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The European Medicines Agency has outlined the steps companies should follow once they secure orphan status for a medical product to maintain that status and secure marketing authorization. Read More
An ex-Turing executive took his former employer to task on Thursday, telling lawmakers the drugmaker’s decision to raise the price of Daraprim by 5,000 percent was “unjustified.” Read More
FDA Reminds Drugmakers to Upgrade to New Data Format
GSK, Miltenyi Biotec to Develop Cell and Gene Therapy
Novimmune Scores Breakthrough Designation for NI-0501
Raptor Lands Qualified Infectious Disease Product Designation for Inhaled Levofloxacin
Sanofi, DiCE Molecules Ink Deal Potentially Worth More Than $2B Read More
A jury sided with Amgen Wednesday in a suit accusing Regeneron and Sanofi of violating two of its patents when they developed a cholesterol-fighting biologic. Read More