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GPC Biotech AG has announced that the Committee for Orphan Medicinal Products
of the European Medicines Agency (EMEA) has recommended the granting of orphan
medicinal product designation for the anticancer monoclonal antibody 1D09C3
for the treatment of Hodgkin's lymphoma.
New River Pharmaceuticals has provided an update on its pipeline, including
results from preclinical testing on the company's second compound under development,
NRP290, a hydrocodone derivative for the treatment of pain.
Chiron and the Multiple Myeloma Research Consortium (MMRC) announced the initiation
of a Phase I clinical trial of CHIR-258 in multiple myeloma, a type of cancer.
The Immune Response has initiated a new arm of a Phase I/II clinical trial investigating
IR103, the company's newest product candidate for the treatment of HIV.
Immunomedics has begun patient dosing for the pivotal Phase III clinical trials
to further evaluate the safety and efficacy of the company's lead drug candidate,
epratuzumab, for the treatment of patients with systemic lupus erythematosus
(SLE), known as lupus.
Neurobiological Technologies (NTI) has selected SCIREX as its contract research
organization to manage its Phase III clinical program for Viprinex (Ancrod).
Join FDAnews June 16 for a 90-minute audioconference on "Adverse
Event Compliance in Clinical Trials: Know What to Report, When and How."
Hear Mark Barnes, one of the world's most sought-after advisers on compliant
clinical research programs, demystify adverse reporting for your clinical trials.
On June 22, join FDAnews for "Root Cause Analysis: Understand Failures,
Exceptions and Nonconformances." A veteran of hundreds of failure investigations
will explain the fundamentals of developing, implementing and documenting an
effective root cause analysis under your CAPA requirements.