Advanced Technologies

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.

Sponsors making “big statements” with “no evidence” to back them up is one of the biggest issues faced by the UK drug regulator when it is assessing the regulatory dossiers for advanced therapy medicinal products, a quality assessor from the Medicines and Healthcare products Regulatory Agency says.

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.

Denmark’s medicines regulator has published guidance to support the progression of investigational advanced therapy medicinal products into first-in-human trials by clarifying the expectations for preparing investigator’s brochures.

Japan's regulatory authorities recommend approval of products including a cell therapy, while setting reimbursement prices of newly approved drugs and cutting some others following cost-effectiveness assessment.

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.

Findings from a new report on electronic Product Information pilots projects in Europe reveal a landscape of innovation, collaboration and cautious optimism, according to a group of pharmaceutical industry bodies.

GLOBE resurrects Trump’s 2020 effort to try aligning Medicare Part B prices with lower prices abroad, but key aspects of the model have evolved and are noteworthy even if the demonstration does not advance as planned.

The FDA proposed conditions for eliminating six-month animal studies in mAb development and gave examples when shorter-duration studies could be eliminated.

Platform technologies in the EU are set to benefit from greater regulatory flexibility under the upcoming EU pharma legislation overhaul. Industry is urging policymakers to “avoid misalignment” with other global regulators, including in the US.

The overhaul of the EU pharmaceutical package is expected to introduce two new regulatory “concepts” relating to platform technologies. A European Commission expert explains how the changes could impact industry and what the expected benefits are.

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.