EU Proposals On R&D Funding Transparency Could Increase Pressure On Companies Negotiating Drug Prices
The draft Directive that was published last month with a draft Regulation for reforming the EU’s medicines legislation includes proposals for companies to publicly declare financial support received from a public authority or publicly funded body for R&D activities.
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EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.
Danon Disease Gene Therapy & TGCT Treatment Win EMA PRIME Designations
Promising early clinical trial results from Rocket and Abbisko respectively helped the companies secure their places on the European Medicines Agency’s priority medicines scheme, which aims to help speed up the development and regulatory review of treatments for unmet medical needs.
Companies Weigh In On How To Tackle EU Regulatory & Reimbursement Barriers To Digital Therapeutics
When it comes to digital therapeutics in Europe, EFPIA says there is a lack of harmonization in the regulatory requirements, and only Belgium and Germany offer value assessment, reimbursement and funding pathways, with more intermittent offerings in countries like France and UK.