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PharmTech Europe


Pharmaceutical Technology Europe
Volume 24, Issue 1

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.

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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.

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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The breast cancer indication for Avastin has been revoked in the US after the FDA Commissioner concluded that the drug has not been shown to be safe and effective for this use.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.

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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.

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology Europe,
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