News
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According to Pharmaxis, treatment has been concluded in a Phase 3 trial of its Bronchitol mannitol DPI for the treatment of cystic fibrosis. A total of 423 patients in 21 countries were treated in the… Read more . . .
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Adapt Pharma has filed a marketing authorization application in Europe for its naloxone nasal spray for the treatment of opioid overdose, the company said. Adapt’s naloxone nasal spray, marketed as Narcan, has been approved in… Read more . . .
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For RDD Europe 2017, to be held April 25-28, 2017 at the Palais des Congrès in Antibes, France, organizers RDD Online and Aptar Pharma expect approximately 450 OINDP experts to attend the 3-day conference. Two… Read more . . .
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Vectura met the £9 million calendar year royalty cap on GSK’s Ellipta DPI products in 2016, a year earlier than predicted, the company said. The £9 million calendar year royalty cap is included in a… Read more . . .
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Dauntless Pharmaceuticals has initiated a Phase 1 clinical study of its DP1038 intranasal octreotide acetate, the company said. The study will compare DP1038 to Sandostatin octreotide acetate injection in healthy volunteers. DP1038 is in development… Read more . . .
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Windtree Therapeutics says a pre-clinical study in ferrets exposed to influenza demonstrated that the company’s aerosolized KL4 surfactant increased survival and reduced lung inflammation, although the increase in survival rate was less than that for… Read more . . .
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The FDA has approved Boehringer Ingelheim’s sNDA for the use of Spiriva Respimat to treat asthma in patients aged 6 and older and has granted pediatric exclusivity for the product, the company announced. Spiriva Respimat… Read more . . .
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Evoke Pharma has announced that the FDA will allow the company to move forward with an NDA for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis without a human factors validation study,… Read more . . .
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Using morphologically-directed Raman spectroscopy (MDRS) for generic nasal spray development. Q:Last year, the FDA published an article titled “The FDA Embraces Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays” in which the FDA’s… Read more . . .
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Prevacus has announced that it plans to initiate a Phase 1 clinical trial of its PRV-002 intranasal product for the treatment of mild traumatic brain injury (mTBI) by the middle of 2017. According to the… Read more . . .

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