Optimer's Fidaxomicin Among Three NMEs Given Positive Review By Europe's Regulators
• By The Pink Sheet Daily
EU's scientific advisory panel also recommends approval for Takeda's azilsartan and Tibotec's rilpivirine, and grants positive opinions on new indications for Bayer/Johnson & Johnson's rivaroxaban and Alexion's eculizumab.
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The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.