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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.
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Latest From Maureen Kenny

EU Accelerated Assessment Tracker: Nine Definites So Far From 24 Requests In 2018

In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.

Europe Review Pathway

Brexit: UK Gov’t Warns Against Medicines Stockpiling By NHS And Public

The UK government has issued guidance on actions the public health and care system in England should take to prepare for and cope with a potential “no deal” exit by the UK from the EU at the end of March next year. The government is also very clear on what it does not want providers such as hospitals and community pharmacies to do – stockpile medicines.

Brexit United Kingdom

Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations

Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP.  Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn an application for another.

Europe Regulation

CHMP Delays Review of Portola's Ondexxya; Who Will Pass Muster?

With its final meeting of the year under way, the EMA's medicines evaluation committee, the CHMP, will bring seasonal cheer for some companies if it decides their products merit EU approval. New treatments from Shionogi and Medac are up for an opinion. A planned appearance by Portola before the panel to answers questions relating to its marketing application for Ondexxya/AndexXa has been cancelled and the review period for the marketing authorization application for the product extended.
Europe BioPharmaceutical

Brexit And Cooperation: Insights From Danish Medicines Agency Head Thomas Senderovitz

It was inevitable that Brexit would be the key theme of an interview with Danish Medicines Agency head Thomas Senderovitz earlier this year. The senior European regulator oversees one of the agencies that has taken on new staff to help deal with the impact, in drug regulatory terms, of the vote by the UK in June 2016 to leave the European Union. Senderovitz also chairs the management group of the EU Heads of Medicines Agencies network.

Leadership Outlook 2019

Brexit And Cooperation: Insights From Danish Medicines Agency Head Thomas Senderovitz

It was inevitable that Brexit would be the key theme of an interview with Danish Medicines Agency head Thomas Senderovitz earlier this year. The senior European regulator oversees one of the agencies that has taken on new staff to help deal with the impact, in drug regulatory terms, of the vote by the UK in June 2016 to leave the European Union. Senderovitz also chairs the management group of the EU Heads of Medicines Agencies network.

Leadership Policy & Regulation
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