Archive for the 'Cystic Fibrosis' Category


Inspire Announces New Data From Denufosol Phase 3 Program At North American Cystic Fibrosis Conference

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the presentation of additional data from TIGER-1, the Company's first Phase 3 trial with denufosol tetrasodium for the treatment of cystic fibrosis, at the 22nd Annual North American Cystic Fibrosis Conference (NACFC) in Orlando, FL on October 23 - 25, 2008.
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Kamada Reports Positive Phase II Data With Inhaled AAT In Cystic Fibrosis

Kamada (TASE:KMDA), a biopharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today positive data from its Phase II study evaluating inhaled Alpha-1 Antitrypsin (AAT) delivered via an Investigational eFlow® Nebulizer System (PARI Pharma GmbH), in the treatment of cystic fibrosis.
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Promising New Approach To Treating Cystic Fibrosis Lung Infection

Researchers at the University of Calgary have found a new method of fighting severe lung infections in people with cystic fibrosis (CF). These findings are published in Proceedings of the National Academy of Science USA, this week. Communities of bacteria grow in the lungs of people with CF. Pseudomonas aeruginosa is a common bacterium found in these communities and is often associated with severe lung infections.
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Gilead Receives Complete Response Letter From U.S. FDA For Aztreonam Lysine For Inhalation, Investigational Cystic Fibrosis Treatment

Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for aztreonam lysine for inhalation, an investigational therapy in development for people with cystic fibrosis who have Pseudomonas aeruginosa (P. aeruginosa). In this letter, the FDA informed Gilead that the review of the company's NDA has been completed.
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Kamada Successfully Completes Phase II Trial With Aerosolized AAT In Cystic Fibrosis Patients

Kamada (TASE: KMDA), a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced that it has completed a Phase II Study with Aerosolized Alpha-1 Antitrypsin (AAT), delivered via an optimized eFlow platform nebulizer (PARI Pharma GmbH), in cystic fibrosis (CF).
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Inspire Provides Update On Cystic Fibrosis Clinical Program - Optimization Of TIGER-2 Trial Design

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced modifications to the clinical protocol for TIGER-2, the Company's ongoing second Phase 3 trial with denufosol tetrasodium for the treatment of cystic fibrosis (CF). "The availability of the extensive data set from the positive TIGER-1 trial provides an excellent opportunity to optimize the TIGER-2 trial design," stated Christy L. Shaffer, Ph.D., President and CEO of Inspire.
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