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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

He focuses his practice on EU regulatory affairs, litigation and competition law issues affecting the life sciences sector in Europe. In addition to advising on EU life sciences matters, Maarten also handles competition litigation at the EU and national levels. Maarten has significant competition law experience in a variety of sectors.

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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. EU competitiveness Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies.

Pharma 64
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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

11 The THR pathway was created with the purpose of establishing a simplified registration procedure for all traditional herbal medicines that do not fulfil the requirements for the MA (strict) pathway under Directive 2001/83/EC. She also holds post-graduate diplomas from Oxford (IP Law) as well as King’s College (EU Competition Law).

Marketing 103
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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4

Medicine 116
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

She has experience on issues arising during the lifecycle of medicinal products, including optimisation of IP regulatory rights, advertising, product liability, competition and market access issues. Directive 2001/83 (as amended). The Impact of Biosimilar Competition in Europe, IQVIA, December 2021. EMA Biosimilars Q&A.

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Achieving scale up success under economic uncertainty

European Pharmaceutical Review

Market uncertainty Rising operational costs, stiffening competition, ongoing patent expirations, evolving environmental and social governance requirements and increasing pressure on drug prices mean the industry will have to navigate thoughtfully to be successful amid this complicated mix of financial and strategic risks.

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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. By this same virtue, PROTACs are able to degrade previously undruggable targets, which provides a major competitive advantage for this modality if shown to be true.