Her areas of expertise include the cutting-edge early market access schemes that are being trialed around the world for taking drugs and medical devices to market faster. She is also interested in initiatives for harmonizing regulations at the global level as well as issues affecting clinical trials, manufacturing and post-market safety monitoring. She explores the challenges and opportunities that these issues introduce for both industry and the regulators and is on a constant look out for what might be coming next.
A scientist by training, Neena started her journalistic career at Informa in 1997. She has been the deputy editor of Scrip Regulatory Affairs since 2007. Prior to that, she worked as the science editor for Clinica Medtech Intelligence. Before becoming a journalist she worked as a biomedical scientist at St Thomas' Hospital in London for 10 years.
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Latest From Neena Brizmohun
Companies still need to replace the UK as their reference member state for around 6,000 products in Europe’s decentralized and mutual recognition procedures. Of the switches that have been completed so far, many have gone to Germany.
New guidance from the European Medicines Agency explains how sponsors that have drugs in its priority medicines scheme should interact with its experts and committees.
The European Medicines Agency’s priority medicines scheme, PRIME, attracts a lot of applications, but most of them fail. The agency has explained why and has updated it guidance documents for applicants.
With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.
With less than 11 months left to prepare for Brexit, companies with drugs in Europe’s decentralized and mutual recognition procedures are being urged to tell regulators if they are struggling to make the necessary changes by the March 2019 deadline for the UK to leave the EU.
The European Medicines Agency rejected Santhera’s Raxone as a treatment for Duchenne muscular dystrophy but the prospect of definitive data supporting the new indication means idebenone will still be available to patients in the UK under the early access scheme for promising new medicines.