Neena has been covering regulatory, business and market access developments that impact pharmaceutical and medical device companies since 1997. She explores the challenges and opportunities that developments worldwide introduce for industry and regulators. Her areas of expertise include regulatory schemes for getting products to market faster. Neena's other specialist areas include new medicines coming to market in the EU, pricing and reimbursement, clinical trials, real-world evidence, post-marketing safety monitoring, transparency policies relating to the publication of trial data, and global harmonization initiatives for pharma and medtech.
Latest from Neena Brizmohun
Canada’s Drug Agency is also looking to consider the impact on productivity outcomes for both patients and informal caregivers when assessing the value of a drug.
According to the health technology assessment institute, NICE, new cost-effectiveness thresholds – which are higher than those that applied when the original decisions were made – will apply when its committee reconsiders the appraisals for Eisai and Eli Lilly’s Alzheimer’s disease drugs.
A regulatory roadmap and product development tracker, expedited scientific advice, and submission readiness meetings are being integrated into the European Medicines Agency’s decade-old priority medicines scheme.
Asieris Pharmaceuticals' hexaminolevulinate, for treating high-grade squamous intraepithelial lesions, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Novartis’s ianalumab, for treating Sjögren’s disease, is also among the new drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.
So far this year, four drug candidates have secured a place on the European Medicines Agency’s priority medicines scheme for promising treatments for unmet medical needs.