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.
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Latest From Neena Brizmohun
New EU Approvals
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Merck Sharp & Dohme's Ebola vaccine, Ervebo. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
The Stakes Are High So Get It Right
The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. Consultant Kate Dion highlights to In Vivo helpful tips for companies facing this daunting situation.
Vertex Inks Another Orkambi Reimbursement Deal After France Says Yes
The reimbursement deal will allow cystic fibrosis patients as young as two years of age to access Orkambi in France for the first time.
Celgene Gets Another Myeloma CAR-T Accepted Onto EMA’s PRIME
Bristol-Myers Squibb’s newly acquired company Celgene is one of two drug sponsors that this month made it onto the European Medicines Agency’s priority medicines scheme. The other is Achillion Pharmaceuticals, which is developing a treatment for paroxysmal nocturnal hemoglobinuria.
European 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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.
ViiV Seeks Speedy EMA Review For Last-Resort HIV Drug
ViiV Healthcare has asked the European Medicines Agency to accelerate its review of fostemsavir when the company files for pan-EU market approval of the product.