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On April 26, 2013, the FDA approved Teva’s Abbreviated New Drug Application for levalbuterol inhalation solution, its generic version of Sunovion’s Xopenex. Teva is offering three strengths: 0.31 mg, 0.63 mg, and 1.25 mg. The… Read more . . .
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Almirall and Forest Labs have announced positive results from the Phase 3 AUGMENT/COPD study of their fixed dose combination aclidinium bromide/formoterol fumarate dry powder inhaler in patients with COPD. The announcement followed several weeks after… Read more . . .
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According to GlaxoSmithKline, the company has submitted an application to the FDA for umeclidinium bromide (UMEC) administered using the Ellipta DPI for the treatment of COPD. The filing comes just days after GSK announced the… Read more . . .
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Trimel Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA regarding its CompleoTRT bioadhesive intranasal gel testosterone for the treatment of testosterone deficiency in men. According to the company, the intranasal gel is… Read more . . .
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The 19 member companies of the Medicon Valley Inhalation Consortium (MVIC) have announced the creation of a single company called MVIC AB in order to simplify customer relationships with the organization. Orest Lastow of Zenit… Read more . . .
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Israeli/American biotech company Andain Inc. says that it has developed an “innovative lipid-based drug delivery nano-particles capable of carrying hydrophilic and hydrophobic drugs to a targeted human organ with timely drug release capabilities” and announced… Read more . . .
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GlaxoSmithKline says that it has submitted a Marketing Authorisation Application (MAA) to the EMA for umeclidinium bromide (UMEC) monotherapy to be delivered using the Ellipta DPI for the treatment of COPD. UMEC is a long-acting… Read more . . .
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The board of directors of Theravance, Inc. has decided to split the organization into two separate companies by late 2013 or early 2014 in a move “designed to unlock potential value, facilitate return of capital… Read more . . .
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Novartis’s QVA149 indacaterol maleate/glycopyrronium DPI demonstrated 15% greater reduction in all COPD exacerbations compared to glycopyrronium and 14% compared to tiotropium according to study results published April 23 2013 in Lancet Respiratory Medicine. QVA149 reduced… Read more . . .
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GlaxoSmithKline and Theravance have submitted an application for the Anoro Ellipta umeclidinium bromide /vilanterol (UMEC/VI) DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare (MHLW), the companies said. The… Read more . . .
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