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
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
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 Lynkuet, Bayer's treatment for moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer.
A new reliance pathway under which regulators will rely on each other’s assessment reports strengthens the goals of key continental health initiatives, including the newly formed African Medicines Agency.
Denecimig, Novo Nordisk’s prophylaxis treatment for hemophilia A, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
The European Medicines Agency has begun evaluating the EU marketing applications for a new batch of drugs, including products from Incyte, Sanofi and Novo Nordisk that target hidradenitis suppurativa, rabies and hemophilia A, respectively.
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.