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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

US Filing For AZ’s Imfinzi In Stage III Lung Cancer

Important US filing goes ahead as AstraZeneca submits sBLA for Imfinzi in earlier-stage non-small cell lung cancer.

United States Drug Review

Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up

Roche has once again failed to convince the EMA’s key advisory panel, the CHMP, that the company’s novel multiple sclerosis treatment, Ocrevus (ocrelizumab), should be approved for marketing throughout Europe. The CHMP was considering an unusually low number of products for an opinion this month – just three – and only Teva’s generic tacrolimus got a positive recommendation. As with Ocrevus, no opinion was taken on the third product – carmustine, another generic.

Europe Regulation

CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End

Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.

Europe Approvals

Betting On A Brexit Transition Period Is A Gamble: EMA Warning For Industry

A senior official at the European Medicines Agency has warned pharmaceutical companies are taking a risk by endlessly waiting to get news on whether there would be a Brexit transition period. Drug makers still waiting to prepare for changes that may be needed once the UK leaves the EU were told 'this is your risk and your decision.'

Brexit Regulation

Ocrevus Tries Again For EU Approval Nod

Just three initial marketing authorization applications are up for an opinion this week on whether they should be approved for sale across the EU. Roche’s new multiple sclerosis treatment, Ocrevus (ocrelizumab), is one, after failing to secure a positive opinion earlier. The October meeting of the panel that will decide, the European Medicines Agency’s CHMP, is under way in London.

Europe Regulation

Half Of All EU Fast-Track Requests Fail; AZ’s Imfinzi Among Latest

The European Medicines Agency recently denied AstraZeneca’s pre-filing request for accelerated assessment of Imfinzi in Stage III NSCLC, an indication the company is hoping to make its own. It’ll be no consolation that the EMA this year seems to have rejected as many fast-track requests as it has granted.

Europe Review Pathway
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