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
The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said today.
The developers of survodutide and elsunersen will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
Applications from drug companies should also include a commercial proposal, says Pharmac.
Health technology assessment institute NICE is scheduled to appraise Eisai/Biogen’s lecanemab and Eli Lilly’s donanemab next year.
While things are starting to look up for the commercial clinical trial ecosystem in the UK, more progress is needed to improve industry’s confidence in the country as a destination for research, especially revenue-generating Phase III trials.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Jaypirca, Eli Lilly’s treatment for relapsed or refractory mantle cell lymphoma.