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
UK regulator says new datasets can be used instead of real-patient data in the development of algorithms for diagnostics and monitoring.
Limitations in the design of the clinical trials that were carried out for each drug are among the concerns highlighted by the health technology assessment body in two interim guidances that are now out for consultation.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include eight new products, including Roche's Rozlytrek (entrectinib) for the histology-independent indication of treatment of patients with NTRK fusion-positive solid tumors, and for treating patients with ROS1-positive advanced non-small cell lung cancer. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
International regulators have agreed on primary endpoints that would be suitable for assessing the clinical benefit of an investigational therapeutic for COVID-19 and support regulatory approval.
NICE says that Bavencio plus Inlyta will be made available via the Cancer Drugs Fund for advanced kidney cancer while more evidence is collected to support the combination therapy's routine use on the National Health Service.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.