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FDA approved Dr. Reddy’s ANDA for Lansoprazole delayed-release capsules
Dr. Reddy’s Laboratories announced that it will be launching Lansoprazole delayed-release capsules (15 mg and 30 mg), a bioequivalent generic version of Prevacid®* Delayed-Release Capsules, in the US market. The Food & Drug Administration (FDA) approved Dr. Reddy’s ANDA...
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Cephalon Announces FDA Approval of a Risk Evaluation and Mitigation Strategy for GABITRIL
Cephalon, Inc.announced that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication GABITRIL(R) (tiagabine hydrochloride) has been approved by the U.S. Food and Drug Administration (FDA). The GABITRIL REMS consists of a Medication Guide to inform patients...
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First HIV diagnostic assay Results Available in Less Than 50 Minutes
Ortho Clinical Diagnostics announced U.S. FDA approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems. This is...
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Bristol-Myers Squibb Completes Acquisition of ZymoGenetics, Inc.
Bristol-Myers Squibb Company announced that it has completed its previously announced acquisition of ZymoGenetics, Inc.. As a result of the transaction, ZymoGenetics has become a wholly-owned subsidiary of Bristol-Myers Squibb. Bristol-Myers Squibb initiated on September 10,...
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BioSpecifics Technologies Corp. Announces Initiation of Global Phase 3 Trial of XIAFLEX for Treatment of Peyronie’s Disease
BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, announced that its partner Auxilium Pharmaceuticals, Inc. (Auxilium) has dosed the first subject in the global Phase 3 program of XIAFLEX® (collagenase clostridium histolyticum) for the treatment...
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AstraZeneca and PoZEN received approval for VIMOVO in Europe
AstraZeneca and POZEN Inc. today announced that VIMOVO (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets has cleared an important regulatory milestone by receiving positive agreement for approval in 23 countries across the European Union (EU). This follows all 22...
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Bexion Pharmaceuticals Continues to Gain Support from National Cancer Institute (NCI)
Bexion Pharmaceuticals announced that it has been awarded a $1.5M Phase II Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI). The grant entitled “SapC-DOPS Nanovesicles for Treating Glioblastoma Multiforme” was awarded September 28, 2010 and...
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