Hits, Misses & Key Firsts For EMA’s PRIME Scheme
The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.
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European Expedited Programs & Harnessing HTA
European regulators are exploring their interactions with health technology appraisal bodies to improve expedited programs that aim to get medicines to patients more quickly.
Expedited Programs: Overworked Staff & Financial Motives
A shortage of staff and expertise at regulatory agencies as well as tough eligibility criteria can impact expedited programs and their capacity to help deliver quicker access to innovative products.
BioMarin’s Roctavian & Argenx’s Efgartigimod Among Eight Hopefuls Awaiting EU Verdict
Will BioMarin be second time lucky with its hemophilia gene therapy Roctavian in the EU? The European Medicines Agency could soon decide whether the product should be approved.