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
The European Medicines Agency is this week deciding whether GlaxoSmithKline’s planned EU marketing application for its BCMA-targeting therapy merits an accelerated assessment.
Three global guidances dating back 10 years or more have been updated by the International Medical Device Regulators Forum (IMDRF).
Heath technology assessment body NICE says it has relaunched its international division to deal with the growing number of enquiries for advice it has been receiving from government agencies and organizations abroad.
Provention Bio’s teplizumab, a potentially game-changing treatment for preventing or delaying type 1 diabetes, is one of three investigational products to be newly accepted onto the European Medicines Agency’s popular priority medicines scheme.
The European Medicines Agency's drug safety committee has concluded that Pfizer's Xeljanz could increase the risk of blood clots in patients who are already at high risk. The committee has also recommended restrictions on the use of Sanofi's multiple sclerosis drug, Lemtrada.
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Astellas Pharma's Xospata (gilteritinib) for treating relapsed or refractory acute myeloid leukemia. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).