News
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Sunovion has launched the Utibron Neohaler indacaterol/glycopyrrolate DPI for the treatment of COPD in the United States, the company announced. Sunovion acquired the US rights to the Utibron, Seebri, and Arcapta Neohalers from Novartis in… Read more . . .
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Verona Pharma has announced a clinical development services agreement with QuintilesIMS for Verona’s RPL554, an inhaled PDE3/PDE4 inhibitor for the treatment of acute exacerbations in COPD patients. The company also said that it is planning… Read more . . .
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Judge Richard G. Andrews of the US District Court, District of Delaware, has found that Lannett has infringed on the US patents 6,750,237 and 7,220,767 related to Zomig zolmitriptan nasal spray, Impax Laboratories has announced.… Read more . . .
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Capsugel has added a new Harro Hӧfliger Modu-C MS encapsulation unit with a capacity of over 72,000 capsules per hour for late-stage clinical trial and commercial production of dry powder inhaler formulations, the company said.… Read more . . .
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Mylan has announced that it received a complete response letter from the FDA in regards to its ANDA for a generic version of GlaxoSmithKline’s Advair Diskus fluticasone/salmeterol DPI. The company said that it is reviewing… Read more . . .
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Glenmark Pharmaceuticals says that data from a Phase 3 study of its GSP 301 mometasone furoate/olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis show statistically significant and clinically meaningful improvement in symptoms… Read more . . .
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The FDA has denied a citizen petition filed by Sandoz in October 2016 in which Sandoz challenged the agency’s 2013 bioequivalence recommendations for generic versions of Advair Diskus fluticasone propionate/salmeterol xinafoate. However, in a copy… Read more . . .
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Lupin announced that the FDA has granted final approval for the company’s tobramycin inhalation solution, a generic version of Novartis’s TOBI 300 mg/5 ml inhalation solution for the treatment of P. aeruginosa lung infections in… Read more . . .
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Opiant Pharmaceuticals (formerly Lightlake Therapeutics) has announced the initiation of a Phase 2 trial of its OPNT001 intranasal naloxone for the treatment of bulimia nervosa. In 2014, the company licensed its Narcan intranasal naloxone for… Read more . . .
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The Monash University Institute of Pharmaceutical Sciences (MIPS) has announced positive results from a Phase 1 study of inhaled oxytocin in healthy volunteers. The study was conducted by GSK, which is partnered with Monash University… Read more . . .
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