Neena Brizmohun
Her areas of expertise include the cutting-edge early market access schemes that are being trialed around the world for taking drugs and medical devices to market faster. She is also interested in initiatives for harmonizing regulations at the global level as well as issues affecting clinical trials, manufacturing and post-market safety monitoring. She explores the challenges and opportunities that these issues introduce for both industry and the regulators and is on a constant look out for what might be coming next.
A scientist by training, Neena started her journalistic career at Informa in 1997. She has been the deputy editor of Scrip Regulatory Affairs since 2007. Prior to that, she worked as the science editor for Clinica Medtech Intelligence. Before becoming a journalist she worked as a biomedical scientist at St Thomas' Hospital in London for 10 years.
Latest From Neena Brizmohun
High-Stakes Meeting With EMA On The Cards For Oncopeptides’ Pepaxto
Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.
EU Marketing Decisions For New Drugs Imminent For Sanofi, PTC, Calliditas & Others
The European Medicines Agency’s human medicines committee, the CHMP, is expected to decide whether 11 drugs should be recommended for marketing approval during its latest monthly meeting, which started today.
Work Presses On To Harmonize Global Expectations On Using Modeling & Simulation
The level at which model-based analyses is integrated into regulatory decision-making can vary between regulatory agencies, from application to application and within agencies for similar submissions, leading to missed opportunities, says the International Council for Harmonisation.
Two ‘Step-Changing’ Drugs For Waldenström’s Macroglobulinemia Fail To Win English Funding
NICE has issued final guidance for Imbruvica and preliminary guidance for Brukinsa, saying that while clinical evidence supports using the BTK inhibitors for WM, it is not convinced that either drug will be a cost-effective use of National Health Service resources.
PRIME Dry Spell Over As EMA Says Yes To Pfizer & BioCryst
This year’s first designations under the European Medicines Agency’s priority medicines scheme have gone to a maternal vaccine for an infection in newborns and a treatment for an ultra-rare bone disorder.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Quviviq (daridorexant), Idorsia's treatment for adult patients with insomnia.