Clinical Trials/R&D

Psychedelic drug developers are focusing on the US market, and there are no approvals in sight in the EU. The European Medicines Agency wants to change that.

The EMA received more than 1,000 responses to its draft reflection paper on AI in drug development, some of which will be incorporated into the final document, an agency representative told this week’s RAPS Euro Convergence 2024.

After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.

Developing drugs for some rare diseases is “just not commercially feasible,” meaning that alternative approaches, such as funding through venture philanthropy and not-for-profit models, need to be explored, a gene therapy professor has said.

Similar to drug master files, MMFs would allow models to be reused, but critical issues, such as protection of proprietary information, still must be resolved.

The MHRA’s regulatory strategy on AI outlines key areas where this technology could be used to improve the agency’s own processes, and says that the use of AI to develop drugs will not change the questions it asks companies.

While the UK’s drug regulator, the MHRA, has “pulled its socks up massively” in recent months, its poor performance was highlighted as a top cause of the UK’s faltering clinical trials ecosystem by a former health minister.

The UK’s drug regulator, the MHRA, has taken a hit in terms of capacity and funding post-Brexit, and could benefit from government backing to rebuild its regulatory capacity, a leading venture capitalist has said.

The European Commission’s landmark AI Act will introduce strict new rules for AI systems, with the exception of products used solely for scientific research, something that could be good news for pharma, according to industry body EFPIA.

The European Health Data Space is expected to give researchers, industry and public bodies access to large amounts of high-quality health data for the development of new treatments and vaccines. The European Parliament has also approved new rules on Substances of Human Origin.

New draft guidance pushes industry to broaden clinical trial eligibility criteria while offering some protection from fears it could hurt efficacy results.

House appropriations subcommittee chair Andy Harris, R-MD, says the agency ignored several important factors in recommending that marijuana be reclassified as a Schedule III drug; Califf tells ranking member Sanford Bishop, D-GA, that although work is progressing on animal testing alternatives, 'we're a long way right now' from eliminating animal studies before first-in-human trials.

Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.

Great Ormond Street Hospital is piloting a new approach to gene therapy delivery in which it will submit a marketing authorization application to the UK regulator for a lentiviral gene therapy used to treat ADA-SCID, a rare disease.

Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.

Sponsors need guidance on ethics requirements and clarity around national regulations to conduct cross-border clinical trials in the EU, a multi-stakeholder forum says.