FDA’s decision to approve the 150 mg strength of Boehringer Ingelheim GmbH’s antithrombotic Pradaxa (dabigatran), but not the 110 mg dose, reflects agency doubts about the ability of risk management tools to change prescriber behavior that is likely to result in inappropriate use of a less effective dose.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.
The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
