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Join FDAnews Tuesday, Sept. 12, for "Complying with New Cardiac Safety Guidelines for Clinical Trials: Best Practices for Conducting QT Tests." In this 90-minute interactive audioconference, Daniel B. Goodman, M.D., director of medical affairs, Covance Cardiac Safety Services, hands you best practices for development and implementation of a reliable, cost-effective QT prolongation trial that meets the FDA's expectations. On Sept. 21, join FDAnews for "Reduce cGMP Inspections: Lower Your Site Risk Potential (SRP) Score." In this 90-minute audioconference with Q&A session, Justin O. Neway, Ph.D., vice president and chief science officer, Aegis Analytical Corp., hands you proven strategies to reduce SRP scores.
Taro Pharmaceutical Industries has received approval from the FDA for its abbreviated new drug application for extended-release phenytoin capsules 100 mg.
Orexo's European licensing partner ProStrakan has applied to obtain marketing approval in Europe for Rapinyl, Orexo's patented product for the treatment of breakthrough cancer pain.
Maxygen has initiated a Phase I trial in the United States to evaluate the safety, tolerability and pharmacokinetic and pharmacodynamic profile of Maxy-G34, a next-generation granulocyte colony-stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia.
Teva Pharmaceutical announced that a Phase IIb study designed to evaluate the safety and efficacy of laquinimod in relapsing-remitting multiple sclerosis (MS) patients met its primary end-point.
Results of Phase II studies of Bayer's rivaroxaban, an oral Factor Xa inhibitor for the treatment of deep vein thrombosis (DVT), were presented at the World Congress of Cardiology in Barcelona.
GTx announced that a per-protocol interim safety review by an independent drug safety monitoring board (DSMB) recommended the company continue clinical development as planned with its two Phase III trials of Acapodene (toremifene citrate).