Part of the Quad combination product, stand-alone elvitegravir could open up the integrase inhibitor market. In a study supporting the single-agent NDA, once-daily elvitegravir proved comparable to Merck’s twice-daily blockbuster Isentress, the only commercially available integrase inhibitor.
Gilead Sciences Inc.’s submission of its HIV therapy elvitegravir to FDA, announced late June 27, could mean the beginning of competition in the integrase inhibitor field – and offer the first once-daily option.
Elvitegravir initially was developed by Japan Tobacco Inc., which licensed worldwide rights to Gilead in 2005. The drug, at...
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.
