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Discovery Laboratories has suffered a setback in its development of respiratory
drug Surfaxin when the contract manufacturer hired to produce the product was
issued a Form 483 by the FDA.
The FDA is eager for industry to implement the Clinical
Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) so
reviewers can gain experience with the standard, but industry has been slow
to respond, FDA officials said at a recent public meeting at agency headquarters
in Rockville, Md.
The NIH has announced a new supplemental ethics regulation that essentially
bans its employees from collaborating with pharmaceutical and biotechnology
companies.
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.
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.
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.
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.