Subject to securing an agreement with the FDA, Duska intends to initiate a single, prospective, double-blind, placebo-controlled and randomized Phase III clinical trial with its lead product ATPace.
Dr Thieroff-Ekerdt will have full responsibility for managing Eurand’s clinical R&D, medical and regulatory affairs, and drug safety and surveillance activities. Before joining Eurand, Dr Thieroff-Ekerdt was vice
If approved, trabectedin combined with Doxil will provide a new, non-platinum treatment option for these patients in the US, said Ortho Biotech. The application follows the completion of
SuperGen will initiate a Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic profile of SGI-1776, an orally administered, small molecule anticancer compound. The first in
The opening of this investigational new drug (IND) application, submitted in early October 2008, allows Resolvyx to initiate its first clinical trial, which will be a placebo-controlled, Phase
Cook Medical said that the trial, which will include 24 sites, is designed to evaluate the safety and effectiveness of the smaller endograft delivery system in 120 patients,
The Infectious Disease Research Institute (IDRI) retains worldwide exclusive rights to glycopyranosyl lipid adjuvant (GLA) for selected diseases affecting predominately the developing world. Under the agreement, IDRI will
Under the terms of the agreement, Mingyuan will serve as the exclusive distributor in China and Hong Kong of a series of newborn screening products being developed for
Currently enrolling patients at The Methodist Hospital in Houston, Texas, Baylor University Medical Center in Dallas, Texas and The University of Utah School of Medicine in Salt Lake
Janssen-Cilag recalled Ionsys in the European Union (EU) in September 2008, as a precautionary measure following identification of corrosion in a component of the system in one lot
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