Neena has over 20 years of experience covering regulatory, business and market access developments that impact pharmaceutical and medical device companies. 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
Health Canada wants drug sponsors to start answering questions relating to disaggregated data for sex, age and race.
Drugs combining codeine and ibuprofen were among the latest products for which the European Medicines Agency has recommended new risk minimization measures –Imbruvica and terlipressin-containing medicines were the others.
Santhera Pharmaceuticals’ vamorolone for treating Duchenne muscular dystrophy is among the latest medicines that have been submitted for review for potential pan-EU approval.
Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.
The sponsors of Alsitek and quizartinib are hoping that new data generated for the drugs will resolve the concerns raised by the European Medicines Agency when it previously rejected the products for marketing in the EU.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Nulibry, BridgeBio/Sentynl's orphan drug for treating molybdenum cofactor deficiency Type A.