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The FDA has made significant revisions to a November 1999
guidance that provides recommendations on the types of drug impurity data included
with drug applications.
A federal court has issued preliminary approval for a $36 million settlement
agreement that would resolve allegations that New Jersey-based drugmaker Organon
USA engaged in anticompetitive acts related to its depression drug Remeron.
ViroLogic has signed a three-year, $7.5 million service agreement with GlaxoSmithKline
(GSK) to use ViroLogic's novel HIV resistance testing technology to support
GSK's drug discovery and development programs.
Vasogen, focused on the research and commercial development of technologies
targeting chronic inflammation underlying cardiovascular and neurological disease,
has completed its previously announced registered direct offering of approximately
9 million of its common shares at a price of US$4.70 per share to institutional
investors, for gross proceeds of approximately $42.3 million.
The Alliance for Lupus Research has awarded a $1 million grant to Argos Therapeutics
for development of a therapeutic antibody product for systemic lupus erythematosis
based on research conducted at Baylor Institute for Immunology Research.
Accelovance has completed the asset purchase of nTouch Research, a Raleigh,
N.C.-based site management organization (SMO). Financial details were not disclosed.
The California Supreme Court has agreed to review a $500 million jury verdict
against biotechnology company Genentech for failing to pay royalties on some
drugs manufactured under a 1976 agreement with the City of Hope Medical Center.
Eisai has agreed with Chugai Pharmaceutical to transfer the sales operations
of Inhibace, an antihypertensive agent first synthesized by Roche. Under the
terms of the agreement, Chugai will become a sole distributor of Inhibace as
of April 1.
MedImmune, which struck a deal with GlaxoSmithKline (GSK) eight years ago to
develop a cervical cancer vaccine, may get more mileage out of the deal through
a partnership GSK has with fellow drugmaker Merck.