News
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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… Read more . . .
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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… Read more . . .
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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reopened the comment period for the “Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry,” which was published in April, 2018.… Read more . . .
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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… Read more . . .
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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… Read more . . .
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Pneuma Respiratory, which is developing a digital soft mist inhaler, announced that it has completed a Series A financing round that raised $8.3 million. The company’s Pneumahaler device is a breath activated digital SMI that… Read more . . .
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Pulmatrix has announced that the 3rd part of its Phase 1/1b study of Pulmazole (PUR1900) itraconazole DPI for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma has been completed and “successfully achieved… Read more . . .
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3M Drug Delivery Systems has announced that its Proventil HFA albuterol MDI, which is marketed and distributed by Merck, now includes a top-mounted dose indicator. The FDA approved an sNDA for Proventil HFA with the… Read more . . .
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Intranasal drug developer Impel NeuroPharma has hired Lynn C. Gold as Senior VP of Regulatory Affairs, the company said. Gold was most recently VP of Scientific and Regulatory Affairs at Camargo Pharmaceutical Services and had… Read more . . .
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According to reports, Montenegrin pharmaceutical company Hemomont has officially opened a €5.3 million, 1,700 square meter nasal spray manufacturing facility in Podgorica that is expected to employ 30 people and produce 3 million units per… Read more . . .
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