Bayer may have a better shot of gaining FDA approval of expanded professional labeling for aspirin by pursuing an indication for prevention of non-fatal myocardial infarction. The firm got a negative advisory committee vote for prevention of all MIs at a Dec. 8 meeting
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Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.
England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.
The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
