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Dendreon has announced that Provenge, the company's investigational immunotherapy
for the treatment of prostate cancer, significantly improved survival in men
with asymptomatic, metastatic androgen-independent (hormone-refractory) prostate
cancer when compared to patients receiving placebo.
Join FDAnews Feb. 24 to learn about "Drug Marketing Practices in
Europe: Navigating Tough Rules and New Enforcement," a 90-minute audioconference.
Hear former FDA official Linda Horton, now an attorney with Hogan &
Hartson, explain how the new EU Community Code on Medicinal Products affects
your marketing activities, including your relationship with health professionals.
On Feb. 25, receive a concise and expert analysis of the "Medicare Part
D for Drugmakers: New Requirements, New Risks, New Markets," presented
in a 90-minute audioconference by Keith Korenchuk of McGuireWoods and
Sheryl Vacca of Deloitte & Touche.
Solvay Pharmaceuticals and CV Therapeutics has announced that the FDA has
accepted Solvay Pharmaceuticals' supplemental new drug application (sNDA)
for Aceon tablets for filing.
The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting
applications from U.S. and overseas research institutions seeking to become
Clinical Trials Units (CTUs) in the Institute's revamped HIV/AIDS Clinical
Trials Networks.
Xcyte Therapies has announced the publication of a scientific paper describing
the mechanism of action of its lead product, Xcellerated T Cells, in chronic
lymphocytic leukemia (CLL).
Patients with moderate-to-advanced Parkinson's disease (PD) experiencing motor
complications who added once-daily Agilect to their treatment with optimized
levodopa with or without stable doses of other anti-PD medications experienced
a significant improvement in their PD symptoms and a significant reduction
in "off" time, according to the PRESTO study published in the February
issue of Archives of Neurology.
Point Therapeutics has successfully completed the first stage of the company's
Phase II single-agent study of talabostat in patients with advanced metastatic
melanoma.
Critical Therapeutics has initiated a Phase II clinical trial of CTI-01, an
anti-inflammatory compound that it is developing for the treatment of certain
critical care conditions.