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
EMA Report Highlights Parallel Regulatory/HTA Consultations Among Achievements
A report from the EMA summarizing the mid-term achievements of its Regulatory Science Strategy to 2025 covers health technology assessments and a range of other topics.
Upstaza: First Gene Therapy For Ultra-Rare Disorder AADC Deficiency Receives English Funding
The single-dose gene therapy for aromatic L-amino acid decarboxylase in children is to be made available on the National Health Service following a confidential commercial deal between NHS England and PTC Therapeutics.
‘Gene Silencing’ Drug Oxlumo Wins English Funding After Alnylam Improves Discount
Health technology assessment institute NICE has reversed its provisional rejection of Oxlumo for treating the rare disease, primary hyperoxaluria type 1.
New EU Filings
Sugemalimab, from CStone Pharmaceuticals/EQRx, for use in combination with chemotherapy as first-line treatment for metastatic non-small cell lung cancer, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Fastest Ever Review For A Product In EMA's PRIME Scheme
The European Medicines Agency says that when it comes to products developed under its priority medicines scheme, dialog is crucial to ensure that the data generated for marketing applications are sufficiently robust and mature and facilitate a timely review.
Novel Anti-Hypertensive Treatment & NSCLC Drug Among New EU Filings
The European Medicines Agency has added five new drugs to its latest monthly list of medicines that are under review for potential EU marketing approval.