BioCentury | Sep 21, 2015
Clinical News

Gepirone ER regulatory update

...FDA’s Psychopharmacologic Drugs Advisory Committee will meet on Dec. 1 to discuss an NDA for gepirone ER...
...agonist (see BioCentury, Nov. 12, 2007). Fabre-Kramer Pharmaceuticals Inc. , Houston, Texas Product: Gepirone ER (formerly Ariza...
BioCentury | Nov 12, 2007
Clinical News

Gepirone ER regulatory update

...Further details were not disclosed. Fabre Kramer granted GSK exclusive rights to develop and commercialize gepirone ER...
...February. Fabre Kramer Pharmaceuticals Inc. , Houston, Texas GlaxoSmithKline plc (LSE:GSK; GSK), London, U.K. Product: Gepirone ER...
BioCentury | Nov 6, 2007
Company News

FDA issues gepirone ER not approvable letter

...decision to determine next steps. Fabre Kramer granted GSK exclusive rights to develop and commercialize gepirone ER...
BioCentury | Oct 1, 2007
Finance

4Q milestones

...DORB) orBec beclomethasone dipropionate Graft-versus-host disease (GvHD) PDUFA date Oct. 21 Fabre Kramer/GlaxoSmithKline (LSE:GSK; GSK) Gepirone ER...
BioCentury | May 14, 2007
Clinical News

Gepirone ER regulatory update

...Fabre Kramer submitted an amended NDA to FDA for gepirone ER to treat major depressive disorder. The...
...In 2005, the company reported mixed results from a pair of Phase III trials of gepirone ER...
...gepirone ER. Fabre Kramer Pharmaceuticals Inc. , Houston, Texas GlaxoSmithKline plc (LSE:GSK; GSK), London, U.K. Product: Gepirone ER...
BioCentury | Feb 19, 2007
Company News

Fabre-Kramer Pharmaceuticals Inc., GlaxoSmithKline deal

...Fabre-Kramer granted GSK an exclusive, worldwide license to develop, manufacture and commercialize gepirone ER and follow-on products...
BioCentury | Jul 4, 2005
Clinical News

Gepirone ER: Phase III data

...In the double-blind, placebo-controlled, U.S. Phase III FKGBE008 in 206 patients, gepirone ER improved depressive symptoms, but...
...compared with placebo (44.8% vs. 30.6%, p=0.035). Fabre Kramer Pharmaceuticals Inc. , Houston, Texas Product: Gepirone ER...
BioCentury | Jul 4, 2005
Clinical News

Gepirone ER: Phase III

...Data from the double-blind, placebo-controlled, U.S. Phase III FKGBE007 in 248 patients showed that gepirone ER significantly...
...placebo (48.3% vs. 30.3%, p=0.007). Fabre Kramer Pharmaceuticals Inc. , Houston, Texas Business: Neurology Product: Gepirone ER...
BioCentury | Jun 30, 2005
Clinical News

Fabre-Kramer gepirone Phase III data

...Fabre-Kramer (Houston, Texas) said its gepirone ER met the primary endpoint in one U.S., double-blind Phase III...
...the endpoint in another to treat major depression. In the FKGBE007 trial in 248 patients, gepirone ER...
BioCentury | Jun 20, 2005
Company News

Akzo Nobel NV, Fabre-Kramer Pharmaceuticals Inc. deal

...Fabre-Kramer reacquired marketing rights to depression compound gepirone ER from AKZ's Organon subsidiary (Oss, the Netherlands). In...
...rights to the compound from Bristol-Myers Squibb Co. (BMY, Princeton, N.J.) in 1993 and licensed gepirone ER...
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