BioCentury | Jan 13, 2014
Clinical News

Colobreathe colistimethate sodium regulatory update

...it submitted a regulatory application to Brazil's Agencia Nacional de Vigilancia Sanitaria (ANVISA) for Colobreathe colistimethate sodium...
...to treat chronic lung infection caused by Pseudomonas aeruginosa in CF patients ages >=6 years. Colobreathe...
...Forest (see BioCentury, Oct. 29, 2012). Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Product: Colobreathe colistimethate sodium...
BioCentury | Jun 3, 2013
Finance

Seeds to trees

...years and is a market leader in producing non-beta lactam APIs such as vancomycin and colistimethate sodium...
BioCentury | 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...
...Colobreathe was "less effective and less costly than nebulized tobramycin" (see BioCentury, Oct. 29, 2012). Colobreathe...
...Orphan Drug status in the EU. Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Product: Colobreathe colistimethate sodium...
BioCentury | 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...
...nebulized colistimethate, a generic antibiotic, is not tolerated. The decision is contingent on Forest providing Colobreathe...
...Orphan Drug status in the EU. Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Product: Colobreathe colistimethate sodium...
BioCentury | 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...
...the companies providing their respective therapies at an undisclosed discount under a patient access scheme. Colobreathe...
...tolerated. The recommendation reverses draft guidance issued last October. At the time, NICE said that Colobreathe...
BioCentury | 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...
...committee's preferred economic analysis showed Colobreathe was "less effective and less costly than nebulized tobramycin." Colobreathe...
...Orphan Drug status in the EU. Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Product: Colobreathe colistimethate sodium...
BioCentury | 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...
...in the EU for the indication. Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Product: Colobreathe colistimethate sodium...
BioCentury | Jan 3, 2011
Company News

Forest Laboratories, Gruenenthal deal

...B.V. subsidiary acquired from Gruenenthal its rights to antibiotic colistin and reacquired rights to Colobreathe colistimethate sodium...
...period of time, with a PDUFA date of Jan. 7, 2011. Forest licensed rights to Colobreathe...
...EMA) to treat Pseudomonas aeruginosa pulmonary infection in CF patients ages six years and up. Colobreathe...
BioCentury | 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...
...in the EU for the indication. Forest granted Gruenenthal Group (Aachen, Germany) rights to commercialize Colobreathe...
...and Ireland, where Forest retains rights. Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Product: Colobreathe colistimethate sodium...
BioCentury | Jan 2, 2006
Clinical News

Colobreathe colomycin: Phase III started

...has Orphan Drug designation in Europe. Forest Laboratories Inc. (FRX), New York, N.Y. Product: Colobreathe colomycin...
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