News
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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The FDA has issued dozens of new product-specific draft guidances for generic drug development, including a draft guidance for dry powder formulations of albuterol sulfate.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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Mylan said that the company is paying approximately $463 million to Novartis for worldwide rights to TOBI Podhaler tobramycin DPI and TOBI tobramycin inhalation solution. Approximately $240 million of that amount will be paid in… Read more . . .
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Biohaven Pharmaceuticals said that it has filed an investigational new drug application for its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist, which it is developing for the prevention and treatment of migraine. BHV-3500, which… Read more . . .
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Vectura has announced that revenues from inhaled drugs rose 7.1% in the first half of 2018, with Flutiform revenues up 3.1% compared to the first half of 2017 and up 6.1% compared to the second… Read more . . .
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According to Mundipharma, Napp Pharmaceuticals has launched the company’s Flutiform fluticasone propionate/formoterol fumarate k-haler breath-activated MDI in the UK. The launch is the first in Europe since Flutiform k-haler was approved for the treatment of… Read more . . .
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