Brexit And Cooperation: Insights From Danish Medicines Agency Head Thomas Senderovitz
It was inevitable that Brexit would be the key theme of an interview with Danish Medicines Agency head Thomas Senderovitz earlier this year. The senior European regulator oversees one of the agencies that has taken on new staff to help deal with the impact, in drug regulatory terms, of the vote by the UK in June 2016 to leave the European Union. Senderovitz also chairs the management group of the EU Heads of Medicines Agencies network.
You may also be interested in...
Santhera needs more time to address concerns regarding its current EU application for idebenone in the DMD setting but the Swiss biotech is keeping its sights on a broader indication.
EU approval is a formality for the eight products given the nod this week at the European Medicines Agency. There's no word, though, on filgotimid, from Gilead/Galapagos.
The May meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, is under way. Decisions are due on whether eight marketing approval applications should be approved for marketing in the EU.