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Huge inequalities found in access to myeloma clinical trials in Europe, says MPE

pharmaphorum

Led by the MPE CEE Workgroup on Access, the report – Addressing access barriers to myeloma clinical trials in Central and Eastern Europe – evaluated the number of clinical trials held in CEE countries between 1 January 2001 and 28 September 2020. Approximately 50,000 people in Europe are diagnosed with myeloma each year.

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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

This can lead to severe health risks for the patient, in which case the pharmacy would be held liable. Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC.” Article 63 EMA (29 January 2020).

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

This suggests that any of the modelled changes to the regulation could lead to a decrease in the number of OMPs developed… Some of the assessed changes to the regulation could undermine the business model under which OMP?focused One of the key priorities of the EU’s strategy is to encourage innovation to solve unmet medical needs.

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Jim Lefevere

Pharma Marketing Network

Since joining a Fortune 100 company in 2001 as a marketing manager for Roche, the world’s largest biotech company, global pioneer with 94K+ employees in 100 countries, and annual revenue of $53B, Jim has been promoted into multiple executive positions such as Global Marketing Manager, Global Group Manager, and Head of Global Digital Marketing.

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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

Stakeholder reaction to original EC proposals suggests that changes are considered more favourable for generic/biosimilar manufacturers, given reduced RDP periods could lead to earlier generic/biosimilar entry for both non-orphan and orphan drugs ( see Figure 2 ). By contrast, orphan drugs could become less profitable, more risky investments.

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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

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