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The FDA has designated the established name for Insmed’s inhaled amikacin, which is in Phase 3 development for the treatment of nontuberculous mycobacteria (NTM) lung infections, as “amikacin liposome inhalation suspension,” the company said in… Read more . . .
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Endo Pharmaceuticals filed suit against Lupin on July 28, 2017 alleging infringement of patents related to Par’s Nascobal cyanocobalamin nasal spray. The suit was filed in the United States District Court for the Eastern District… Read more . . .
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Milestone Pharmaceuticals has raised $55 million in a Series C financing round led by Novo Holdings A/S, the company said. The company plans to use the money to fund Phase 3 clinical development of etripamil,… Read more . . .
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According to Indivior, the French regulatory agency Agence nationale de sécurité du médicament et des produits de santé (ANSM) has approved the company’s MAA for Nalscue naloxone hydrochloride nasal spray for the reversal of opioid… Read more . . .
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CDMO Aptuit, which provides inhaled drug development and clinical supply manufacturing services, will be acquired by German CRO Evotec for $300 million, the two companies have announced. Aptuit has about 750 employees at 3 sites… Read more . . .
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Theravance Biopharma has announced the appointment of former Roche Partnering VP Shehnaaz Suliman as Senior VP, Corporate Development and Strategy. Theravance Biopharma Chairman and CEO Rick E. Winningham commented, “We are thrilled to add an… Read more . . .
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Aradigm Corporation has filed a new drug application to for Linhaliq inhaled ciprofloxacin (formerly Pulmaquin) for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE), the company said. The company… Read more . . .
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GSK has filed a supplementary NDA for approval of a 50mcg once-daily dose of the Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11. The FDA approved 100mcg and 200mcg… Read more . . .
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Samumed’s SM04646 inhaled Wnt pathway inhibitor has been granted orphan drug designation by the FDA, the company has announced. The company recently announced positive Phase 1 results for SM04646, which it is developing for the… Read more . . .
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GlaxoSmithKline and Innoviva have announced the filing of a submission to the EMA for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI (marketed as Breo Ellipta in the US) by patients whose asthma is… Read more . . .
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