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
Outlook Therapeutics is hoping to secure EU marketing approval for the first ophthalmic formulation of bevacizumab.
Two new electronic catalogs of real-world data sources and studies offer an improved and more efficient service to help drug companies, regulators and researchers find adequate data sources to generate real-world evidence for regulatory purposes, says the European Medicines Agency.
Ultragenyx’s antisense oligonucleotide for treating Angelman syndrome and Sangamo’s gene therapy for Fabry disease are the latest products to make it onto the European Medicines Agency’s priority medicines scheme.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Omjjara, GSK's treatment for splenomegaly or symptoms in adult myelofibrosis patients with moderate to severe anemia.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Diversification of global supply chains, drug stockpiling, and boosting Europe's capacity to produce and innovate in the manufacturing of critical medicines and their ingredients are among the topics to be addressed by the European Commission’s forthcoming Critical Medicines Alliance.