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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

Dova Aims For Accelerated Assessment In EU For Avatrombopag

Will the European Medicines Agency decide this week that Dova Pharmaceuticals’ eventual marketing authorization application for avatrombopag should be fast-tracked? If it does, the potential new thrombocytopenia therapy would join just a handful of products that are being reviewed under the EMA’s accelerated assessment pathway.

Review Pathway Regulation

Clovis Confident, Portola Not: CHMP Decides On EU Marketing Applications

Eight EU marketing authorization applications are up for an opinion this week from the CHMP, the European Medicines Agency committee that recommends whether or not products should be approved.

Drug Review Approvals

Five Drugs Set For EU Approval, Including Two Orphans

The EU’s CHMP has recommended approval of a number of products including Pfizer’s Mylotarg for acute myeloid leukemia, Ammtek’s Amglidia for neonatal diabetes, and BioCryst Pharmaceuticals/Seqirus’ Alpivab for uncomplicated influenza.

Approvals Europe

EU CHMP Finalizes Outstanding Issues On Aimovig And Symproic

EU regulators meeting in London are finalizing the outstanding questions they have for companies whose products are approaching the final stages of the approval process.
Europe Drug Review

Decision Time At CHMP: Portola and Aegerion In Spotlight

Nine marketing authorization applications, 15 variation of therapeutic indication requests, two requests for accelerated assessment and a re-examination procedure. These are some of items on the agenda at the latest meeting of the EMA’s key advisory panel, the CHMP, which is under way in London. 

Europe Regulation

Bumper Number Of 'Oral Explanations' Due At CHMP Meeting

An unusually large number of companies are due to appear this week before the European Medicines Agency’s key advisory panel, the CHMP, to answer questions about initial marketing authorization applications or indication extension requests. The CHMP has questions regarding nine different products.

Europe Regulation
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