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Dyax has announced that two fully human monoclonal antibodies that were derived
from Dyax's proprietary phage display libraries have entered into Phase I
clinical development at ImClone Systems, as recently reported by the Dyax
library licensee.
Amarin has announced positive data analysis from two exploratory Phase IIa clinical
studies using Miraxion (formerly referred to as LAX-101c) to treat depression.
IGI has announced that, assuming successful completion of the proposed merger
between Manhattan Pharmaceuticals and Tarpan Therapeutics, Manhattan Pharmaceuticals
intends to pursue a Phase II clinical trial for PTH (1-34) using IGI's Novasome
nanovesicular topical delivery technology.
Barrier Therapeutics has reported positive Phase IIa data for both oral Rambazole
in the treatment of psoriasis, and for oral Azoline in the treatment of superficial
fungal infections.
Avanir Pharmaceuticals has announced that the company and the FDA have reached
agreement on Avanir's protocol for a Phase III clinical trial of Neurodex in
the treatment of painful diabetic neuropathy, a type of chronic neuropathic
pain.
Join FDAnews Jan. 20 for the 90-minute audio alert, "Clinical Trials:
Planning for a Lean, Mean Development Machine." Learn how to speed drug
approvals and cut costs from Dr. William Sietsema, one of the world's
top authorities on how to streamline the clinical development process. On Jan.
31 and Feb. 23, learn about "cGMP Predicate Rules: What FDA Expects from
Your Computer Systems." In this two-part audio tutorial, Keith Benze
of SEC Associates will identify and clarify the FDA's predicate rules for computerized
systems used in manufacturing processes.
Perlegen Sciences will commence a pharmacogenomics collaboration with Johnson
& Johnson Pharmaceutical Research and Development (J&JPRD), a Johnson
& Johnson company.
Sirna Therapeutics and Targeted Genetics have established a collaboration to
develop a novel therapy for the treatment of Huntington's Disease (HD), an incurable
neurodegenerative disorder.
Curis has announced that a recent online issue of the Journal of Biological
Chemistry contains a report demonstrating that treatment with BMP-7, a signaling
protein that was discovered by scientists from Curis, results in repair of kidney
injury in a preclinical model of acute kidney disease.
Dendreon has released the preliminary data from its D9902A study of Provenge,
the company's investigational immunotherapy for the treatment of advanced
prostate cancer.