News
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Express Scripts, a pharmacy benefit manager (PBM) that administers prescription drug programs for more than 100 million Americans, has announced the exclusion of more than a dozen popular OINDPs from its 2014 national preferred drug… Read more . . .
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The United States Patent and Trademark Office (USPTO) has issued Civitas Therapeutics US Patent No. 8,545,878, with an expiration date of November 16, 2032, for a patent titled “Capsules containing high doses of levodopa for… Read more . . .
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Bend Research has announced a $20+ million expansion of its commercial spray drying capacity, including a new commercial manufacturing facility with two PSD spray dryer process trains. The company expects completion and validation of the… Read more . . .
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In a November 5, 2013 interview on CNBC, Acorda CEO Ron Cohen announced that the company has filed a regulatory application to the FDA for its diazepam nasal spray for the treatment of epilepsy. Acorda… Read more . . .
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Novartis has announced that “it will initiate consultation on proposals to close” its respiratory R&D center in Horsham, UK. According to Novartis, the potential closing will affect “up to 371 roles” at the site, plus… Read more . . .
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The US FDA has issued a warning letter to Sunovion regarding claims made in four patient brochures aimed respectively at COPD patients currently using MDIs, DPIs, nebulized short acting beta agonists, or any medication giving… Read more . . .
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Copley Scientific‘s new TPK-R critical flow controller is designed specifically to connect to the right-hand outlet of NGI cascade impactor, allowing for efficient use of bench space, the company says. The TPK-R is a mirror… Read more . . .
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Health Canada has approved Almirall’s Tudorza Genuair aclidinium bromide DPI for the treatment of COPD, Almirall Canada has announced. Forest Laboratories is partnered with Almirall on commercialization of the product in Canada and in the… Read more . . .
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GlaxoSmithKline and Theravance have announced the availability of the Breo Ellipta fluticasone furoate/vilanterol DPI in the US. The FDA approved Breo Ellipta for the treatment of COPD in May 2013. The launch triggers a $30… Read more . . .
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MannKind, which resubmitted its NDA for Afrezza inhaled insulin earlier this month, has announced that, “The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in… Read more . . .
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