December 2016
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According to Adherium, the FDA has okayed over-the-counter (OTC) sales of the company’s Smartinhaler sensor for AstraZeneca’s Symbicort MDI. The 510(k) OTC clearance will allow patients to purchase the sensor without a prescription at local… Read more . . .
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Evoke Pharma announced that an amendment of its agreement with Mallinckrodt allows for deferral of milestone payments due on acceptance of review of the company’s NDA for Gimoti intranasal metoclopramide for the treatment of gastroparesis… Read more . . .
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Acorda Therapeutics has submitted a marketing authorization application to the EMA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson’s disease patients, the company said. The application is supported by data… Read more . . .
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Hovione has provided an update on its ongoing expansion of manufacturing sites in Portugal, Ireland and the US, saying that it has already added significant capacity to the Portuguese and US facilities and has plans… Read more . . .
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Orion Corporation has announced that its salmeterol/fluticasone Easyhaler combination DPI has received a positive opinion under the EU’s decentralized procedure, with Sweden as the reference member state. Orion had announced in December 2016 that it… Read more . . .
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According to an article published March 15, 2018 in the Journal of Psychopharmacology, a pilot trial of intranasal ketamine for the treatment of severe depression conducted by researchers from the University of New South Wales… Read more . . .
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Savara, which just announced the discontinuation of its Aironite development program after the failure of a Phase 2 trial to meet its endpoint, says that it has initiated a Phase 2a clinical study of Molgradex… Read more . . .
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Windtree Therapeutics and Eleison Pharmaceuticals will jointly evaluate the feasibility of delivering Eleison’s inhaled lipid cisplatin (ILC) for the treatment of lung cancer via Windtree’s proprietary pulmonary aerosol delivery system (ADS), the companies said. A… Read more . . .
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Copley Scientific has announced the appointment of an experienced lean manufacturing consultant, Richard Postlethwaite, as Chief Operating Officer. Postlethwaite was most recently Senior Operations Manager of Walgreens Boots Alliance and previously held a number of… Read more . . .
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UK-based Avillion announced that it has signed a deal with AstraZeneca subsidiary Pearl Therapeutics for development of Pearl’s PT027 budesonide/albuterol MDI for the treatment of asthma. Avillion will finance clinical development and the regulatory submission.… Read more . . .
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