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.
Latest From Neena Brizmohun
Roche has resolved the issues raised by the health technology assessment body over what is the first immunotherapy approved for treating this aggressive and difficult-to-treat form of breast cancer.
The country's Therapeutic Goods Administration has explained how sponsors can apply for expedited approval of tests for COVID-19 and what special conditions apply. Meanwhile, post-market reviews of two approved serology-based COVID-19 point-of-care tests suggest they are not as sensitive as their manufacturers had claimed.
Speaking at a high-level European Parliament committee meeting today about COVID-19, the European Medicines Agency’s executive director indicated that Gilead would be submitting a conditional marketing authorization application for remdesivir in the EU.
Pfizer has dropped the price it was asking for Lorviqua, and evidence from the Cancer Drugs Fund appears to support the clinical trial evidence for Roche’s Gazyvaro.
New medicines under evaluation at the European Medicines Agency.
There is an unmet clinical need for an additional adjuvant therapy for people who have residual disease after neoadjuvant therapy, says health technology assessment body NICE.