December 2016
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The Drug Delivery to the Lungs conference organizing committee and the British Thoracic Society have both announced that they will cut ties with inhalation CDMO Vectura following the company’s acquisition by tobacco company Philip Morris… Read more . . .
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Pulmocide announced that the FDA has granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations for its PC945 inhaled opelconazole for the treatment of invasive pulmonary aspergillosis (IPA). Pulmocide launched in 2013 to… Read more . . .
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The EMA and the FDA have launched a pilot program in which the agencies will give parallel scientific advice (PSA) to applicants submitting MAAs for hybrid products and ANDAs for complex generic products, including inhalers… Read more . . .
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Dutch vaccine developer Intravacc has announced that it will continue to develop its pipeline of intranasal vaccines while adding a contract development and manufacturing business. The company said that it will offer GMP manufacturing for… Read more . . .
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Kinaset Therapeutics said that dosing is underway in a Phase 1b SAD/MAD study of its KN-002 dry powder JAK inhibitor, which it is developing for the treatment of asthma and COPD. The trial is expected… Read more . . .
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Theravance Biopharma said that it expects to cut 270 jobs, or 75% of its current workforce, by February 2022 and that it will stop development of candidates outside of its respiratory portfolio. The announcement came… Read more . . .
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VistaGen Therapeutics said that it has initiated the PALISADE-2 Phase 3 clinical trial of its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). The company initiated the PALISADE-1 trial of PH94B… Read more . . .
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According to Adherium, the company has received 510(k) clearance from the FDA for its next generation Hailie inhaler sensor. The new version of the Hailie sensor, which is meant to be used with the Symbicort… Read more . . .
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AstraZeneca has announced that the Phase 3 MANDALA and DENALI trials of PT027 albuterol (salbutamol)/budesonide MDI for the treatment of asthma both met their primary endpoints. The company has been co-developing PT027 with Avillion since… Read more . . .
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Nanoform Finland and Herantis Pharma say that they have successfully demonstrated the feasibility of using Nanoform’s nanoparticle technology for a potential intranasal formulation of Herantis’s cerebral dopamine neurotrophic factor (CDNF) for the treatment of Parkinson’s disease,… Read more . . .
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