BC Week In Review | Jan 13, 2014
Clinical News

Colobreathe colistimethate sodium regulatory update

Marketing partner moksha8 Pharmaceuticals Inc. (Wayne, Pa.) said it submitted a regulatory application to Brazil's Agencia Nacional de Vigilancia Sanitaria (ANVISA) for Colobreathe colistimethate sodium to treat lung infections in patients with cystic fibrosis. In...
BioCentury | Jun 3, 2013
Finance

Seeds to trees

Flush with cash from its existing holdings and not seeing enough worthwhile venture deals to spend it on, Novo A/S has decided to expand its growth equity investments in mature companies. After a proof-of-principle deal...
BC Week In Review | Apr 1, 2013
Clinical News

Colobreathe colistimethate sodium regulatory update

The U.K.'s NICE issued final guidance recommending Colobreathe colistimethate sodium from Forest to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients if nebulized colistimethate, a generic antibiotic, is not tolerated...
BC Week In Review | Jan 28, 2013
Clinical News

Colobreathe colistimethate sodium regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending Colobreathe colistimethate sodium from Forest to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients if nebulized colistimethate, a generic antibiotic,...
BC Extra | Jan 25, 2013
Company News

NICE now backs Colobreathe, Tobi Podhaler

The U.K.'s NICE issued final appraisal determinations recommending Colobreathe colistimethate sodium from Forest Laboratories Inc. (NYSE:FRX) and TOBI Podhaler from Novartis AG (NYSE:NVS; SIX:NOVN) to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic...
BC Week In Review | Oct 29, 2012
Clinical News

Colobreathe colistimethate sodium regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending against the use of Colobreathe colistimethate sodium from Forest Labs to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients - its approved indication....
BC Week In Review | Mar 5, 2012
Clinical News

Colobreathe colistimethate sodium regulatory update

The European Commission approved Colobreathe colistimethate sodium to treat chronic lung infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients ages >=6 years. The inhaled dry powder polymyxin antibiotic has Orphan Drug status in...
BC Week In Review | Jan 3, 2011
Company News

Forest Laboratories, Gruenenthal deal

Forest's Forest Healthcare B.V. subsidiary acquired from Gruenenthal its rights to antibiotic colistin and reacquired rights to Colobreathe colistimethate sodium to treat bacterial infections in patient with cystic fibrosis (CF). Gruenenthal, which currently markets colistin...
BC Week In Review | Sep 21, 2009
Clinical News

Colobreathe colistimethate sodium regulatory update

Forest submitted an MAA to EMEA for Colobreathe colistimethate sodium to treat Pseudomonas aeruginosa pulmonary infection in cystic fibrosis (CF) patients ages 6 years and up. The inhaled dry powder polymyxin antibiotic has Orphan Drug...
BC Week In Review | Jan 2, 2006
Clinical News

Colobreathe colomycin: Phase III started

FRX started the European Phase III trial (Freedom Study). The inhaled formulation has Orphan Drug designation in Europe. Forest Laboratories Inc. (FRX), New York, N.Y.   Product: Colobreathe colomycin   Business: Infectious   Molecular target:...
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