News bites
EMA–FDA joint inspections
The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections;
the latest move following 0completion of pilot projects this summer. The initiative will begin in January 2012.
Read more at:
http://www.PharmTech.com/jointgmp
Merck resolves charges
Merck & Co. has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing
of the painkiller Vioxx. The charges relate to off-label marketing. Under the agreement, Merck will plead guilty to a misdemeanor
for its illegal promotional activity and will pay a $321,636,000 criminal fine.
Read more at:
http://www.PharmTech.com/vioxx
FDA decides Avastin fate
The breast cancer indication for Avastin has been revoked in the US after the FDA Commissioner concluded that the drug has
not been shown to be safe and effective for this use. The drug will, however, remain on the US market as an approved treatment
for certain types of colon, lung, kidney and brain cancer.
Read more at:
http://www.PharmTech.com/fdaavastin
EC battles superbugs
The EC has unveiled an action plan against antimicrobial resistance, including provisions to promote R&D as well as the possibility
of establishing fast-track procedures for marketing authorisations. Among other areas, the EC has highlighted the development
of new antimicrobials for treatment as a priority.
Read more at:
http://www.PharmTech.com/superbugs
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