Companies developing therapies that may have an adverse effect on the testes should conduct clinical trials to pin down the toxicity and whether it is reversible, the FDA says. Read More

Israeli drugmaker Alcobra’s only drug, MDX, failed a Phase 2 trial to treat Fragile X Syndrome, which can cause autism and ADHD. Read More

The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death. Read More

The FDA has published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More

Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More

The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. Read More

Because cellular and gene therapy products can have more severe effects than other types of drug products, potentially leading to organ failure, tumors or death, sponsors should include these as primary safety objectives when designing early-phase clinical trials, the FDA says. Read More

Two years after issuing guidance on data capture from electronic health records, the FDA’s Center for Drug Evaluation and Research is calling on stakeholders to help demonstrate how the use of electronic source data can help to streamline the clinical trial process. Read More

Trial sponsors are missing a big opportunity for recruitment because of fears of using social media, experts warn. Read More

A year after a consortium of stakeholders issued a proposed wish-list of approaches to the development of drugs for Duchenne Muscular Dystrophy, the FDA issued draft guidance giving drugmakers more leeway in how those drugs are created. Read More

The European Medicines Agency last month released final guidance on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More