The European Commission’s pharmaceutical legislation overhaul could result in a loss of 50 expected new products by 2035 and an annual fall in R&D spending of €2bn, the European pharma industry federation EFPIA claims.
The European Commission’s plans to cut the standard regulatory data and market protection periods for new drugs as part of its proposed pharmaceutical legislation overhaul could see a 22% drop in the number of new drugs expected to be developed by 2035, a new report from Europe’s pharma industry federation EFPIA has warned.
EFPIA has voiced its concerns about the commission’s draft revisions, particularly those relating to a reduction in the statutory regulatory...
Technical discussions on the EU pharmaceutical legislative reform are underway at the Council of the EU.
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.
In this final article in a series on the ongoing amendments to the pharmaceutical reform package, the Pink Sheet looks at the tougher environmental risk assessment requirements that pharma companies are likely to face in the not-too-distant future.
A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.
Congressional Budget Office responses to questions from US lawmakers on pharmacy benefit managers could add to the momentum for PBM reforms to go further than the current leading proposals.
Letter to US FDA by a bipartisan group of House members cites clinical trials sponsored by Eli Lilly and Pfizer as examples of a widespread industry practice. But any legislation to curtail such practices is not expected to be part of the BIOSECURE Act.
The agency is clearly on the radar of former President Trump and his new coterie of tech moguls.
