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 Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
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 Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
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.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.