December 2016
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DPI developer TFF Pharmaceuticals has received a communication from the European Patent Office (EPO) in regards to its patent application No. 08771657.7 “Formation of Stable Submicron Peptide or Protein Particles by Thin Film Freezing,” giving… Read more . . .
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According to Neurelis, the company has submitted an NDA for its diazepam nasal spray, now called Valtoco, for the treatment of cluster seizures in epilepsy patients aged six years and older. The nasal spray, previously… Read more . . .
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According to Senzer, a PK study conducted by Insys Therapeutics found that a 0.35 mg dose of dronabinol delivered by Senzer’s Voke inhaler achieved a similar maximum concentration as a 5.0 mg dose of Marinol… Read more . . .
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Just weeks after Janssen announced that it had submitted an NDA for its intranasal esketamine for the treatment of depression, the company has presented data from a Phase 3 trial of the nasal spray that… Read more . . .
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According to GlaxoSmithKline and Innoviva, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding wider use of the Trelegy Ellipta fluticasone furoate/umeclidinium/ vilanterol DPI in moderate-to-severe COPD. Trelegy… Read more . . .
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Dance Biopharm announced that the company completed a private equity financing round that raised $24.5 million that included participation by Molex Ventures, an electronics company that is involved in development of the Dance 501 connected… Read more . . .
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Roivant, which recently acquired Patara Pharma’s cromolyn sodium inhalation solution for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), has launched a company called Respivant to develop the drug. The new… Read more . . .
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VistaGen Therapeutics has acquired exclusive global rights to PH94B aloradine nasal spray, which Pherin Pharmaceuticals has been developing for the treatment of social anxiety disorder (SAD), the company said. A Phase 3 study of PH94B… Read more . . .
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Acorda Therapeutics has announced that the PDUFA date for review of its NDA for the Inbrija levodopa DPI for the treatment of symptoms during OFF periods in Parkinson’s disease patients has been changed from October… Read more . . .
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The FDA has issued dozens of new product-specific draft guidances for generic drug development, including a draft guidance for dry powder formulations of albuterol sulfate. The guidance covers development of generic equivalents to Teva’s ProAir… Read more . . .
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