As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
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The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.
As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
