EU Accelerated Assessment Tracker: Second Half Trumps First By Far
Executive Summary
The first half of the year was pretty bleak for companies seeking fast-track review of their products in the EU. There has been much better news in the second half. The Pink Sheet tracks the winners and losers.
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Novartis And Stemline Try For Fast-Track EU Review
The European Medicines Agency is this week deciding whether it will fast track its review of orphan drugs that Novartis is developing for the treatment of Cushing's syndrome and Stemline Therapeutics is developing for the hematologic malignancy, BPDCN.
Daiichi Sankyo Seals Speedier Europe Review For Quizartinib
The acute myeloid leukemia drug is the lead candidate in the strong oncology pipeline the Japan-headquartered company has assembled over the past couple of years.
Merck Looks To Add Pneumonia To Zerbaxa Label; Market Value Not Clear
Merck unveiled Phase III data showing efficacy in hospital-acquired bacterial pneumonia, but branded drugs with this indication currently have not scored significant sales.