- Genelabs Technologies has received orphan drug designation for prasterone (Prestara), its investigational drug for lupus.
- Novartis has announced that its New Drug Application for deferasirox (Exjade) has been granted priority review by the FDA as a once-daily oral iron chelator for the treatment of chronic iron overload due to blood transfusions.
- Dendreon Corp. has completed enrollment in its Phase III PROTECT (P-11) clinical trial of APC8015 (Provenge) in men with nonmetastatic androgen-dependent (hormone-sensitive) prostate cancer.
- Dynavax Technologies Corp. has initiated a pivotal Phase III clinical trial of its hepatitis B vaccine.
- LAB International has initiated enrollment in a Phase I trial for its novel asthma product LAB CGRP (Calcitonin Gene-Related Peptide).
- Arginox Pharmaceuticals has begun patient enrollment in TRIUMPH, a pivotal Phase III trial of the drug, Tilarginine Acetate Injection (TAI), for the treatment of cardiogenic shock.
- Cell Genesys has initiated a second multicenter Phase III clinical trial of Gvax vaccine for prostate cancer in patients with metastatic hormone-refractory prostate cancer.
- Speedel announces the start of its Phase III study for SPP301, its once-a-day oral endothelin A receptor antagonist in the indication of diabetic nephropathy.
- ID Biomedical Corp. has been advised by the FDA’s Center for Biologics Evaluation and Research (CBER) that the company’s influenza virus vaccine (Fluviral) has been granted a fast-track designation.
- Keryx Biopharmaceuticalshas initiated its pivotal Phase III and Phase IV clinical program with oral sulodexide gelcap (KRX-101) for the treatment of diabetic nephropathy.
- CV Therapeutics has initiated a clinical program for CVT-6883, a selective, potent, and orally available A2B-adenosine receptor antagonist, intended to treat asthma with once-a-day dosing.
- Sangart has initiated a Phase II clinical trial involving MP4 (Hemospan), a hemoglobin-based oxygen carrier designed to serve as an alternative for blood transfusions.
- Cylene Pharmaceuticals has initiated a Phase I clinical trial for CX-3543, its lead candidate for the treatment of multiple cancers.
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