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EU proposes new blood, tissues and cells Regulation

European Pharmaceutical Review

The proposal is a result of a comprehensive revision of the existing EU legislation, including the consultation of a wide range of BTC stakeholders and international organisations, such as the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe.

Safety 116
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Realising milestones with gene therapy for SMA

European Pharmaceutical Review

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. percent of Europe’s annual healthcare spend. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach. Stakeholder education is critical to achieving this.

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The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

border healthcare, specifically by repealing Article 15, which originally laid down the modalities and principles for co-operation between Member States in assessing new health technologies. governmental healthcare organisations. Vincenzo Salvatore is of counsel and leader of the Healthcare and Life Sciences Focus Team at BonelliErede.

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

Pharmaceutical Technology

The products that are authorised in EU are largely the same as other regions,” argued European Commission Directorate-General for Health and Food Safety Florian Schmidt, during the same online event. But others do not accept that the EU is less competitive for the pharma industry than North America and Asia. You can compare timelines.

Pharma 64
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

Marie advises clients in the pharmaceutical, biotechnology, medical devices, chemicals, cosmetics and food sectors in proceedings before both national and European courts and the regulatory agencies in the UK and across Europe. Chris was named a ‘Rising Star’ in the 2022 Legal 500 Rankings for Life Sciences and Healthcare.

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Reality Bites: Disappointment in the R&D Sector

Pharmaceutical Technology

This is confirmed by the Centre for Medicines Research International which shows in 2004 that more than 20% of the money invested in R&D by ten of the largest pharmaceutical companies went on line extensions, as opposed to new development projects. %, while R&D accounts for just 17.1%

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Cancer: Progress but a long way to go

World of DTC Marketing

In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found. But it’s’ still the leading cause of cancer deaths.