EU

European Commission opens public consultation on Orphan and Paediatric Regulations

Jacqueline Bore

The European Commission has embarked on the latest round of evidence gathering to support its review of pharmaceutical incentives, launched in response to the Council Conclusions of June 2016. The Health and Food Safety Directorate opened a public consultation on the Orphan and Paediatric Regulations on 18 October 2018. This joint evaluation will assess whether Read More

European Commission’s proposal for a Regulation on Health Technology Assessment clears another hurdle

Jacqueline Bore

The European Parliament has adopted the legislative report of its committees on the European Commission’s proposal for a Regulation mandating joint health technology clinical assessments of medicinal products and medical devices. The aim of the proposal is to promote co-operation at EU level in assessing the added benefits of new health technologies, with the aim that Read More

Federal Circuit upholds finding that Broad Institute CRISPR patents in plant and animal cells do not overlap with UC Berkeley patents

Jacqueline Bore

CRISPR-Cas9 is a remarkable gene editing technology which has the potential to revolutionise the development of medicines, particularly those for genetic diseases and cancer. Pharmaceutical companies have been quick to partner with innovators who have begun to find ways to commercialize CRISPR-Cas9, both as a research tool and as a route to the development of Read More

Getting ready for the EU MDR: New guidance documents available for manufacturers

Eveline Van Keymeulen

During the summer months of July and August, the European Commission has published five documents aimed at guiding manufacturers and other economic operators through the changes implemented by the EU Medical Devices Regulation (MDR) and the EU In-Vitro Diagnostic Medical Devices Regulation (IVDR). Both regimes will be fully applicable on 26 May 2020 and on 26 Read More

UK government publishes plans for the Life Sciences sector in the event of a no-deal Brexit

Jacqueline Bore

The UK government has published a series of guidance documents setting out how it plans to regulate the Life Sciences sector if the UK leaves the European Union on 29 March 2019 without an agreement with the remaining EU-27 Member States. The UK government emphasizes that significant progress has been made in negotiations with the Read More