During its second quarter earnings call on July 24, 2018, Eli Lilly announced that it had filed regulatory submissions with the FDA and with the EMA for its intranasal glucagon for the treatment of severe hypoglycemia in diabetes patients taking insulin. Lilly acquired worldwide rights to the nasal glucagon powder from Locemia in 2015. The MAA was submitted under … [Read more...] about Eli Lilly submits NDA, MAA for intranasal glucagon
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Tanner Pharma Group subsidiary to distribute Afrezza inhaled insulin outside of US
MannKind Corporation has signed an agreement with Tanner Pharma Group for distribution of Afrezza inhaled insulin in regions outside of the US, the company said. The agreement covers regions where Afrezza is not yet approved, and Tanner Pharma Group subsidiary TannerGAP will manage the distribution in those areas. In 2017, Mannkind announced that Biomm would … [Read more...] about Tanner Pharma Group subsidiary to distribute Afrezza inhaled insulin outside of US
Savara acquires rights to inhaled antibiotic, appoints new strategic advisor, and provides update on Molgradex development
Savara has acquired rights to an amikacin/fosfomycin inhalation solution that was being developed by Cardeas Pharma for the treatment of ventilator associated pneumonia and has appointed former Cardeas Pharma CEO A. Bruce Montgomery as a strategic advisor, the company said. The company also announced a public offering of common stock, with shares priced at $11.50 … [Read more...] about Savara acquires rights to inhaled antibiotic, appoints new strategic advisor, and provides update on Molgradex development
Adherium gets additional 510(k) clearance for OTC sales of Hailie inhaler monitoring sensor
According to Adherium, the FDA has granted 510(k) clearance for OTC sales of the company's Hailie adherence monitoring sensor for use with several MDIs for the treatment of asthma. In March 2018, the FDA granted 510(k) clearance for OTC sales of the sensor for use with Symbicort; the new clearance covers use with ProAir HFA, Ventolin HFA, and Flovent HFA. The … [Read more...] about Adherium gets additional 510(k) clearance for OTC sales of Hailie inhaler monitoring sensor
Igor Gonda: Cloud medicine is not just a pie in the sky for OINDPs
I am sure that I was not alone to conclude after the 2018 Respiratory Drug Delivery Conference that the most profoundly important session was “Exploring the Benefits of Smart Inhalers on Public Health.” And I immediately thought about the ambitions we had at Aradigm Corporation for our SmartMist device – the first “electronic inhaler.” Smartmist was really smart: … [Read more...] about Igor Gonda: Cloud medicine is not just a pie in the sky for OINDPs
Clinical development program for Penthrox put on hold
After meeting with the FDA regarding the clinical program for US approval of its Penthrox methoxyflurane inhaler, Medical Developments International (MVP) said that it expects to receive a clinical hold letter from the agency within the next two months. Penthrox is currently approved for the treatment of pain in numerous countries, including Canada, and much of … [Read more...] about Clinical development program for Penthrox put on hold
Copley Scientific introduces upgraded NGI Assistant for inhaler testing
Copley Scientific has announced the launch of an upgraded NGI Assistant for automated drug recovery from NGI cascade impactors for inhaler testing. According to Copley, the new model features a simplified interface and shorter cycle times compared to the previous model. The NGI Assistant automatically dispenses solvent into up to 3 NGI cup trays at a time, … [Read more...] about Copley Scientific introduces upgraded NGI Assistant for inhaler testing
FDA reopens comment period for draft guidance on MDI and DPI quality considerations
The FDA has issued a notice that it has reopened the comment period for the “Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry,” which was published in April, 2018. The FDA originally gave interested parties until June 18, 2018 to submit input; the comment period has now been extended until September 18, … [Read more...] about FDA reopens comment period for draft guidance on MDI and DPI quality considerations
Windtree Therapeutics to use upgraded aerosol delivery system for Phase 3 studies
Windtree Therapeutics said that it has completed design verification of a new version of its aerosol delivery system (ADS) for Aerosurf inhaled KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants and plans to use the new system in Phase 3 studies of the drug. The company said that Mack Medical is preparing to manufacture the … [Read more...] about Windtree Therapeutics to use upgraded aerosol delivery system for Phase 3 studies
Nanopharm partners with Sciarra Laboratories to provide CDMO services for MDIs
Nanopharm Limited has announced an agreement with US-based Sciarra Laboratories that will pair Nanopharm's SmartTrack OINDP development services with Sciarra's GMP metered dose inhaler manufacturing services. Together, Nanopharm and Sciarra will comprise a CDMO with more than 30,000 square feet of research and manufacturing space, which the companies say "offers … [Read more...] about Nanopharm partners with Sciarra Laboratories to provide CDMO services for MDIs