AI

While regulators are “catching up” to the use of artificial intelligence in clinical development, some skepticism remains around the use of AI to generate synthetic patient data, says Alexion’s Nick France.

Artificial intelligence in pharmaceutical manufacturing is increasing in prevalence, offering a unique opportunity for global regulators to align on expectations, industry group IFPMA says.

Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.

South Korea starts development of AI-supported system to dramatically shorten drug approval reviews and announces new national strategy for AI in biopharma targeting 10x expansion in the country’s new drug pipeline.

Neonatal drug development struggles with the lack of a standard of care and pervasive off‑label use, but the FDA’s growing preparedness for AI and real‑world evidence approaches offers an opening to harness NICU data to accelerate neonatal‑focused therapies.

Pre-clinical models can help pharma companies to make better decisions on which drug candidates to take forward, but industry will need to work with academia to address shortcomings in the maturity of these technologies, UK trade association ABPI says.

Data from virtual, artificial intelligence-based labs can help guide the clinical development pathway for pharmaceutical companies. But regulatory involvement will be key to assessing whether a virtual model is accurate, the CEO of Turbine Labs tells the Pink Sheet.

A Pink Sheet analysis found that of more than 87,000 written comments to a Vaccines and Related Biological Products Advisory Committee meeting docket, only a fraction were anti-vaccine, and many were the same or similar statements sent repeatedly.

Pharma firms are keen to ensure that artificial intelligence tools used in the earlier stages of drug discovery are excluded from the “onerous scope” of the EU’s AI Act, as this could “defeat” the benefits of using this technology, says Clifford Chance’s Stephen Reese.

At a recent discussion in South Korea, CEPI and other participants explored ways to discover new health cooperation models that go beyond traditional aid approaches and to strengthen Korea’s role.

If the EU’s controversial Artificial Intelligence Act applies restrictive rules to pharmaceutical research and development activities, the UK could benefit from offering a more favorable regulatory environment, top lawyer Stephen Reese explains.

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.