August 2012
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Glenmark Pharmaceuticals Europe said that its marketing authorization application for a generic version of Seretide Accuhaler (Advair Diskus) for the treatment of asthma and COPD has been approved through the decentralized procedure in the Nordic… Read more . . .
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Aradigm has announced that the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) will meet on January 11, 2018 to review the NDA for Linhaliq inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis… Read more . . .
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Airware Labs Corporation has entered into a non-binding letter of intent to acquire a cannabis consulting company and grower doing business as Item 9 Labs with the goal of developing an intranasal THC product, Airware… Read more . . .
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Savara has received a development award of up to $5 million from Cystic Fibrosis Foundation Therapeutics (CFFT), which will support the Phase 3 AVAIL study of the AeroVanc DPI for the treatment of MRSA lung… Read more . . .
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Novartis has announced that the FLASH study met its primary endpoint, demonstrating that switching COPD patients from Seretide (Advair) salmeterol/fluticasone Ultibro Breezhaler (Utibron Neohaler) indacaterol/glycopyrronium significantly improved lung function. The safety and tolerability of both… Read more . . .
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Bayer has announced the failure of the Phase 3 INHALE study of Amikacin Inhale inhalation solution for the treatment of gram-negative pneumonia in intubated and mechanically ventilated patients with Gram-negative pneumonia to demonstrate superiority in… Read more . . .
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GlaxoSmithKline and Innoviva have announced the submission of a supplemental New Drug Application for broader use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for COPD based on data from the IMPACT study. Trelegy Ellipta was initially… Read more . . .
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Kamada has announced that an agreement with Chiesi for European distribution of Kamada’s inhaled Alpha-1 Antitrypsin (AAT) has been terminated. According to Kamada, the companies mutually agreed to end the agreement because Kamada recently withdrew… Read more . . .
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According to Cipla, the company’s ANDA for generic budesonide inhalation suspension has been approved by the FDA for the treatment of asthma in children aged 12 months to 8 years. Cipla will market the generic… Read more . . .
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The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) met on November 16, 2017 to consider Bayer HealthCare’s NDA for ciprofloxacin inhalation powder for the reduction of exacerbations in non-cystic fibrosis bronchiectasis patients who have bacterial lung… Read more . . .
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