EMEA Recommends No New Action On Non-Selective NSAID Thrombotic Risk
This article was originally published in The Pink Sheet Daily
European Medicines Agency is still reviewing gastrointestinal and serious skin infection safety.
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European Medicines Agency concludes its review of the COX-2 class with formal recommendation to remove Bextra from the market and additional contraindications and warnings for class labeling. The agency will now turn its attention to the safety profile of “some conventional” NSAIDs.
Italy claims to have pushed farther into managed entry agreements than other European countries with strong clawback provisions on new drugs – particularly cancer drugs – if they don't work as well as their manufacturers claim. The financial clawbacks are supported by extensive outcome data collection across the country's twenty regions.
The U.K.’s Health and Social Care Bill was introduced into Parliament on Jan. 19, offering a new commercial landscape best navigated by pharma through bolstered relationships with general practitioners.