August 2012
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The EC has granted marketing authorization to Insmed’s Arikayce nebulized lipsomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adult patients without cystic fibrosis who have limited treatment… Read more . . .
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Ampio Pharmaceuticals has announced the initiation of a Phase 1 trial of an inhaled formulation of its Ampion anti-inflammatory biologic; the company had announced plans for the trial in September 2020 after having said in… Read more . . .
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According to ATAI Life Sciences, the FDA has cleared an IND submitted by Neuronasal Inc. for its N-acetylcysteine (NAC). In January 2020, ATAI announced that it had partnered with Neuronasal on development of intranasal NAC… Read more . . .
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CDMO Experic is adding a thin film freezing manufacturing line based on technology owned by TFF Pharmaceuticals at its Cranbury, NJ, USA cGMP facility, according to TFF. Completion of Experic’s TFF line, which adds a… Read more . . .
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According to Proveris Scientific, Lynn Jordan has joined the company as Applications Laboratory Manager. Proveris offers laboratory services for development and analysis of a wide range of OINDPs, and the company launched new cGMP compliant… Read more . . .
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Lonza has announced that it will invest CHf 85 million (~$94 million) at 8 of its Capsugel manufacturing sites around the world to expand its capsule manufacturing capacity by 15%, or 30 billion capsules per… Read more . . .
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According to AstraZeneca, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s Trixeo Aerosphere formoterol fumarate/ glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to… Read more . . .
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CDMO Arcinova has added a 3P Innovation R1000 micro-dosing system at its facility in Alnwick, UK in what it called its “Fill-Inova” project, the company said. The R1000 machine includes two of 3P’s Fill2Weight filling modules,… Read more . . .
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The Cystic Fibrosis Foundation (CFF) has awarded Synspira Therapeutics up to $14 million in additional funding for development of two Synspira candidates including SNSP113, an inhaled polycationic glycopolymer for the treatment of CF. The foundation… Read more . . .
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Respira Therapeutics has announced that the results of Phase 1 and Phase 2a clinical studies of RT234-PAH dry powder vardenafil “support its further development as an as-needed (PRN) treatment that will allow patient-controlled dosing to… Read more . . .
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