News
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Norwegian CDMO Curida, which offers a wide range of analytical, development, and manufacturing services for OINDPs, has announced a new strategic partnership with pharmAccel Consulting Director René Bommer. In July 2015, Curida acquired a nasal… Read more . . .
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Adapt Pharma has announced the availability of Narcan naloxone hydrochloride nasal spray for the treatment of opioid overdose in the US. Narcan nasal spray was approved by the FDA in November 2015. In 17 of… Read more . . .
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Health Canada has approved Teva Canada Limited’s application for its tobramycin inhalation solution, a generic version of Novartis’s TOBI inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients in Canada. The… Read more . . .
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Propeller Health and Aptar Pharma have teamed up to develop a connected MDI that features an integrated sensor and an electronic dose counter. The companies say that they expect to begin clinical studies with the… Read more . . .
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Laboratory automation company Astech Projects has been acquired by German holding company the Schauenburg International Group. Astech Projects manufactures the Xelair, Xelize, and Xelox ranges of automated inhaler testing systems and offers systems for nasal… Read more . . .
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The FDA published notices on February 16, 2016 announcing publication of draft guidances titled “Allergic Rhinitis: Developing Drug Products for Treatment” and “Nonallergic Rhinitis: Developing Drug Products for Treatment. The agency says that comments should… Read more . . .
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Lannett Company has received FDA approval for its sumatriptan nasal spray, a generic version of GSK’s Imitrex nasal spray. The company cites IMS statistics showing that US sales of sumatriptan nasal spray totaled $62 million… Read more . . .
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The FDA has accepted Mylan’s abbreviated new drug application for its generic fluticasone propionate/salmeterol DPI and has set a GDUFA goal date of March 28, 2017, the company said. Mylan filed the ANDA for the… Read more . . .
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MannKind Corporation has announced the resignation of Alfred Mann as Executive Chairman and the appointment of Kent Kresa as Chairman of the Board, effective immediately. Mann will continue as a non-executive advisor, the company said.… Read more . . .
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Serendex Pharmaceuticals has announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved the company’s planned IMPALA Phase 2/3 clinical trial of Molgradex inhaled molgramostim for pulmonary alveolar proteinosis (PAP). According to the… Read more . . .
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