News
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 12 to 2 in favor of approval for Forest Laboratories’ and Almirall’s NDA for a 400 μg twice daily dose aclidinium bromide inhalation powder to treat… Read more . . .
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Among the warning letters posted to the FDA website on February 21, 2012 is a letter to FSC Laboratories dated June 9, 2011 detailing violations related to quality controls for the manufacture of the E-Z… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) will meet on Thursday, February 23 to decide whether or not to approve Forest Labs’ aclidinium bromide inhalation powder for the treatment of COPD. Forest submitted an NDA… Read more . . .
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Aradigm has announced that the United States Patent and Trademark Office has issued an additional patent covering several formulations of ciprofloxacin, including the company’s lead product, Pulmaquin dual release ciprofloxacin for inhalation. The patent (US… Read more . . .
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Inhalation testing specialist Frank Chambers has launched a new analytical consultancy specializing in OINDP testing called Inhalytic. Chambers, whose most recent position was as Senior Scientist at AstraZeneca, where he performed analytical research on inhaler… Read more . . .
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According to the Associated Press, the FDA will investigate the safety of Aeroshot inhalable caffeine and whether the product can be considered a dietary supplement as the manufacturer claims or if it is subject to… Read more . . .
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Irish nebulizer manufacturer Aerogen has received authorization from the Chinese State Food and Drug Administration (SFDA) to market its Aeroneb Pro and Aeroneb Go vibrating mesh nebulizers in China. The company expects to begin selling… Read more . . .
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Alexza Pharmaceuticals, which is developing a number of inhaled drugs using its proprietary Staccato inhaler, will offer 44,000,000 shares of common stock and 44,000,000 warrants to purchase common stock at $0.50 per share for a… Read more . . .
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Critical Pharmaceuticals and the University of Nottingham have announced a new partnership for development of a “nano-enabled” intranasal formulation of teriparatide for the treatment of osteoporosis. Funding for the £545,000 collaboration is coming from the… Read more . . .
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US pharmaceutical company Acorda Therapeutics President and CEO Ron Cohen has announced that the company is “excited” about an agreement with Neuronex, Inc. that will allow Acorda to acquire the company and its diazepam nasal… Read more . . .
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