News
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The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) met on November 16, 2017 to consider Bayer HealthCare’s NDA for ciprofloxacin inhalation powder for the reduction of exacerbations in non-cystic fibrosis bronchiectasis patients who have bacterial lung… Read more . . .
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Propeller Health has partnered with US pharmacy benefits manager Express Scripts to provide Propeller’s inhaler monitoring platform to asthma and COPD patients enrolled in Express Scripts’ Pulmonary Care Value Program. According to the companies, patients… Read more . . .
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The European Commission has approved GSK’s marketing authorization application for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD, the company said. The EMA Committee for Medicinal Products for Human Use (CHMP) had issued… Read more . . .
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CDMO Pharmaterials, which offers a wide range of development and manufacturing services for inhaled drugs, has been acquired by Quotient Sciences, Quotient said. Pharmaterials was previously owned by PII, which acquired the company in 2008.… Read more . . .
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Innovus Pharmaceuticals says that it has launched FlutiCare fluticasone propionate nasal spray over the counter in the US in independent pharmacies and through its own online sites, as well as through Amazon and Walmart online… Read more . . .
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Theravance Biopharma and Mylan have submitted an NDA to the FDA for revefenacin inhalation solution (TD-4208) for the treatment of COPD, the companies said. Theravance and Mylan announced their partnership on the development of nebulized… Read more . . .
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Copley Scientific has announced the availability of 2 new breath simulators, the BRS 2100 and BRS 3100, that can generate patient-derived breathing profiles for inhaler and nebulizer testing in addition to the pharmacopeoeial standard breathing… Read more . . .
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Evoke Pharma has announced that has signed a 5-year agreement with CDMO Patheon for commercial manufacturing of Evoke’s Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis. Patheon was acquired by Thermo Fisher earlier this… Read more . . .
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The Japan Patent Office has allowed JP Application No. 2014-515967 which covers Neurelis’ NRL-1 intranasal diazepam formulation, the company said. In January 2017, Neurelis received Fast Track designation from the US FDA for NRL-1, which… Read more . . .
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Novoclem Therapeutics says that its BIOC51 inhaled antimicrobial has received Qualified Infectious Disease Product (QIDP) designation from the FDA. The company says that BIOC51 could be delivered as either a dry powder or as an… Read more . . .
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