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Join FDAnews Thursday, May 19, for a 90-minute audioconference on "Preparing
Successful eCTDs: Compliant Submissions the First Time, Every Time." Learn
how to correctly prepare your electronic common technical documents to the FDA's
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California's New Mandatory Rules for Drug and Device Firms: Compliance and Marketing
Strategies to Meet Your July 1 Deadline." Learn about the landmark legislation
that is changing the rules for drugmakers and devicemakers in California, the
key components for meeting the deadline, and how others are complying.
The European Patent Office has granted Alnylam Pharmaceuticals a new patent
with broad claims covering short interfering RNAs (siRNAs), the molecules that
mediate RNA interference (RNAi).
Nabi Biopharmaceuticals has initiated its PhosLo (calcium acetate) EPICK study
in chronic kidney disease (CKD) patients suffering from Stage 4 kidney disease.
Guilford Pharmaceuticals has published results from the STRATEGY trial of Aggrastat
injection (tirofiban HCl) in The Journal of the American Medical Association.
Further evidence that statin drugs may help in the fight against Alzheimer's
disease has been provided by a prospective double-blind study of Alzheimer's
disease patients published in the current issue of the Archives of Neurology.
Medarex has announced the allowance of an investigational new drug application
filed with the FDA to initiate a Phase I clinical trial for MDX-1100, a fully
human monoclonal antibody that targets IP-10 (also known as CXCL10), for the
treatment of ulcerative colitis.
DeCODE genetics announced the publication of a landmark article by a team of
its scientists presenting the results of Phase II clinical studies of DG031,
the company's lead compound being developed for the prevention of myocardial
infarction, or heart attack.