Clinical Trials/R&D

But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.

The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation that require clarification, says pharmaceutical industry federation EFPIA.

The agency wants sponsors to start with three core symptoms common across cancer therapeutics and then add more treatment-related adverse events from item libraries based on a drug’s mechanism of action and other factors.

The draft guidance addresses specific requirements for oligonucleotide-based medicines that are not answered in existing guidance documents, and has been two years in the making.

The US FDA surprised some observers when it advised Agenus against filing for accelerated approval of the CTLA-4/PD-1 combination, but the agency has been cracking down on confirmatory trial requirements recently to better ensure the studies will be finished.

Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.

Evidence generated through an EU public-private funding initiative has resulted in a new biomarker method for measuring the level of Alzheimer’s disease in a person’s brain, which drug developers can use during clinical trials.

From the US FDA’s ISTAND Program to EU’s Melloddy Initiative, and from the global challenges of real-world data to the opportunities in India, Parexel’s EVP for Clinical Data and Digital Services, chief strategy officer and India head speak on a range of topics in this interview with the Pink Sheet.

Establishing multi-site network centers for rare diseases can help advance clinical research, but “onerous” regulatory compliance issues are a barrier that must be overcome, a clinical academic says.

As well as planning action to improve the EU’s competitiveness in the life science sector, the European Commission has confirmed that it will propose new legislation to reduce the bloc’s reliance on overseas suppliers of medicines as a way of tackling drug shortages.

CDER real world evidence policy head John Concato said the FDA could approve a new labeled use based only on real-world evidence, but made clear the approach is challenging. 

A prominent rare disease researcher has praised the UK’s Department for Health and Social Care for its transparency and willingness to work with experts, but said that regulatory systems needed to speed up to facilitate patient access to innovative treatments.

The latest report on the competitiveness of the UK’s life sciences sector shows that the nation “continues to underperform” on its potential in terms of the adoption of new treatments and innovation, according to industry body the ABPI.

The use of the RPT is to no longer be required in any text of the European Pharmacopoeia and medicine developers will have to select a suitable in vitro test to control the pyrogenicity of their product.

While the new Labour government includes several “life sciences champions” and has pledged to turn the UK into a life sciences powerhouse, the UK BioIndustry Association head says major changes are unlikely for the pharma and biotech industry.

The European Commission’s new research and innovation funding scheme should have a higher budget and be more “flexible and fit-for-purpose” than the existing “one-size-fits-all approach,” pharma industry federation EFPIA says.