Generics Bulletin 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
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.
Set Alert for Articles By Maureen Kenny

Latest From Maureen Kenny

Isatuximab EU Approval Decision Due

Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.

Europe Drug Review

Critical Juncture In Zolgensma EU Market Quest

If Zolgensma gets the thumbs up from the EMA this week, it will likely get formal EU approval within a couple of months. 

Europe BioPharmaceutical

EU Approval Decision Delay For BMS’s Ozanimod

BMS should find out mid-2020 whether its new MS drug will be approved in the EU.

Europe Drug Review

Yes For Shionogi But No For Lilly In Latest EMA Recommendations

The European Medicines Agency says that Shionogi’s novel antibiotic, Fetcroja, should be approved for use across Europe but that Lilly's migraine drug, Emgality, should not be authorized for the extended indication of episodic cluster headache.

Europe Approvals

EU Accelerated Assessment Tracker

EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.

Europe Drug Review

EU Fast-Track Loss For Vertex’s CF Triple Combo

Vertex is hoping for EU approval in Q4 of its cystic fibrosis triple combination therapy, Trikafta. It wants the same licence in the EU as it has in the US, where the product has already become a best seller for the company.

Europe BioPharmaceutical
See All
UsernamePublicRestriction

Register