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Reacting to concerns about good clinical practice at sites run by one of its trial contractors — Boston-based Care Access — Pfizer announced it will drop Care Access sites from its phase 3 Lyme disease vaccine trial, losing about 3,500 participants. Read More
Patients currently enrolled in the study will continue taking the investigational drug, but no new patients will be enrolled until the partial hold is lifted. Read More
A single injection of Eiger Biopharmaceuticals’ peginterferon Lambda, an immune defense-stimulating protein, cut the rate of COVID-19 hospitalization by 51 percent compared to placebo, researchers reported in the New England Journal of Medicine. Read More
Galapagos reported disappointing topline results from a phase 3 trial of its Janus kinase (JAK) inhibitor filgotinib for patients with moderate to severe Crohn’s disease (CD) and said it will not file for marketing authorization in Europe. Read More
The European Medicines Agency (EMA) has launched a new pilot program that gives some study leeway to drugmakers working on pediatric investigation plans (PIP) for innovative children’s medicines. Read More
The European Medicines Agency (EMA) is requesting public comment on its new multi-stakeholder platform, Accelerating Clinical Trials (ACT) EU, for improving clinical trials within the trade bloc. Read More
Nearly four dozen pediatric clinical trials involving more than 3,600 children failed to publish their findings on ClinicalTrials.gov or in scientific literature, according to a new analysis by U.K.-based trial transparency advocacy group TranspariMED and other non-U.S. researchers. Read More
The FDA has launched a pilot program to increase the efficiency and predictability of biosimilar development, and decrease the cost and time of development — and has released a “research roadmap” to help researchers reach those goals. Read More