Clinical Trials
Consistent, AI-verifiable clinical and SEC disclosures are now essential to protect valuation and avoid litigation. Misalignment creates measurable regulatory, financial, and legal risk, while disciplined, synchronized disclosure strengthens credibility and reduces exposure.
DARI is an AI enabled framework that scores how well clinical trial disclosures align across SEC filings, registries, press releases, and presentations, identifying risks in timing, accuracy, consistency, governance, and tone to flag regulatory or litigation exposure.
The UK MHRA says it is ready to deliver the new Clinical Trials Regulation, which aims to balance faster review of trial applications with greater flexibility to deliver a competitive, innovation-friendly clinical research ecosystem.
The European Medicines Agency wants feedback on a reflection paper that aims to address a lack of “uniformity” in cardiovascular toxicity endpoints in clinical trials for cancer drugs.
As Europe races to reclaim its share of commercial clinical trial activity, regulators are testing whether faster approvals and shorter setup timelines will be enough to restore sponsor confidence, attract biotech investment, and secure the region’s place in global drug development.
The EU public‑private Trials@Home consortium put seven decentralized clinical trial elements to the test through its proof‑of‑concept RADIAL study to generate learnings on how to scale such trials in the future.
FDA officials want to see more use of alternative approaches to preclinical pediatric safety analyses, but for now are ready to be patient rather than issue mandates.
FDA draft guidance formalizes 2024 advisory committee recommendations and would allow earlier, more precise indicators of cancer clearance in multiple myeloma to support accelerated approval and reduce reliance on overall response rate.
Medsafe’s latest update of New Zealand’s clinical trial guidelines aligns with international standards and clarifies expectations on patient‑centric design, streamlined safety reporting, and other regulatory requirements.
As healthcare shifts rapidly into the home, clinical trials are only beginning the long transition needed to keep up.
The European Medicines Agency has not “always fared favorably” compared to other countries such as the US when it comes to drug approval timelines, but the reform of the EU pharma legislation is a key opportunity to “think out of the box,” says the agency’s head of therapeutics areas.
Decentralized clinical trials are an operational model to deliver studies in a different way, but their future hinges on demonstrating scientific advantages beyond logistical convenience.
New draft guidance includes case studies where Bayesian approaches have been used, including several examples from the Complex Innovative Trial Design program.
Amgen's Bradner explained the rise of China on the global biopharma stage, while Flagship's Afeyan called out US government policies on biomedical research. Plus, concerns about the FDA's gene therapy capacity in our conference notebook.
Canada’s health care products regulator is seeking to strengthen its oversight of decentralized clinical trials.
Registrational trials will be smaller, shorter and less expensive with change in hip bone mineral density available as a primary endpoint, the US FDA's first qualification of a surrogate endpoint under the 21st Century Cures Act.
Pink Sheet editors and special guest Michael McCaughan discuss the legacy of long-time Oncology Center of Excellence Director Richard Pazdur, who retired from the FDA in December.
Richard Pazdur joined the US FDA almost a decade after the accelerated approval pathway was invented, but no one played a larger role in shaping its use in the 2020s.
Richard Pazdur is leaving the US FDA amid a time of unprecedented turmoil and uncertainty, but that should not obscure the transformative impact he had on oncology in the US and around the world.
Sponsors evaluating the costs of introducing decentralized elements into clinical trials should weigh these against the added value they bring to patients.