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As lawmakers and the FDA mull over proposals to address recent drug safety concerns,
pharmaceutical firms are hoping that any potential fix will not focus on the
premarket side of the equation, according to a top FDA official.
Recent FDA warnings about the use of antidepressants in
children appear to be having a significant effect on the number of pediatric
prescriptions for the drugs, according to an analysis by one of the nation's
largest pharmaceutical benefit managers.
AstraZeneca's cancer treatment Iressa will be a main topic of discussion at
next month's meeting of the FDA's Oncologic Drugs Advisory Committee, which
will examine a recent clinical trial that raised questions about the drug's
effectiveness.
The FDA has issued a public call for information on the use of color on pharmaceutical
labeling and packaging to determine if the practice is one that warrants further
action from the agency.
Invitrogen has signed a definitive agreement to
acquire privately held molecular separation and purification technology pioneer
Dynal Biotech from majority owner Nordic Capital and a co-investor for approximately
NOK 2.5 billion.
Two men have been charged in a multimillion dollar scheme to sell counterfeit
and illegally imported Lipitor. Three others have already been convicted in
the plot.
New York's JDS Pharmaceuticals and the North Carolina-based arm of Synthon Pharmaceuticals
have entered into a co-promotion agreement for Lithobid, a leading brand of
twice-daily lithium carbonate for the treatment of bipolar disorder.
Sinovac Biotech Ltd. has announced that as of Feb. 4 it has completed the acquisition
of an additional 20.56 percent of its Beijing-based operating subsidiary, Sinovac
Biotech Co. Ltd. (Sinovac (Beijing)) for approximately US$3,310,000.
EpiTan has in-licensed the Australian and New Zealand rights to OraDisc A from
Access Pharmaceuticals (Dallas, Texas) as part of its strategy to establish
a specialty pharmaceutical business focused on ethical dermatology.