AI

An India-EU trade deal sets ground for a free trade agreement to lower tariffs on pharma, though an investment protection agreement – likely influencing data exclusivity – will be concluded later. Will the US now reconsider its India tariffs?

Using artificial intelligence in drug discovery and development could have huge benefits for companies, but a key challenge will be addressing how data is used to train AI tools and managing intellectual property issues, says Clifford Chance’s Stephen Reese.

The FDA is exploring a new model that would let venture capital firms act as prime contractors, giving their startups direct access to federal contracts.

Human-centric design, a risk-based approach and lifecycle management are among the ten guiding principles for artificial intelligence (AI) that pharma should follow when using AI in the drug lifecycle, the FDA and EMA say in a joint document.

The UK health care products regulatory agency is inviting industry to share its views on how artificial intelligence in health care should be regulated, with input set to shape future rules and guidance.

The UK MHRA has become the first major regulator to ask clinical trial sponsors to provide details on their use of artificial intelligence and machine learning as part of preparations for good clinical practice inspections.

The US FDA’s cell and gene therapy group has “scores” of active INDs using AI, and is eager to see it grow, but challenges remain with employing AI for decision-support tools, including the lack of good quality datasets to train models.

FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.

With the roll out of agentic AI, the US FDA continues to expand its capabilities, following the launch of Elsa, its generative AI tool in May.

New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.

Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.

Smaller datasets are being leveraged to develop and train artificial intelligence models, which can help overcome the limitations of small patient numbers in rare disease settings, CDER staffers wrote in NEJM AI.

A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.

AI is moving from blue-sky potential to specific applications in drug development, streamlining pharmacovigilance and clinical trial design, but strong governance remains essential to ensure transparency and reliability.

Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.

Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.

Sanofi’s EU regulatory science and policy head draws on a “nightmare” experience with using a generative AI tool to compare versions of the draft EU pharma reform text to explain the benefits and limitations of artificial intelligence tools in regulatory affairs.

A new government-backed initiative is set to explore the use of AI in predicting side effects from drug interactions – a development that could cut costs and late-stage trial failures for pharma companies.

The UK MHRA is looking to support drug sponsors in using in silico data during the drug development process – a move that will reduce the use of animal models.

Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.