to the US FDA for a once-daily fluticasone furoate (FF) dry powder inhaler for the treatment of asthma. The NDA is for 100mcg and 200mcg doses of FF delivered by the Ellipta DPI. The FDA approved GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment … [Read more...] about GSK submits NDA for fluticasone furoate DPI
Adasuve inhaled loxapine launched in Austria
Alexza Pharmaceuticals and Grupo Ferrer have launched Adasuve loxapine inhalation powder for the treatment of agitation in schizophrenic patients in Austria, the companies said. Ferrer is working with Vienna-based AOP Orphan Pharmaceuticals to commercialize Adasuve in Austria. Alexza President and CEO Thomas B. King commented, "With the launch of Adasuve in … [Read more...] about Adasuve inhaled loxapine launched in Austria
Settlement in Accuhale suit against AstraZeneca
Acacia Research has announced a settlement in its patent infringement suit against AstraZeneca. The suit, Accuhale vs. AstraZeneca, was filed in December 2011, shortly after Acacia announced that it had acquired patents for inhaler technology from “a major medical company.” No terms were disclosed. The suit claimed that AstraZeneca's Symbicort pMDI infringed on US … [Read more...] about Settlement in Accuhale suit against AstraZeneca
Puget Technologies says it will develop intranasal cannabinoids
Florida-based Puget Technologies has announced that its subsidiary Cannabis Biotech has initiated a research project to develop an intranasal formulation of cannabinoids, saying that the "project is targeted towards those who desire the benefits of medical marijuana but do not want the harmful effects or stigma of smoking it." The company said that the project will be … [Read more...] about Puget Technologies says it will develop intranasal cannabinoids
Coster to provide MDI filling line for Catalent
Aerosol component and filling specialist Coster has announced that it will develop and construct a 150 can/minute MDI filling line for Catalent Pharma Solutions's Inhalation Center of Excellence in Research Triangle Park, NC. Catalent announced a $20 million expansion of its inhalation capabilities at the RTP center in January 2013. According to Coster, the line will … [Read more...] about Coster to provide MDI filling line for Catalent