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
Medicines Australia has expressed skepticism over the Pharmaceutical Benefits Advisory Committee’s claim that in March 2025 it will only be able to assess 32 submissions from companies that want to get their drugs subsidized under the Pharmaceutical Benefits Scheme.
mHealth data generated by smartphones and wearables show potential for enhancing the clinical evidence used in regulatory decision-making, but there are “notable challenges” that may hinder the use of such data, EU regulators say.
The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe.
The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe.
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.
The Therapeutic Goods Administration appears to share similar safety concerns regarding Leqembi as those expressed by the European Medicines Agency when it rejected the drug in July.