Neena Brizmohun
Executive Editor
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
Freeline, Wugen & Jnana Secure EMA PRIME Designations For Novel Treatments
A one-time gene therapy candidate for Gaucher disease, an allogeneic CAR-T cell therapy for difficult-to-treat blood cancers, and a potentially first-in-class drug for treating hyperphenylalaninemia have made it onto the European Medicines Agency’s priority medicines scheme.
‘Engage With Us,’ EMA Urges Psychedelic Drug Developers
Psychedelic drug developers are focusing on the US market, and there are no approvals in sight in the EU. The European Medicines Agency wants to change that.
Pfizer Finally Wins English Funding For Sickle Cell Drug Oxbryta After Bumpy Ride
After several rejections by NICE and an appeal by Pfizer, the company has reduced the price for its first-in-class sickle cell disease drug to a level that the health technology assessment institute deems acceptable.
EU CHMP Opinions And MAA Updates
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.
Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod
The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.