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Memory Pharmaceuticals has announced that Roche has decided not to pursue further
development of MEM 1414 and MEM 1917 on its own, and that the two companies
have commenced discussions to determine the future of these two compounds.
Peregrine Pharmaceuticals has announced that a paper published in the April
15 issue of Clinical Cancer Research shows the antibody-targeted VEA
(vasopermeability enhancing agent) NHS76/PEP2 greatly enhanced the uptake and
efficacy of a variety of chemotherapeutic agents in solid tumor models.
One-year data from the Phase III SENTINEL trial demonstrated that when Tysabri
was added to Avonex in patients with relapsing forms of multiple sclerosis (MS),
the annualized clinical relapse rate was reduced by 54 percent over the effect
of Avonex alone.
Idenix Pharmaceuticals has announced preliminary Phase IIa clinical trial data
for valopicitabine (NM283) in treatment naive genotype 1 hepatitis C patients.
Adventrx Pharmaceuticals has received clearance from the Medicines and Healthcare
products Regulatory Agency to begin an international Phase IIb randomized controlled
clinical trial using CoFactor with 5-fluorouracil (5-FU) in metastatic colorectal
cancer in the UK.
Avanir Pharmaceuticals has released data from its Phase III clinical trial examining
Neurodex in the treatment of pseudobulbar affect (PBA) in patients with multiple
sclerosis (MS).
Join FDAnews Tuesday, April 19, for a 90-minute audioconference, "Innovate
or Stagnate: How to Generate Breakthrough Ideas for Quality Control and Continuous
Improvement." Learn from David Markovitz and Lynda Curtin,
two industry experts who collectively have more than 50 years of experience
in quality systems, innovation and continuous improvement. On April 29, join
FDAnews for the "New GAMP Guide for Electronic Records: A Prelude
to the FDA's Next Part 11 Requirements?" This 90-minute audioconference
gives you a head start on complying with the "next" version of Part
11 with practical training from pre-eminent GAMP expert Per Olsson.
OSI Pharmaceuticals has announced that its patent application covering claims
for its lead c-Kit/KDR compound, OSI-930, has received notice of allowance by
the U.S. Patent and Trademark Office.
ImClone Systems and Bristol-Myers Squibb intend to file a supplemental biologics
license application (sBLA) to seek approval of Erbitux (Cetuximab) for use as
a single agent and in combination with radiation in squamous cell carcinoma
of the head and neck with the FDA before the end of the year.