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Novavax has announced positive results from preclinical studies applying its
proprietary micellar nanoparticle (MNP) technology to transdermally deliver
five drugs.
In multiple preclinical studies, second-generation antisense drugs selectively
inhibited activity of proteins that promote inflammation and improved a variety
of symptoms in mouse models of asthma and chronic lung inflammation, according
to data from Isis Pharmaceuticals.
Oleoyl-estrone (OE), the lead product candidate of Manhattan Pharmaceuticals,
demonstrated efficacy in inducing significant weight loss in a preclinical pharmacology
study when administered alone and in combination with other obesity treatments.
YM BioSciences has announced that Norelin, its anticancer vaccine targeting
the gonadotropin releasing hormone (GnRH), has successfully completed a proof-of-concept
study in men with hormone dependent prostate cancer (HDPC).
Ariad Pharmaceuticals has begun enrollment of patients with relapsed and/or
refractory cancers in the first multicenter Phase Ib clinical trial of the oral
dosage form of its novel mTOR inhibitor, AP23573, which was recently designated
as a fast-track product by the FDA for the treatment of sarcomas.
Nuvelo has finalized the design of the Phase III program for its lead product
candidate, alfimeprase, for the treatment of central venous catheter occlusion.
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.
Brazil's National Health Surveillance Agency (Agencia Nacional de Vigilancia
Sanitaria) has granted approval for Eyetech Pharmaceuticals' Macugen (pegaptanib
sodium injection) for the treatment of neovascular age-related macular degeneration
(AMD).