Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Maureen Kenny

Executive Editor

London, UK
Maureen's expertise in bringing exclusive, business-critical content to the expanded Pink Sheet audience builds upon her many years' experience as an editor and reporter. Most recently, Maureen headed Scrip Regulatory Affairs, an indispensable publication for both pharmaceutical and medtech regulatory affairs professionals worldwide. She managed the publication's move from print to digital. Previous leadership roles also include being editor of Clinica Medtech Intelligence and acting editor of Scrip Intelligence. She chaired the DIA EuroMeeting plenary session in Paris in April 2015 and spent two years in New York covering the pharmaceutical industry in the US, Canada and, being a fluent Spanish speaker, Latin America. Maureen is based in London.

Latest From Maureen Kenny

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.

European Performance Tracker Review Pathway

Accelerated Assessment Success In EU For CSL Behring And Roche

There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted. 

Review Pathway Gene Therapy

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from, among others, Janssen, Sanofi, Boehringer Ingelheim and Mirum.

European Performance Tracker Review Pathway

Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa

Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year. 

Europe Review Pathway

Cilta-Cel Reverts To Standard Review In EU

Janssen says the review at the European Medicines Agency of its marketing authorization application for cilta-cel reverted to standard timelines because the EMA wanted a GMP inspection and provision of a GMP certificate, "which did not allow continuation of the accelerated assessment timetable.”

Europe Review Pathway

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to experimental products from Atara, Calliditas, and Roche. 

Europe Review Pathway
See All
UsernamePublicRestriction

Register