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
In 2025, 43 drugs containing new active substances (NASs) were approved in the EU, and 2026 has already seen three NAS approvals with more expected soon. Also, for 1H 2026, the EU regulator has received 84 letters of intent for marketing applications for new drugs, of which 58 contain NASs.
Zidebactam/cefepime, Wockhardt's novel antibiotic treatment for resistant Gram-negative infections, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Preference research is a large and evolving field, says the International Council for Harmonisation.
The health technology assessment institute said its recommendation for the multiple sclerosis drugs, Tysabri and Tyruko, highlighted its continued efforts to drive the adoption of biosimilars across the National Health Service.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Wayrilz, Sanofi's treatment for immune thrombocytopenia.
The health technology assessment institute said its recommendation for the multiple sclerosis drugs, Tysabri and Tyruko, highlighted its continued efforts to drive the adoption of biosimilars across the National Health Service.