The European Commission says it is working on stakeholder responses to its proposed EU pharmaceutical strategy and expects to publish a communication by the end of the year outlining the main legislative and other actions that will be taken under the strategy.
EU Pharma Strategy To Balance Innovation Incentives & Competition
Stakeholders Have Different Views On ‘Unmet Medical Need’
Delegates at this week’s TOPRA conference heard the European Commission’s “holistic” vision of what it would like to achieve through its pharmaceutical strategy, including incentives for innovation, security of the supply chain, product shortages, real world evidence and big data, and the availability and affordability of medicines.
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Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.
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France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.
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The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.
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A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.
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Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.
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France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.
• By
The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.