Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

New EU Filings

Sepiapterin, PTC Therapeutics' treatment for hyperphenylalaninemia in adult and pediatric patients with phenylketonuria, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

Old Painkiller, Old Concern: EMA Revisits Metamizole’s Safety

The European Medicines Agency is reviewing the known risk of agranulocytosis in people taking medicines containing the painkiller metamizole, which is approved for use in most of the EU member states but banned in the US, the UK and other countries around the world.

Europe Drug Safety

First Drug Treatment For Myopia Among 14 New EU Filings

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.

Europe Drug Review

EU Regulators Clarify How ‘Super-Grouping’ Under New Variations Rules Will Work

Feedback is being sought on revised guidelines that tell companies how they should make post-authorization changes to their drug approvals once new rules take effect in January 2025.

Post Market Regulation & Studies Europe

ICH Cuts Burden Of Assessing Drug-Drug Interactions; Argentina Gains Membership

New guidance from the International Council for Harmonisation is designed to tackle problems companies face by having to meet different requirements around the world when evaluating the potential of DDIs for their investigational products.

International Drug Safety

EU Launches New Mechanisms To Boost Quality Of Clinical Trial And Marketing Applications

As of today, drug developers can apply to take part in two pilot programs that will involve regulators across the EU strengthening their coordination when it comes to providing companies with advice on their applications for clinical trials and marketing authorization.

Europe Clinical Trials
See All
UsernamePublicRestriction

Register