Neena Brizmohun
Executive Editor
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
ICH Guidelines: Regulatory Members & Observers Show Strong Compliance
An examination of the global implementation of guidelines from the International Council for Harmonisation by regulators has yielded positive outcomes.
EU Drug Regulators Seek Help To Shape Network's Future Until 2028
More details on how the EU network of medicines agencies plan to leverage AI and foster competitiveness is now available in their draft 2025-2028 strategy, which they have published for comment.
Janssen’s Nipocalimab Among Six New EU Filings
Nipocalimab is an investigational FcRn blocker for treating generalized myasthenia gravis that was also recently filed for regulatory review in the US.
Singapore Releases eCTD Specification Package As Companies Prepare For Portal Launch
Companies will initially be able to submit their dossiers to the Health Sciences Authority via the eCTD portal on a voluntary basis.
EMA Clarifies Quality And Equivalence Testing Expectations For Cutaneous Products
New guidance from the European Medicines Agency explains how in vitro and in vivo models may be used instead of clinical data for the purpose of establishing therapeutic equivalence in a stepwise approach.
UK Expedites Cost Negotiations For Companies Conducting ATMP & Early Phase Trials
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.